An Open-label, Randomized, Comparative Phase III Study Including Patients With CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer.
Phase: PHASE3
Conditions: Gastric Adenocarcinoma
Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd

 
 
 
 
 
A 
multicenter, 
randomized, 
controlled, 
open-label, 
Phase 
III 
confirmatory clinical study comparing the efficacy and safety of IMC002 
with investigator's choice of therapy in adult subjects with inoperable 
locally advanced or metastatic gastric or gastroesophageal junction 
adenocarcinoma who have received at least two prior lines of therapy 
and are positive for CLDN18.2 expression. 
Clinical research protocol 
 
Project number: IMC002-RT02-RCT 
Solution version 
number: 
V 2.1 
Version Date: 
September 27, 2025 
 
 
 
 
Confidentiality Statement 
This protocol is provided only for review by investigators, ethics committees, and relevant regulatory 
agencies. All information related to this drug contained herein is proprietary to the sponsor, Suzhou Yimufeng 
Biotechnology Co., Ltd. Without the written consent of the sponsor, please do not disclose or disclose any 
information related to this drug to any third party unrelated to this trial, except for providing necessary 
explanations to potential participants in this clinical trial. 
 
Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd. 
 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Plan version number / version date: V2.1 / September 27, 2025 
Page 19 2 NUMPAGES  
 
Principal Investigator's Protocol Signature Page 
I have read this trial protocol (Version Number : V 2.1 Version Date: September 27, 2025 ) 
and confirm that I agree to conduct this study in accordance with this protocol. I agree to perform 
my duties in accordance with the Declaration of Helsinki, GCP, other applicable regulations, and 
this study protocol. 
This study may only be conducted after obtaining approval from the Ethics Committee. 
During the implementation of the study, I will strictly adhere to the requirements of this protocol. 
If the protocol needs to be modified, it may only be implemented after notifying the researcher 
and obtaining their consent, and after re-approval or filing of the Ethics Committee, unless 
measures are necessary to protect the safety, rights, and interests of the subjects. 
At the same time, as the principal investigator of this trial, I coordinate the overall progress 
of the trial. 
 
 
Research Unit: 
 
Name: 
 
sign: 
 
date: 
 
 
 
 
 

Protocol number: IMC002-RT02-RCT 
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Sponsor 's proposal signature page 
Our company will conscientiously fulfill its sponsor responsibilities in accordance with 
Chinese Good Clinical Practice (GCP) regulations and will be responsible for initiating, applying 
for, organizing, and funding this clinical trial. We will assume legal liability for the medical 
expenses and appropriate financial compensation for any trial-related injuries or deaths incurred 
by subjects during the clinical trial, and will provide legal guarantees to the investigators. We 
agree to design and conduct this clinical trial in accordance with this protocol ( Version Number: 
V 2.1 , Version Date : September 27 , 2025 ) . 
 
Sponsor: Suzhou Yimufeng Biotechnology Co., Ltd. 
 
Name: 
 
sign: 
 
date: 
 
 
 
 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Plan version number / version date: V2.1 / September 27, 2025 
Page 19 4 NUMPAGES  
 
Description of major changes to the plan  
Solution 
version number 
Plan version date 
Main changes and reasons 
V1.0 
March 18, 2025 
not applicable. 
V1.1 
April 28, 2025 
1. 
The research background section of the protocol updates the 
results of the IMC002 Phase I/ IIa study; 
2. 
The inclusion criteria were increased to include "if the first-
line treatment used three drugs including taxanes (or 
anthracyclines), platinums and fluorouracils at the same 
time, and the disease progression was assessed by the 
researchers, the patient could also be included as an eligible 
subject." 
V1.2 
June 18, 2025 
Randomization stratification factors were modified according to 
changes in the treatment landscape. 
V2.0 
August 18, 2025 
1. 
Based on communication with the CDE, the original co-
primary endpoints of ORR and PFS were changed to a 
single endpoint of PFS; 
2. 
Considering the changes in clinical practice, multiple PD-
1/PD-L1 inhibitors have been approved as first-line and 
second-line drugs for advanced gastric cancer, and 
nivolumab has been removed from the comparator drug 
selection; 
3. 
Based on the requirement of at least 100 cases in the CDE 
trial group, the sample size calculation was adjusted from 
105 to 150 cases; 
4. 
PFS2 was deleted as an exploratory endpoint; 
5. 
Improved the description of the objectives and endpoints of 
the translational medicine section of the exploratory 
indicators; 
6. 
Added descriptions of companion diagnostics; 
7. 
Added life scale measurement; 
8. 
Increase the possible adverse reactions and treatment of 
control drugs. 

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V2.1 
September 27, 2025 
1. 
The inclusion criteria include the addition of intolerance 
criteria, the addition of dose adjustments of control drugs 
due to safety reasons and the discontinuation of treatment 
due to intolerance. 
2. 
In the bridging therapy and control drug section, add the 
selection of marketed drugs with gastric cancer indications 
or recommended by guidelines. 
3. 
It is clear that the number of subjects in the experimental 
group is no less than 100. 
4. 
According to the CDE's opinion, OS was selected as the key 
secondary endpoint, and OS-related sample size calculation 
was performed; relevant descriptions of the interim analysis 
were added. 
5. 
After the disease progresses in the control group, patients 
have the right to choose subsequent salvage treatment that 
is in their own interests. 
 
Head record 
PRINCIPAL INVESTIGATOR'S PROTOCOL SIGNATURE PAGE  .............................. 2 
SPONSOR'S PROPOSAL SIGNATURE PAGE  .................................................................. 3 
DESCRIPTION OF MAJOR CHANGES TO THE PLAN  ................................................. 4 
PROJECT SUMMARY  ......................................................................................................... 11 
ABBREVIATIONS  ................................................................................................................. 31 
1. PREFACE  ........................................................................................................................... 33 
1.1 DISEASE BACKGROUND  .................................................................................................... 33 
1.2 IMC002 PRECLINICAL STUDY RESULTS  ........................................................................... 37 
1.2.1 OVERVIEW OF IMC002 PRECLINICAL STUDIES  ....................................... 37 
1.2.2 IMC002 EXISTING PRECLINICAL RESEARCH DATA  ............................... 38 
1.3 RESULTS OF IMC002 EARLY CLINICAL STUDIES  ............................................................. 41 
1.4 RISKS AND BENEFITS  ........................................................................................................ 43 
1.5 DOSAGE SELECTION BASED ON  ......................................................................................... 45 
2. STUDY OBJECTIVES, STUDY ENDPOINTS AND ESTIMATED TARGETS  ........ 46 
2.1 RESEARCH OBJECTIVES  .................................................................................................... 46 
2.2 STUDY ENDPOINTS  ........................................................................................................... 47 

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2.3 ESTIMATED TARGET  ......................................................................................................... 48 
2.3.1 MAIN ESTIMATION TARGETS  ...................................................................... 48 
3. RESEARCH DESIGN  ........................................................................................................ 50 
3.1 OVERVIEW OF RESEARCH DESIGN  .................................................................................... 50 
3.2 RANDOM METHODS  ......................................................................................................... 52 
3.3 RESEARCH METHODS  ....................................................................................................... 53 
3.3.1 MOLECULAR PRE-SCREENING PHASE  ....................................................... 53 
3.3.2 SCREENING PERIOD  ....................................................................................... 53 
3.3.3 TREATMENT PERIOD  ...................................................................................... 53 
3.3.4 FOLLOW-UP PERIOD  ....................................................................................... 58 
3.4 STUDY SUSPENSION, TERMINATION AND WITHDRAWAL  .................................................. 59 
3.4.1 STUDY SUSPENSION AND TERMINATION  ................................................ 59 
3.4.2 TERMINATION OF STUDY TREATMENT  .................................................... 59 
3.4.3 EXIT STUDY  ...................................................................................................... 60 
3.4.4 LOST TO FOLLOW-UP  ..................................................................................... 61 
4. STUDY POPULATION  ..................................................................................................... 61 
4.1 SELECTION CRITERIA  ....................................................................................................... 61 
4.2 EXCLUSION CRITERIA  ....................................................................................................... 63 
4.3 REASSESSMENT OF SUBJECTS BEFORE APHERESIS  ............................................................. 66 
4.4 PRE-DOSE EVALUATION OF SUBJECTS FOR LYMPHOPROLIFERATIVE PRETREATMENT  ........ 67 
4.5 SUBJECT PRE-INFUSION ASSESSMENT  .............................................................................. 68 
4.6 REVIEW AND RESCREENING  ............................................................................................. 68 
5. RESEARCH THERAPEUTIC DRUGS  ........................................................................... 69 
5.1 BASIC INFORMATION OF STUDY DRUG  ............................................................................. 69 
5.2 PACKAGING AND LABELING  ............................................................................................. 69 
5.2.1 INVESTIGATIONAL DRUG IMC002  .............................................................. 69 
5.2.2 BRIDGING DRUGS, LYMPHOPROLIFERATIVE PRETREATMENT DRUGS, 
AND CRS TREATMENT DRUGS  ..................................................................................... 69 
5.3 DOSAGE OF THE DRUG ................................................................................................. 69 
 

Protocol Number: IMC002-RT02-RCT 
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Project Summary 
Protocol Name: A multicenter, randomized, controlled, open-label, Phase III confirmatory 
clinical study comparing the efficacy and safety of IMC002 with investigator's choice of therapy 
in adult subjects with inoperable locally advanced or metastatic gastric or gastroesophageal 
junction adenocarcinoma who have received at least two prior lines of therapy and are positive 
for CLDN18.2 expression. 
Protocol number: IMC002-RT0 2-RCT 
Version number and date: V2.1 , September 27, 2025 
Research phase : Phase III clinical study 
Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd. 
Research centers: approximately 30 
Study drug: Autologous CAR-T cell injection targeting CLDN18.2 (hereinafter referred to as 
CLDN18.2 CAR-T cells or CAR-T cells , codenamed IMC002), specification: 30 mL/bag. 
Subject population: Adult subjects with inoperable locally advanced or metastatic gastric or 
gastroesophageal junction adenocarcinoma who are positive for CLDN18.2 expression . 
Number of cases: Approximately 150 
Study objectives and endpoints: 
Research objectives: 
 
Main Purpose: 
To evaluate the progression-free survival (PFS) of IMC002 compared with investigator's 
choice of therapy (ICT) as third-line or higher-line treatment for inoperable locally advanced or 
metastatic gastric or gastroesophageal junction adenocarcinoma that is CLDN18.2 positive . 
 
Secondary objectives: 
1) To evaluate the efficacy of IMC002 compared with ICT as a third-line or higher 
treatment for inoperable locally advanced or metastatic gastric or gastroesophageal 
junction adenocarcinoma that is positive for CLDN18.2 . 
2) Describe the security features of IMC002 . 
3) Cell kinetics were evaluated in subjects infused with IMC002. 
 
Exploratory purpose: 

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1) be conducted including immunogenicity analysis, lentiviral insertion site analysis, and 
replication-competent lentivirus ( RCL). 
2) To evaluate the changes in cytokines before and after administration of IMC002 and 
their correlation with efficacy and safety. 
3) To evaluate the correlation between biomarker changes before and after IMC002 
administration and its efficacy and safety. 
4) To evaluate the phenotypic changes of CAR-T cells before and after IMC002 
administration. 
5) To evaluate the correlation between changes in the tumor microenvironment of tumor 
tissue samples before and after IMC002 administration and its efficacy and safety. 
6) To evaluate the effectiveness of subsequent IMC002 treatment in subjects in the control 
group. 
7) To evaluate the effects of IMC002 and ICT on the quality of life of subjects. 
Study endpoints: 
 
Primary study endpoint: 
Progression-free survival (PFS) assessed by a blinded independent imaging review 
committee (BIRC). 
 
Key secondary study endpoints: 
Overall survival (OS). 
 
Secondary endpoints: 
1) Based on investigator-assessed PFS, objective response rate (ORR), disease control 
rate ( DCR ) , duration of response ( DOR ), and time to response (TTR) based on 
BIRC and investigator evaluation . 
2) According to NCI CTCAE 5.0 ( except CRS /ICANS , according to 2019 ASTCT CRS 
/ICANS grading criteria were used to evaluate the type, frequency, and severity of 
treatment -emergent adverse events (TEAEs) and treatment- related adverse events 
(TRAEs) , as well as changes in laboratory values, vital signs, and ECG. 
3) Cell kinetic indicators include analysis of the number of CAR-T cells and CAR copy 
number in peripheral blood : such as C max , T max , AUC, C last , T last , C max /T max , and 
maximum survival time. 
 
Exploratory endpoints: 
1) ADA immunogenicity analysis, lentivirus insertion site analysis, and replication-
competent lentivirus (RCL) detection were performed. 

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2) cytokines (such as IL-2, IL-6, TNF - α, INF-γ, etc.) before and after IMC002 
administration were detected. 
3) Additional exploratory testing may be conducted in research centers with appropriate 
conditions to support the evaluation of changes in biomarkers (such as CLDN18.2, 
etc.) before and after administration of IMC002. 
4) Additional exploratory testing can be performed at research centers with appropriate 
conditions to support the evaluation of changes in CAR-T cell phenotype before and 
after IMC002 administration (at time points with CAR-T expansion, such as if there 
are surplus samples ). 
5) In research centers with corresponding conditions, additional exploratory tests can be 
carried out to support the CAR-T expansion, immune cell composition (CD4+/CD8+ 
ratio, memory cell phenotype, etc.) and changes in patient tumor tissues. 
6) subsequent IMC002 treatment for subjects in the control group, including ORR , etc. 
7) The European Organisation for Research and Treatment of Cancer (EORTC) 
quality of life scale was used to assess the subjects' quality of life . 
 
Study Design: 
This study is a multicenter, randomized, active-controlled, open-label, confirmatory clinical 
study to evaluate the efficacy and safety of IMC002 compared with ICT as third-line or higher-
line treatment for subjects with advanced gastric/esophagogastric junction adenocarcinoma who 
are positive for CLDN18.2 expression . 
Subjects meeting the eligibility criteria will be randomly assigned to either the experimental 
or control group in a 2 :1 ratio. Following randomization, subjects in the experimental group will 
undergo peripheral blood mononuclear cell (PBMC) collection (abbreviated as apheresis), 
bridging therapy (if necessary), lymphoproliferative conditioning (abbreviated as CLEA), and a 
single infusion of IMC002. Subjects in the control group will undergo apheresis and ICT 
treatment until intolerable toxicity, progressive disease (PD), initiation of new anticancer 
therapy, or death. In the control group, if PD or intolerable toxicity develops after ICT treatment, 
eligible subjects, after full evaluation by the investigator, may receive CLEA and IMC002 
treatment. 
Randomization stratification factors included: 
 
Eastern Cooperative Oncology Group performance status (ECOG PS): 0 or 1 
 
Liver metastasis: yes or no 
 
Previous lines of systemic therapy: 2 lines * or ≥3 lines 
* Patients who received only first-line treatment with a combination of taxanes (or anthracyclines), 
platinums, and fluorouracils and whose disease progressed as assessed by the investigator were considered to 

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have failed the second-line regimen. 
Both groups of subjects will undergo relevant examinations according to the established 
visits in the trial flow chart to evaluate their efficacy, safety and cell dynamics. 
A BIRC will be established in this study to evaluate the tumor status and treatment response 
of the subjects according to the BIRC charter. 
An independent data monitoring committee (IDMC) has been established for this study, 
which will dynamically evaluate the clinical trial data in accordance with the IDMC charter 
requirements to assess the drug's efficacy, safety, and trial execution. 
In this study, the protein expression level of Claudin18.2 will be detected in the central 
laboratory using the cell tight junction protein (Claudin) 18.2 antibody reagent 
(immunohistochemistry method) companion diagnostic kit. 
Study population: 
Subjects must meet all the following inclusion criteria and not all exclusion criteria to be 
enrolled. 
Inclusion criteria 
1. 
The age at randomization was at least 18 years old , and both men and women were eligible. 
2. 
histologically or cytologically confirmed inoperable locally advanced or metastatic gastric/ 
gastroesophageal junction adenocarcinoma who have failed at least two previous lines of 
therapy : 
a. Radiographic progression or clinical worsening of symptoms during second-line 
treatment ( if first-line treatment includes three drugs including taxanes [or anthracyclines], 
platinums, and fluorouracils, and the disease progression is assessed by the investigator, the 
patient may also be enrolled as an eligible subject; disease progression within 6 months after 
the end of neoadjuvant/adjuvant treatment is also considered a first-line treatment failure). 
b. Patients with intolerance to second-line treatment may also be enrolled in the study after 
full evaluation by the investigator. The definition of intolerance to previous treatment is as 
follows: 
 
any Grade ≥ 3 (according to NCI CTCAE v5.0 criteria) hematologic toxicity that 
has not recovered to Grade 1 or pre-treatment levels after 14 days of best supportive 
care; 
 
any Grade ≥ 3 (according to NCI CTCAE v5.0 criteria) non-hematologic toxicity 
(excluding alopecia and asymptomatic laboratory abnormalities) that has not 
resolved after 14 days of best supportive care. 
3. 
Tumor tissue specimens (primary or metastatic, archived or newly collected) from subjects 

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are expected to be available and tested by a central laboratory, indicating positive 
histological staining for CLDN18.2 (defined as a positive tumor cell rate ≥40% and a 
staining intensity ≥2+) . If the subject has previously received other CLDN18.2-targeted 
therapies, tumor tissue specimens collected after that treatment are required to retest and 
evaluate CLDN18.2 expression levels . 
4. 
The subject's expected survival period is ≥12 weeks. 
5. 
According to the RECIST 1.1 standard, there must be at least one stably measurable target 
lesion or evaluable lesion, and the longest diameter of the largest lesion (or the shortest 
diameter if it is a lymph node lesion) should be ≤5 cm . 
6. 
ECOG performance status score is 0-1. 
7. 
The subject must have adequate organ and bone marrow function. Laboratory screening 
must meet the following criteria. All laboratory test results should be within the stable ranges 
described below, and there should be no ongoing supportive treatment. If any laboratory test 
result is abnormal based on the following criteria , the test can be repeated within 1 week. 
If the test results still do not meet the following criteria , the patient has failed the screening. 
a) Blood tests [no enhanced blood transfusion ( ≥ 2 times within 1 week), platelet 
transfusion, or cell growth factor (except recombinant erythropoietin) within 7 days 
before the examination]: neutrophil count ≥ 1.5×10 9 /L; platelet count (PLT) ≥ 75×10 
9 /L; hemoglobin content (Hb) ≥ 8.0g/dL; lymphocyte (LYM) ≥ 0.5×10 9 /L; 
b) Liver 
function: 
alanine 
aminotransferase 
(ALT) 
≤ 
2.5×ULN, 
aspartate 
aminotransferase (AST) ≤ 2.5×ULN, serum total bilirubin (TB) ≤ 2×ULN; for patients 
with liver metastasis, AST and ALT < 5×ULN; 
c) Renal function: Serum creatinine ≤ 1.5 × ULN. If serum creatinine is > 1.5 × ULN, 
creatinine clearance > 50 mL/min (according to the Cockcroft-Gault formula); 
qualitative urine protein ≤ 1+; if qualitative urine protein is ≥ 2+, a 24-hour urine protein 
quantitative test is required (a 24-hour urine protein quantitative test < 1 g is 
acceptable); 
d) Amylase and lipase ≤ 1.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN. For 
patients with bone metastases, ALP < 5 × ULN. 
8. 
All toxic reactions caused by previous anti-tumor therapy have been alleviated to Grade 0-
1 (according to NCI CTCAE Version 5.0) or to a level acceptable to the inclusion/exclusion 
criteria. This excludes other toxicities such as alopecia and vitiligo that the investigator 
believes do not pose a safety risk to the subjects. 
9. 
Reproductive status: Female patients of childbearing age or male patients whose sexual 
partners are female patients of childbearing age are willing to take medically approved and 
highly effective contraceptive measures , such as intrauterine devices or condoms, from the 

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time the informed consent is signed until 12 months after cell infusion (female patients of 
childbearing age include premenopausal women and women within 24 months of 
postmenopause). 
10. The subjects must sign and date the written informed consent form. 
11. Subjects must be willing and able to comply with the scheduled treatment regimen, 
laboratory tests, follow-up and other study requirements. 
Exclusion criteria 
Subjects who meet any of the following conditions will not be included in this study; 
1. 
Pregnant and breastfeeding women. 
2. 
Positive human immunodeficiency virus (HIV) antibody; hepatitis B virus infection 
(HBsAg positive and/or HBc antibody positive, and HBV-DNA positive ); acute or chronic 
active hepatitis C (HCV antibody positive and HCV-RNA positive ); positive syphilis 
antibody; Epstein-Barr virus infection (IgM positive); cytomegalovirus (CMV) infection 
(IgM positive) ; positive human T- lymphotropic virus ( HTLV ); positive for novel 
coronavirus (COVID-19) and not reverting to negative within 7 days . The above pathogen 
test results are subject to the central laboratory test results. 
3. 
Known HER2 expression is positive (defined as IHC 3+, or IHC 2+ and FISH+). 
4. 
Active or clinically poorly controlled serious infection. 
5. 
Patients had uncontrollable pleural effusion, pericardial effusion, and ascites before 
enrollment. 
6. 
Extensive or diffuse lung metastases or extensive or diffuse liver metastases or extensive or 
diffuse bone metastases . 
7. 
Blood oxygen saturation is ≤ 95% without oxygen inhalation. 
8. 
Other serious pulmonary diseases that may limit their participation in this study, such as 
pulmonary embolism, chronic obstructive pulmonary disease, symptomatic or poorly 
controlled interstitial lung disease, or clinically significant abnormalities in pulmonary 
function tests. 
9. 
Patients with deep and large ulcers of the primary lesion, or recurrence of the anastomotic 
site with tumor infiltration of the entire layer, or tumor lesions infiltrating large blood 
vessels, who are judged by the researchers to be at high risk of bleeding or perforation, were 
included in the CT/MRI or combined gastroscopy examinations. 
10. Patients with known past or current hepatic encephalopathy requiring treatment; patients 
with current or history of central nervous system diseases, such as epileptic seizures, 
cerebral ischemia /hemorrhage, dementia, cerebellar disease, or any autoimmune disease 
involving the central nervous system; patients with central nervous system metastasis or 

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meningeal metastasis who are judged by the investigator to be unsuitable for inclusion. 
11. unstable heart disease that requires treatment or heart disease that cannot be controlled after 
treatment, or hypertension that is poorly controlled as determined by the researchers 
(defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure > 100 
mmHg after standard antihypertensive drug treatment); or diabetes that is still poorly 
controlled after standard treatment (fasting blood glucose ≥ 10.2 mmol/L). 
12. Any of the following cardiac clinical symptoms or diseases within 6 months before cell 
infusion: 
a) Left ventricular ejection fraction (LVEF) < 50%; 
b) Myocardial infarction within 1 year; or unstable angina; or history of percutaneous 
coronary intervention (PCI) or coronary artery bypass grafting (CABG); use of 
pacemaker; 
c) Resting electrocardiogram (ECG) with QTc F >450 ms (male) or QTc F >470 ms 
(female); 
d) Resting electrocardiogram reveals clinically significant abnormalities (such as 
abnormalities in heart rate, conduction, or morphological characteristics), complete left 
bundle branch block, third- degree atrioventricular block, or a PR interval greater than 
250 ms. 
13. Evidence of a significant coagulopathy or other significant bleeding risk, including: 
a) clinically significant coagulation abnormalities; 
b) A history of intracranial hemorrhage or spinal cord hemorrhage; 
c) Patients whose tumor lesions invade large blood vessels and have a significant risk of 
bleeding; 
d) Patients with current unstable or active ulcers or active gastrointestinal bleeding; 
e) An embolic event occurred within 6 months before cell transfusion; 
f) 
Clinically significant hemoptysis or significant bleeding in tumor lesions occurred 
within 1 month before cell transfusion; 
g) Major trauma or major surgery within 1 month before enrollment; 
h) The presence of any bleeding disorders, such as hemophilia, von Willebrand disease, 
etc.; 
i) 
Use of anticoagulant therapy (except low molecular weight heparin) for therapeutic 
purposes within 2 weeks before cell transfusion; 
j) 
Patients are currently receiving conventional anticoagulant therapy (such as warfarin 
or heparin). Patients require long-term antiplatelet therapy (aspirin ≥ 100 mg/day; 

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clopidogrel ≥ 75 mg/day); dipyridamole, ticlopidine, or cilostazol. 
14. Receipt of systemic steroids equivalent to >15 mg/day of prednisone for more than 3 days 
within 2 weeks before apheresis, excluding inhaled steroids. 
15. Subjects requiring systemic treatment with corticosteroids or other immunosuppressive 
drugs during treatment. Subjects with any active autoimmune disease, or a history of 
autoimmune disease with expected recurrence (including but not limited to systemic lupus 
erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel 
disease, and asthma requiring medical intervention with bronchodilators). Exceptions 
include: type 1 diabetes; skin diseases not requiring systemic treatment (e.g., vitiligo, 
psoriasis); alopecia; hypothyroidism requiring only hormone replacement therapy; asthma 
that fully resolved in childhood and does not require any intervention in adulthood; or other 
subjects whose condition is not expected to relapse in the absence of external triggers. 
16. Patients with previous or concurrent malignancies, with the following exceptions: 
a) Adequately treated basal cell or squamous cell carcinoma of the skin (adequate wound 
healing was required before study enrollment); 
b) Carcinoma in situ of cervical or breast cancer who has undergone curative treatment 
and has no signs of recurrence for at least 3 years before the study; 
c) The primary malignancy has been completely resected and remains in complete 
remission for ≥ 5 years. 
17. Subjects who have previously received other gene therapies, including but not limited to 
CAR-T therapy and TCR-T therapy . 
18. Received the following treatments or drugs before cell infusion: received chemotherapy, 
targeted therapy, biological therapy, endocrine therapy, immunotherapy and other anti-
tumor treatments (except for treatments used in accordance with the protocol requirements 
before infusion, such as lymphoproliferative conditioning and bridging therapy) , less than 
28 days or less than 5 half-lives (whichever is shorter) from the first infusion of treatment 
in this study ; received traditional Chinese medicine treatment with anti-tumor indications 
within 2 weeks before cell infusion. 
19. There is a history of other severe allergies such as anaphylactic shock. 
20. Subjects with severe mental disorders. 
21. If a subject develops a new arrhythmia, including but not limited to arrhythmias that cannot 
be controlled with medication; hypotension requiring pressor medication; or bacterial, 
fungal, or viral infection requiring intravenous antibiotics , the investigator may determine 
that the subject is unsuitable for participation in the trial . Subjects who are taking antibiotics 
to prevent infection may continue to participate in the trial at the investigator's discretion. 
22. Participation in other interventional clinical studies and use of study drug within 1 month 

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before the planned IMC 002 infusion . 
23. The investigator assesses that the subject is unable or unwilling to comply with the 
requirements of the study protocol. 
24. 4 weeks before the planned apheresis time or plan to receive a live attenuated vaccine during 
the study. 
25. Subjects with gastrointestinal obstruction or obstructive jaundice are deemed unsuitable for 
participation in this trial by the investigator . 
26. Subjects with any other concurrent serious and/or uncontrolled medical conditions who are 
deemed unsuitable for participation in this trial by the investigator. 
Reassessment before apheresis 
Subjects who are confirmed to be qualified by screening examination can undergo 
leukocyte apheresis. 
Seven days before apheresis, the researcher needs to conduct relevant examinations (if the 
screening examination is no more than 7 days away from the apheresis, there is no need to re- 
examine, unless the researcher assesses that there are clear reasons that may cause the test values 
to change during this period). The patient should be re-evaluated and the subject must meet the 
following criteria: neutrophil count ≥ 1.5×10 9 /L; platelet count PLT ≥ 75×10 9 /L; 
hemoglobin content Hb ≥ 8.0 g/dL; lymphocyte LYM ≥ 0.5×10 9 /L. 
Evaluation before lympholysis pretreatment and IMC002 infusion 
Pre-treatment assessment of leaching 
If the subject meets any of the following criteria before lymphoproliferative pretreatment 
and is judged by the researcher to be unsuitable for subsequent trial procedures, 
lymphoproliferative pretreatment cannot be continued or needs to be delayed , and infusion 
cannot be performed or needs to be delayed. 
1. ECOG performance status score ≥2 points; 
2. Active infection: If the subject requires systemic anti-infective treatment or has a body 
temperature of ≥38 ° C within 7 days before lymph node clearance pretreatment, the 
investigator must discuss this with the sponsor before starting lymph node clearance 
pretreatment; 
3. Patients are assessed by the investigator to have a high risk of bleeding or perforation; 
4. with known or suspected central nervous system metastasis; 
5. Surgery, interventional therapy, radiotherapy or immunotherapy for the disease underwent 
within 2 weeks before lympholysis pretreatment; 
6. Blood test: Neutrophil count < 1.5×10 9 /L; Platelet count (PLT) < 75×10 9 /L; Hemoglobin 

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content (Hb) < 8.0 g/dL; 
7. Liver function: Alanine aminotransferase (ALT) > 2.5×ULN, aspartate aminotransferase 
(AST) > 2.5×ULN, serum total bilirubin (TB) > 2×ULN; for patients with liver metastasis, AST 
and ALT > 5×ULN; 
8. Renal function: Creatinine clearance < 50 mL/min (according to the Cockcroft-Gault 
formula); 
9. Amylase and lipase > 1.5 × ULN; alkaline phosphatase (ALP) > 2.5 × ULN; for patients 
with bone metastases, ALP > 5 × ULN ; 
10. international normalized ratio (INR) and partial prothrombin time (APTT) > 1.5 × ULN; 
11. Oxygen supplementation is required to maintain blood oxygen saturation > 95% (referring 
to pulse oxygen) 
12. Patients who have used systemic glucocorticoids within 7 days before lymph node clearance 
pretreatment and whose cumulative dose exceeds 70 mg of prednisone (except those who used 
inhaled or topical glucocorticoids); 
13. Any toxic reactions caused by bridging therapy have not recovered to CTCAE grade 2 or 
below; 
14. failure to complete the bridging therapy washout period; 
15. Other complications or toxicities may place the subject at inappropriate risk for 
lymphoproliferative conditioning and IMC002 cell infusion, including but not limited to the 
development of new arrhythmias in the subject that cannot be controlled by medication; 
hypotension requiring pressors; the researcher assesses the patient's presence of major organ 
dysfunction ( such as severe heart disease, uncontrolled hypertension or diabetes, severe liver or 
kidney damage, pulmonary edema, severe lung infection, brain metastasis, etc. ). If necessary, it 
is recommended to discuss the matter with the sponsor's medical department. 
IMC002 Pre-infusion Assessment 
Before IMC002 infusion, the subject's clinical status should not be significantly worse than 
that at the time of enrollment screening as assessed by the investigator, which would increase 
the risk of IMC002 infusion. On the scheduled IMC002 infusion day, if the subject meets any of 
the following criteria, IMC002 infusion should be delayed: 
1. ECOG performance status score ≥ 2 
2. Active infection: If the subject requires systemic anti-infection treatment or has a body 
temperature ≥38°C, the infusion cannot be given or needs to be delayed; 
3. CTCAE grade 3 or higher non-hematologic toxicity (excluding grade 3 nausea, vomiting, 
diarrhea, or constipation) occurring after lympholysis pretreatment; 

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4. Oxygen supplementation is required to maintain blood oxygen saturation > 95% (referring 
to pulse oxygen); 
5. Other complications or toxicities may place the subject at inappropriate risk for IMC002 
cell infusion, including but not limited to the subject experiencing new arrhythmias that cannot 
be controlled by medication; hypotension requiring pressors; the researcher assesses the patient 
to have major organ dysfunction ( such as severe heart disease, uncontrolled hypertension or 
diabetes, severe liver or kidney damage, pulmonary edema, severe lung infection, brain 
metastasis, etc. ). If necessary, it is recommended to discuss the medical situation with the 
sponsor. 
For subjects who have completed cell preparation but do not meet the reinfusion criteria 
and need to delay infusion, if their body temperature does not return to normal within 7 days 
after the lymphatic ablation pretreatment or other toxicity does not recover to ≤ Grade 1, the 
investigator will evaluate whether the subject should receive another lymphatic ablation 
pretreatment. If for any reason the cell infusion is delayed for more than 7 days after the 
lymphatic ablation pretreatment, the infusion cannot be performed , or the investigator will 
evaluate whether the subject should receive another lymphatic ablation pretreatment to delay the 
infusion. It is recommended that the interval between two lymphatic ablations be no less than 4 
weeks . 
Treatment 
 
experimental group 
Trial interventions and treatments : including apheresis, bridging therapy (if necessary), 
lymphoblastic leukorrhea clearance, and IMC002 infusion. 
After randomization , the subjects will begin apheresis. Before apheresis and 
lymphoproliferative pretreatment, the researchers will judge the subject's status and consider 
bridging therapy based on the subject's clinical benefits and risks. The purpose of bridging 
therapy is to stabilize the subject's current disease status or reduce the subject's current tumor 
burden. The preferred drugs are those with gastric cancer indications in the instructions, or after 
the researchers combine clinical practice and the patient's previous medication status, irinotecan 
monotherapy can be used for 1-2 courses (recommended dose: irinotecan 150 mg/m 2 , 
intravenous drip, single dose) or FOLFIRI regimen (recommended dose: irinotecan 130-150 
mg/m 2 , 5-fluorouracil 2400 mg/m 2 , intravenous drip, single dose) or paclitaxel (recommended 
dose: paclitaxel 135 mg/ m² , intravenous infusion, single dose) as bridging therapy. The use of 
bridging therapies other than the recommended regimen requires medical confirmation from the 
investigator and the sponsor. Bridging therapy must be completed 7 days prior to 
lymphoproliferative conditioning , or a washout period of at least five half-lives of the bridging 
agent from the time of lymphoproliferative conditioning (whichever is longer) . Once the 
IMC002 product has been prepared and meets the inspection and release specifications, and if 

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the subject meets the cell reinfusion criteria, IMC002 cell infusion can be performed. Subjects 
will receive a single infusion of two bags of IMC002 , for a total dose of 2.5×10⁸ CAR -T cells per 
subject. 
Lymphocyte depletion pretreatment: This is lymphocyte depletion chemotherapy. This 
pretreatment is performed before IMC002 infusion to increase T cell counts and survival in vivo. 
Each subject will receive lymphocyte depletion pretreatment according to the following regimen 
before cell infusion. The specific dosage can be adjusted at the investigator's discretion. The 
lymphocyte depletion pretreatment regimen consists of fludarabine, cyclophosphamide, and 
nab-paclitaxel (FNC) . If a subject is allergic to or intolerant of nab-paclitaxel, the investigator 
may administer fludarabine combined with cyclophosphamide (FC), depending on the subject's 
condition. 
(1) FNC regimen: Fludarabine (F) combined with cyclophosphamide (C) + albumin-
paclitaxel (N) regimen 
Fludarabine 25 mg/m 2 /day × 2 days (day 1 and day 2 for clearing urethritis) 
Cyclophosphamide 250 mg/m 2 /day × 3 days (lymph clearance on the first, second, and 
third days) 
nab-paclitaxel 100 mg (2nd day after clearing stranguria) 
If the subject is allergic to or intolerant to albumin-paclitaxel, the researcher may choose 
the following FC lympholysis pretreatment regimen based on the subject's condition. 
(2) FC regimen: Fludarabine combined with cyclophosphamide 
Fludarabine 20-25 mg/m 2 /day × 2 days 
Cyclophosphamide 500 mg/m 2 /day × 2 days 
The body surface area of the subjects was calculated according to the Stevenson formula: 
Body surface area (m 2 ) = 0.0061 × height (cm) + 0.0128 × weight (kg) - 0.1529 
If the researcher needs to use a lymphoproliferative conditioning regimen for a subject 
beyond the protocol, this should be discussed with the sponsor. CAR-T cell infusion can begin 
1-2 days after the subject has received the lymphoproliferative conditioning regimen. 
IMC002 Infusion : Subjects who have successfully prepared the IMC002 injection and have 
undergone lymphoproliferative pretreatment and are assessed by the investigator as eligible will 
continue to receive the IMC002 infusion . Prior to cell infusion, sufficient backup medications 
(e.g., at least two doses of tocilizumab) should be available, and emergency facilities and 
equipment should be readily available for prompt treatment in the event of a severe allergic 
reaction, severe hypotension, or other emergency. Thirty to sixty minutes before cell infusion, 
investigators may consider pre-treating subjects to prevent infusion reactions based on clinical 
experience , such as with histamines such as acetaminophen (300-1000 mg orally), promethazine 

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hydrochloride (25 mg intramuscularly), or diphenhydramine (50 mg). Following infusion, each 
subject is recommended to remain hospitalized for 14 days, or the investigator may determine 
the time of discharge based on the subject's condition . 
 
Control group: 
After randomization, subjects will undergo single-dose sampling before receiving the 
investigator's selected treatment. Comparator drugs include apatinib mesylate, paclitaxel alone, 
docetaxel alone, or irinotecan alone. Drugs with gastric cancer indications in the package insert 
are preferred, or selected by the investigator based on clinical experience and the patient's 
previous medication history. Dose adjustments are permitted based on the subject's tolerance. 
This continues until toxic intolerance, disease progression, initiation of new anti-cancer therapy, 
or death, whichever occurs first. The trial center is responsible for drug storage and distribution, 
and the investigator will conduct safety and efficacy assessments on the subjects according to 
the established visits. 
Apatinib mesylate: 850 mg, orally, once a day. 
Paclitaxel alone: Paclitaxel 80 mg/m 2 , intravenous drip, on day 1, day 8, day 15, and repeat 
every 28 days. 
Docetaxel alone: docetaxel 75-100 mg/m 2 , intravenous drip, on day 1, repeated every 21 
days. 
Irinotecan monotherapy: 150-180 mg/m 2 by intravenous drip on day 1, repeated every 14 
days. 
For subjects in the control group who have undergone apheresis and successfully prepared 
IMC002, if they develop PD or toxic intolerance after receiving ICT drug treatment, the 
researcher, after fully evaluating the subject's overall condition, believes that subsequent 
treatment with IMC002 is in the best interest of the subject and may recommend that the subject 
consider subsequent treatment with IMC002. Patients also have the right to choose subsequent 
salvage treatment that is in their best interests. If the subject is willing to receive this product, a 
further assessment of their condition before lymphoblastic leukemia and IMC002 cell infusion 
will be required, using the same assessment criteria as the experimental group. Those who meet 
the assessment criteria can begin the lymphoblastic leukemia and IMC002 treatment process, 
using the same treatment plan as the experimental group. 
Research Assessment 
Safety will be assessed by adverse events, ECOG performance status score , vital sign 
measurements, physical examination results , laboratory test results , electrocardiogram , and 
echocardiogram . 
Tumor assessments will be conducted by the BIRC and the investigator according to 
RECIST 1.1 criteria . Starting from post-randomization apheresis, the first tumor assessment will 

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be conducted at week 8 ± 7 days (for the IMC002 trial group, this must also be at least 4 weeks 
post-infusion). Tumor assessments will be conducted every 6 weeks ± 7 days thereafter until 
disease progression, as determined by the investigator and confirmed by the BIRC , initiation of 
new anti-cancer therapy, death, loss to follow-up, or study withdrawal, whichever occurs first. 
For patients in the control group who receive IMC002 infusion after progression, the first post-
infusion tumor assessment will be conducted at week 4 ± 2 days post-infusion. Tumor 
assessments will be conducted every 6 weeks ± 7 days thereafter until disease progression, as 
determined by the investigator, initiation of new anti-cancer therapy, death, loss to follow-up, or 
study withdrawal, whichever occurs first. 
Survival status was collected every 12 weeks after entering the survival follow-up. 
Tissue, blood, and serum samples will be collected from the subjects to evaluate 
characteristic information such as the expression ratio and intensity of the CLDN18.2 target, 
changes in biomarkers related to the tumor immune microenvironment characteristics and the 
body's overall immune characteristics, and cytokine level analysis, IMC002 cell dynamics, and 
immunogenicity analysis will be performed. 
Sample size and statistical methods 
Sample size: 
This study used BIRC-assessed PFS as the primary endpoint. Early study data indicate that 
the median PFS (mPFS) observed in the IMC002 trial arm is approximately 6.9 months, while 
historical data indicate that the mPFS in the control arm (investigator's choice of treatment) 
ranges from 1.6 to 2.6 months. This study assumed mPFS of 5.2 and 2.6 months in the trial and 
control arms, respectively, and a true PFS hazard ratio ( HR: IMC002 vs. investigator's choice 
of treatment) of 0.5. With a power of 85%, a one-sided type I error rate of 0.025, and a 2:1 
randomization ratio between the trial and control arms , the final analysis required approximately 
86 events. 
Assuming complete enrollment within 12 months, the minimum follow-up is 3 months . 
The sample size was also calculated based on the key secondary endpoint of OS . Assuming 
an exponential distribution for OS, the median OS in the control group was approximately 6 
months, and the true OS hazard ratio (HR: IMC002 vs. investigator-selected treatment) was 0.56. 
OS will be tested at a one-sided 0.025 test level. With an assumed power of 80 % , the final 
analysis of OS will be conducted approximately 10 months after the last randomized subject, 
when approximately 112 events have been observed. 
Considering a 20% dropout rate, approximately 150 subjects need to be enrolled. The trial 
group should enroll at least 100 subjects. 
Interim analysis: 

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The interim analysis of OS will be conducted at the same time as the final analysis of PFS . 
The O'Brien-Fleming spending function (Lan-Demets algorithm) will be used to calculate the 
significance level for both the interim and final analyses of OS. Gate keeping will be used to 
control type I error. Hypothesis testing for the key secondary endpoint of OS will only be 
conducted if the hypothesis test for the primary endpoint of PFS is significant . 
Analysis set: 
Intention-to-treat (ITT) analysis set included all randomized subjects. 
Modified intention-to-treat analysis set (mITT): all subjects who were randomized and 
received at least one dose of study treatment (IMC002 or ICT). 
Per-Protocol Set (PP): Subjects in the ITT set who did not experience major protocol 
violations that affected the efficacy evaluation and who had at least one efficacy evaluation. 
Major protocol violations that affected the efficacy evaluation will be determined after 
discussion in the blind review meeting before the database is locked. 
Safety Analysis Set ( SS ): includes all subjects who were randomized and received at least 
one dose of study treatment. Subjects will be analyzed based on the study treatment they received 
(IMC002 or ICT). 
Cell Kinetics Set ( PKS ): All subjects who received IMC002 cell infusion, had at least one 
valid PK data, and did not experience protocol deviations that seriously affected the PK 
evaluation will be used for PK analysis. 
Pharmacodynamic analysis set: All subjects who received IMC002 cell infusion and had 
baseline and at least one post-baseline evaluable pharmacodynamic index examination results. 
Immunogenicity analysis set: All subjects who received IMC002 cell infusion and had at 
least one post-dose ADA result. This dataset was used for immunogenicity analysis. 
Crossover Analysis Set: The crossover analysis set includes subjects randomly assigned to 
the control group who crossed over to receive IMC002 cell infusion. All analyses of safety and 
efficacy parameters collected after subjects received crossover treatment were performed using 
this analysis set. 
Statistical analysis: 
Demographics and other baseline characteristics: 
will be summarized by treatment group using descriptive statistics in the ITT . Relevant 
medical history and current medical conditions at baseline will be summarized by system organ 
class and preferred term, as well as by treatment group. 
Efficacy analysis: 
Details of data processing, statistical methods, and result presentation will be described in 
detail in the Statistical Analysis Plan (SAP). The final version of the SAP will be finalized before 

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the database is locked. All statistical analyses will be performed using SAS version 9.4 or later. 
Generally, continuous variables will be described using the number of cases, mean, median, 
standard deviation, minimum, and maximum values; categorical and ordinal variables will be 
described using the frequency and percentage of each category or level. Time-to-event metrics 
will be analyzed separately using the Kaplan-Meier method. The median, 25th and 75th 
percentiles, and their 95% confidence intervals will be calculated for each cohort, and Kaplan-
Meier curves will be plotted. Unless otherwise specified, missing values will not be included in 
the calculation of percentages. 
The primary endpoint of this study was progression -free survival (PFS), as assessed by the 
BIRC. PFS was defined as the time from the date of randomization to the first documented 
disease progression (as assessed by the BIRC according to RECIST 1.1) or death from any 
cause . PFS analysis was based on the ITT dataset. If two or more consecutive tumor assessments 
were missed before the PFS event date, PFS was censored to the date of the last evaluable tumor 
assessment before the missed assessment . The Kaplan-Meier method was used to calculate the 
median PFS, quartiles, and 95% confidence intervals (CIs) for each group. Censorship was 
summarized, and KM curves were plotted. A stratified log-rank test was used to compare PFS 
between the two groups. A stratified proportional hazards regression model (the exact method 
was used for identical event times) was used to estimate the hazard ratio (HR) and 95% CI for 
the experimental group versus the control group. Stratification factors were used at 
randomization. Sensitivity analyses were also performed using data from the mITT and PP 
datasets. 
The primary estimated objective PFS analysis will take into account different concomitant 
events as follows: 
 
Discontinuation of study treatment: PFS analysis will take into account all tumor 
assessments and deaths, regardless of discontinuation of study treatment for any reason 
(treatment strategy) 
 
Patients who underwent a crossover (for patients in the control group) or started a new 
anticancer treatment (for all patients) were treated with a hypothetical strategy whereby 
PFS would be censored at the date of the last adequate assessment or the date of 
randomization before the crossover or start of new anticancer treatment if no PFS event 
was observed before the crossover or start of new anticancer treatment. 
 
Any unforeseen concomitant events, such as those arising from public health 
emergencies, will be addressed through therapeutic strategies. 
Treatment of missing values not related to concurrent events 
The censoring rules for PFS follow the RECIST 1.1 guidelines and will be further detailed 
in the statistical analysis plan (SAP). 
Sensitivity analysis  

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As a sensitivity analysis, the two treatment groups will be compared using a nonstratified 
log-rank test. A nonstratified Cox model will be used to generate the PFS hazard ratio and 95% 
confidence interval based on BIRC review. The sensitivity analysis estimates are the same as the 
key secondary estimates. Additional sensitivity analyses and estimates, if any, will be detailed in 
the SAP. 
Supporting analysis  
In the ITT, investigator-assessed PFS will be analyzed using a stratified Cox model, as in 
the primary efficacy analysis, and the treatment effect will be summarized as the hazard ratio 
with its 95% confidence interval. Kaplan-Meier curves, medians, and 95% confidence intervals 
will be provided for each treatment group. 
In the ITT, hazard ratios and 95% confidence intervals for PFS based on BIRC review will 
be obtained from stratified and covariate-adjusted Cox models including sex and age. The final 
list of covariates included in the model will be provided in SAP. 
If statistical significance is achieved in the primary analysis of PFS, subgroup analyses will 
be performed to assess the homogeneity of the treatment effect across demographics and baseline 
disease characteristics. Different thresholds or variables used for subgroup analyses will be 
detailed in the SAP. The number of subjects censored in the PFS analysis and the reasons for 
censoring will be summarized by treatment group. 
Analyses supporting secondary objectives 
Secondary efficacy endpoints will be assessed using ITT. 
The key secondary endpoint, OS, was defined as the interval from the date of randomization 
to the date of documented death from any cause. For subjects whose deaths were not 
documented, those who had not died by the analysis cutoff date were censored at the time of last 
contact. The analysis will be based on data from the ITT population. The OS analysis will provide 
Kaplan-Meier curves, medians, and 95% confidence intervals for OS in each treatment group . 
A stratified Cox model will be used to calculate the hazard ratio (HR) and its 95% confidence 
interval for OS .  
Disease control rate ( DCR ) is defined as the proportion of subjects who achieve BOR: 
CR , PR , SD , or non -CR/ non- PD . DCR will be analyzed using the same conventional analysis 
methods as ORR . 
ORR is defined as the proportion of subjects whose best overall response (BOR) is complete 
response (CR) or partial response (PR). The tumor response status was assessed by BIRC 
according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1). Confirmation must 
be made by repeated assessment at least 4 weeks after the CR and PR response criteria were first 
achieved. For ORR, the chi-square test or Fisher's exact test was used to compare the difference 
between the two groups, and the difference in ORR and its 95% confidence interval were 
calculated. The analysis was based on the ITT set and included all randomized subjects, 

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regardless of whether they complied with the protocol or withdrew from the trial. Stratified 
analysis can be performed to assess the difference in efficacy between different subgroups, in 
which the stratification factors used at the time of randomization were used. Sensitivity analysis 
was also performed on data based on the mITT and PP sets. 
Duration of response ( DOR ) was defined as the duration from the date of the first 
documented response ( CR or PR ) to the date of the first documented disease progression or all-
cause death. If a patient had no events, the DOR was censored at the date of the last adequate 
tumor assessment. Subjects whose BOR never achieved a CR or PR were excluded from the 
analysis. The Kaplan-Meier method was used to estimate the DOR distribution function. The 
median DOR and its 95% CI are presented by treatment group . 
Time to response ( TTR ), defined as the time from the date of randomization to the date of 
the first documented response ( CR or PR , which must then be confirmed), was analyzed 
descriptively. 
The above analyses will be performed based on BIRC assessment and local investigator 
assessment (according to RECIST 1.1 ). 
The BOR for each subject was determined in order of overall response according to the 
following rules : 
• CR = at least two CRs before disease progression , with at least 4 weeks between the two 
CRs . 
• PR = at least two PRs before disease progression , with at least 4 weeks between the two 
PRs (and not meeting CR criteria). 
• SD = SD in at least one assessment > 5 weeks after randomization (and does not meet 
CR or PR criteria).  
• Non- CR/ non- PD = non- CR/ non- PD in at least one assessment > 5 weeks after 
randomization (and does not meet CR , PR , or SD criteria). 
• PD = disease progression after randomization (and does not meet CR , PR , SD , or non- 
CR/ non- PD criteria). 
• Not evaluable = all other lesions (i.e., not meeting confirmed CR or PR criteria or non- 
CR/ non- PD after > 5 weeks and no SD , or no early progression) 
Analysis time point 
The final analysis of PFS efficacy will be performed approximately 3 months after 
completion of enrollment when at least 86 PFS events have been observed. The interim analysis 
of OS will be performed at the time of the final analysis of PFS. The final analysis of OS efficacy 
will be performed approximately 10 months after the last subject is randomized when at least 
112 deaths have been observed. 

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Security Analysis 
All listings and tables are presented by treatment group using the safety set. 
Exposure to each study drug was summarized descriptively, including the number of cycles 
received (number and percentage of patients), duration of exposure (days), total cumulative dose 
per patient, dose intensity, and relative dose intensity. 
Adverse events (AEs) were coded verbatim to Medical Dictionary for Drug Regulatory 
Activities (MedDRA ® ) terms according to NCI CTCAE 5.0 (except CRS and ICANS, which 
were coded according to 2019 ASTCT All treatment -emergent adverse events (TEAEs) were 
summarized . 
Identify outliers in clinical laboratory data. Selected laboratory data are summarized by 
level. Changes in vital signs are also summarized by visit number. 
Cell kinetic analysis 
This study will collect PK samples according to the evaluation plan. 
The main pharmacokinetic parameters of each subject were calculated using the non-
compartmental model of WinNonlin 8.2 (or newer version) pharmacokinetic software, including 
peak concentration (C max ), time to peak concentration (T max ), area under the concentration-
time curve (AUC), observed final concentration (C last ) , last detectable time (T last ), C max /T max , 
etc. 
Cellular kinetic analysis was performed based on PKS. Descriptive statistical analysis of 
blood CAR copy number versus time data was performed according to the planned sampling 
time. The arithmetic mean, standard deviation, median, maximum, minimum, coefficient of 
variation, and geometric mean of blood CAR copy number at each time point were calculated. 
Individual and mean blood CAR copy number versus time curves were plotted. 
Pharmacodynamic analysis 
Based on the pharmacodynamic analysis set, descriptive statistical analysis was performed 
on the pharmacodynamic indicators at each visit time point, and the mean, standard deviation, 
median, minimum value, maximum value, geometric mean, and geometric mean coefficient of 
variation were reported. 
If necessary, additional PD analyses can be performed. 
Exposure-response (efficacy or safety endpoint) analyses may be performed if supported 
by data. 
Immunogenicity analysis 
Immunogenicity samples will be collected for this study as described in the evaluation plan. 
Immunogenicity results will be summarized by number of patients and percentage using 
descriptive statistics. The incidence of positive ADA in patients with detectable ADA will be 

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reported. If data allow, the impact of immunogenicity on PK, efficacy, and safety will be 
assessed. 
Other translational research analyses 
This study will conduct translational research to analyze the correlation between changes 
in cytokines, biomarkers, and tumor microenvironment and clinical outcomes, as well as 
lentiviral insertion site analysis, replication-competent lentivirus (RCL) analysis, and CAR-T 
cell phenotypic changes . 
Analysis of the correlation between companion diagnostic reagents and drug efficacy 
using the Claudin 18.2 protein expression results detected by the cell tight junction protein 
(Claudin) 18.2 antibody reagent (immunohistochemistry method) to evaluate the effectiveness 
of IMC002 in treating patients with gastric or gastroesophageal junction adenocarcinoma with 
positive Claudin 18.2 expression. 
period : Expected to be from May 2025 to May 2027 
 
 

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Abbreviations 
Abbreviations 
Chinese definition/explanation 
ADA 
Antidrug antibodies 
AE 
Adverse events 
ALP 
Alkaline phosphatase 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
AUC 
Area under the concentration-time curve 
BIRC 
Blinded Independent Imaging Review Committee 
CABG 
Coronary artery bypass grafting 
CAR 
Chimeric antigen receptor 
CD3ζ 
Cluster of differentiation 3 ζ chain , TCR complex component, CD3 intracellular 
signaling region ζ chain, also known as zeta, abbreviated as Z 
CDx 
Companion diagnostics 
Claudin 
A family of proteins whose role is to maintain tight junctions that control the 
exchange of molecules between cells 
Claudin 18.2 
A subtype of the Claudin protein family, a highly selective molecule, referred to 
as CLDN18.2 
CLDN18.2 CAR-T cells 
Autologous T cells modified with chimeric antigen receptors targeting 
CLDN18.2 
C max 
Peak concentration 
CMV 
Cytomegalovirus 
Cr 
Creatinine 
CRF 
Case Report Form 
CT 
Computed tomography 
CTCAE 
Common terminology criteria for adverse events 
CTL 
Cytotoxic T lymphocytes 
DCR 
Disease control rate 
DLT 
Dose -limiting toxicity 
DOR 
Duration of remission 
EORTC 
European Organization for Research and Treatment of Cancer 
FDA 
U.S. Food and Drug Administration 
GCP 
Good Clinical Practice Guidelines for Drug Clinical Trials 
GMP 
Good Manufacturing Practice for Pharmaceuticals 
GVHD 
Graft-versus-host disease 
Hb 
Hemoglobin content 
HER2 
human epidermal growth factor receptor 2 
HTLV 
Human T-lymphotropic virus 
ICANS 
Immune cell therapy-related neurotoxicity syndrome 
IDMC 
Independent Data Monitoring Committee 

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IFN-γ 
Interferon-gamma 
IL 
interleukins 
ICT 
Investigator's choice of treatment 
LVEF 
Left ventricular ejection fraction 
LYM 
lymphocytes 
MRI 
Nuclear magnetic resonance imaging 
ORR 
Objective response rate 
OS 
Overall survival 
PCI 
Percutaneous coronary intervention 
PD 
Disease progression 
PDX 
Human tissue xenotransplantation 
PFS 
Progression-free survival 
PK 
Pharmacokinetics 
PBMC 
peripheral blood mononuclear cells 
P LT 
platelets 
RCL 
Replication-competent lentivirus 
RP2D 
Recommended Phase II dose 
SAE 
Serious adverse events 
scFv 
single-chain antibody fragments 
SD 
Stable disease 
SMC 
Safety Monitoring Committee 
TCR 
T cell receptor 
Tmax 
Peak time 
TNF-α 
Tumor necrosis factor-α 
TRAE 
Treatment-related adverse events 
TTR 
Time to relief 
ULN 
Upper limit of normal 
WBC 
leukocyte 
 
 

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1. Introduction 
1.1 Disease Background 
According to Global Cancer Statistics 2022 [1] , gastric cancer is the fifth most common 
malignant tumor in terms of morbidity and mortality worldwide, with approximately 970,000 cases 
per year, accounting for 4.9% of the total number of new cancer patients, and approximately 
660,000 deaths per year, accounting for 6.8% of the global cancer deaths. Due to differences in 
lifestyle, gastric cancer is more prevalent in Asia: 71.4% of cases and 70.1% of deaths are from 
Asia. In China, the number of new cases of gastric cancer accounts for 37% of the global total, and 
the number of deaths accounts for 39% of the global total. It is a common malignant tumor in 
China, with approximately 360,000 new cases of gastric cancer per year, ranking fifth in the 
incidence of malignant tumors in China, and approximately 260,000 deaths. The mortality rate is 
second only to lung cancer and liver cancer, ranking third in the mortality rate of malignant tumors, 
accounting for approximately 10.1% of all malignant tumor deaths, and the 5-year survival rate is 
26.4%. The burden of gastric cancer in China is severe and needs to be addressed urgently. 
According to the National Comprehensive Cancer Network (NCCN) and the Chinese Society 
of Clinical Oncology (CSCO) gastric cancer diagnosis and treatment guidelines, it is currently 
recognized that for patients with no chance of surgical cure or metastatic gastric cancer, 
comprehensive treatment with systemic anti-tumor drugs as the main treatment should be adopted 
[2] [3] . In China, the current drug treatment for gastric cancer includes chemotherapy drugs, 
molecular targeted drugs and immune checkpoint inhibitors. The overall prognosis of advanced 
gastric cancer is poor, the effect of chemotherapy alone has entered a bottleneck period, the 
selection of targeted drugs is limited, and the efficacy of immunotherapy alone in the overall 
population is poor. PD-1/PD-L1 monoclonal antibody combined with chemotherapy has become 
the first-line treatment recommendation. Fluorouracil, platinum and taxane are the main 
chemotherapy drugs for advanced gastric cancer. Usually, the first-line chemotherapy regimen is 
based on fluorouracil drugs, combined with platinum and/or taxane drugs to form a two-drug or 
three-drug chemotherapy regimen. In China, the two-drug combination regimen of fluorouracil 
and platinum drugs is more recommended [3] . 
First-line treatment of gastric cancer: Patients with advanced gastric cancer or 
esophagogastric junction adenocarcinoma are divided into three categories according to human 
epidermal growth factor receptor 2 (HER2) positive, HER2 negative, and dMMR/MSI-H, 
regardless of HER2 status, to determine the first-line treatment plan. For patients with HER2-
negative disease (IHC 0 or 1+, or 2+ but FISH-), if the PD-L1 CPS is ≥5, the first-line treatment 
recommendation is FOLFOX/XELOX combined with nivolumab, or XELOX combined with 
sintilimab (1A), or XELOX combined with sugemalimab. If the PD-L1 CPS is ≥10, XELOX or 
FP combined with pembrolizumab is also recommended. If the PD-L1 TAP is ≥5%, XELOX or 
FP combined with tislelizumab is recommended. If there is no PD-L1 CPS score, the recommended 
two-drug combination chemotherapy regimens are oxaliplatin/cisplatin + fluorouracil (5-FU or 

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capecitabine or tegafur) (1A), or paclitaxel/docetaxel combined with fluorouracil (5-FU or 
capecitabine or tegafur) (2A). In addition, canidolizumab combined with XELOX is also approved 
for the first-line treatment of HER2-negative advanced gastric cancer regardless of PD-L1 
expression status. For patients with dMMR/MSI-H, regardless of HER2 status, there is no Class I 
recommendation. Class II recommendations include nivolumab combined with ipilimumab or 
pembrolizumab alone (2B), or Class III recommendations include PD-1 monoclonal antibody 
combined with chemotherapy (2B). Second-line treatment for gastric cancer: For second-line 
treatment of HER2-negative advanced gastric cancer, Class I recommendations include paclitaxel 
combined with ramucirumab (1A) or single-agent chemotherapy (paclitaxel/docetaxel, irinotecan) 
(1A). For patients with dMMR/MS-H, regardless of HER2 status, if they have not previously 
received PD-1/PD-L1 monoclonal antibodies, envolizumab (2A), tislelizumab (2A), or serotonin 
(2A) are recommended. If they have previously received PD-1/PD-L1 monoclonal antibodies, the 
second-line treatment option is based on HER2 status (Class 3). The phase III RAINBOW global 
study showed that the ORR for second-line paclitaxel + ramucirumab and paclitaxel + placebo was 
28% vs. 16%, the median PFS was 4.4 months vs. 2.9 months, and the median OS was 9.6 months 
and 7.4 months, respectively . [4] The RAINBOW-ASIA study , which was mainly conducted in the Chinese 
population , showed similar results. The ORR for second-line paclitaxel + ramucirumab and 
paclitaxel + placebo was 27% vs. 22%, the median PFS was 4.1 months vs. 3.5 months, and the 
median OS was 8.7 months and 7.9 months, respectively . [5] The WJOG4007 [6] and KCSG ST1001 [7] 
studies conducted in Japan and South Korea showed that the ORR of irinotecan and paclitaxel as 
second-line chemotherapy for gastric cancer was approximately 14% to 21%, with a median PFS 
of 2.1 to 3.6 months and a median OS of 7.0 to 9.5 months. There is still a serious unmet clinical 
need for second-line treatment of advanced gastric cancer, and more effective treatment options 
for gastric cancer need to be actively explored clinically. 
Third-line treatment for gastric cancer: The third-line treatment for advanced gastric cancer 
is the targeted therapy drug apatinib alone (1A) (HER2 positive or negative). In a placebo-
controlled study, the ORR of apatinib alone for the third-line treatment of advanced gastric cancer 
was only 2.84%, with a median PFS of 2.6 months vs. 1.8 months and a median OS of 6.5 months 
vs. 4.7 months [8] . Or nivolumab alone is recommended for third-line use only when PD-1/PD-L1 
monoclonal antibodies have not been used before (1A). In a placebo-controlled study, the ORR of 
nivolumab for the third-line treatment of advanced gastric cancer was 11.2% , with a median PFS 
of 1.61 months vs. 1.45 months and a median OS of 5.26 months vs. 4.14 months. With the 
approval of multiple first-line immunotherapy indications for gastric cancer, it is rarely used in 
third-line treatment in clinical practice. Third-line chemotherapy for advanced gastric cancer only 
involves small sample studies, but the benefit of chemotherapy is unclear. Therefore, clinically, 
there is still a need to actively explore more effective treatment options for gastric cancer. 
Gastroesophageal junction adenocarcinoma and gastric cancer share similar underlying 
pathogenesis and genomic alterations and are often discussed as a single cancer type. 
CLDN18.2 (also known as Claudin 18.2, later unified as CLDN18.2) is a tight junction protein, 

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which is an isoform produced by alternative splicing of the CLDN18 gene. The human CLDN18 
gene has two different exons 1. After transcription, alternative splicing ultimately produces two 
protein isoforms CLDN18.1 and CLDN18.2 with different sequences only at the N-terminus. The 
two isoforms differ by only eight amino acids in the extracellular loop 1. The isoform CLDN18.1 
is only expressed in lung tissue in normal tissues, while CLDN18.2 is expressed in gastric tissue. 
Except for gastric tissue, it is almost not expressed in other normal tissues, and is specifically 
expressed in solid tumor cells such as the stomach, esophagus, pancreas, ovary and lung cancer [9] . 
The expression of CLDN18.2 in normal tissues is limited to differentiated gastric mucosal 
epithelial cells, but not in the gastric stem cell area. When cancer occurs, CLDN18.2 is expressed 
in primary gastric cancer and its metastatic lesions. According to reports, CLDN18.2 is positively 
expressed in approximately 80% of gastric cancer tissues and moderately to strongly expressed in 
approximately 50% of gastric cancer tissues [9] [10] . Therefore, CLDN18.2 is an ideal target for the 
treatment of CLDN18.2-positive digestive system tumors. 
Because the high specificity of CLDN18.2 helps T cells recognize tumors, it is used in 
chimeric antigen receptor T (CAR-T) cell therapy. Although CAR-T cell therapy has encountered 
setbacks in solid tumors, breakthroughs may be made because human tissue xenograft (PDX) 
models can verify in vivo efficacy compared with standard therapies, proving that CLDN18.2-
specific CAR-T cells can serve as a promising treatment strategy for other potential CLDN18.2-
positive tumors. 
Currently, the types of products targeting CLDN18.2 worldwide include monoclonal 
antibodies, bispecific antibodies, CAR-T, and ADC. The high specificity of CLDN18.2 helps T 
cells recognize tumors and is used for chimeric antigen receptor T (CAR-T) cell therapy. Compared 
with standard therapy, CLDN18.2-specific CAR-T cells can be used as a promising treatment 
strategy for CLDN18.2-positive tumors, especially gastric cancer [11] . 
Currently, several companies in China are researching CAR-T products targeting CLDN18.2. 
Legend Biotech's LCAR-C18S and Casci Biopharmaceuticals' CT041 are among the most 
advanced. Both are CAR-T products targeting CLDN18.2. Legend Biotech's LCAR-C18S is 
currently in Phase I studies. Casci Biopharmaceuticals' CT041 is currently conducting multiple 
studies and has submitted and received a marketing authorization application in China. 
The final analysis data of the reported CT041 IIT study showed that 98 patients with advanced 
digestive system tumors received CT041 infusion, of which 89 patients received 2.5×108 CAR -T 
cells/patient, 6 and 3 patients received 3.75×108 and 5×108 CAR -T cells/patient, respectively. No 
dose-limiting toxicity (DLT), treatment-related death or immune effector cell-associated 
neurotoxicity syndrome (ICANS) was reported in the study. Cytokine release syndrome (CRS) 
occurred in 96.9% of patients, all of which were grade 1-2. Gastric mucosal damage was reported 
in 8 patients (8.2%). CT041 was generally well tolerated and had controllable safety risks. In terms 
of efficacy, a total of 59 patients with gastric cancer / gastroesophageal junction adenocarcinoma 
who had failed at least one first-line treatment received CT041 monotherapy, of which 51 had 

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target lesions at baseline. The ORR and DCR were 54.9% ( 28/51 ) and 96.1% ( 49/51 ), 
respectively. The median PFS and median OS of all 59 patients with gastric cancer / 
gastroesophageal junction adenocarcinoma were 5.8 months ( 95% CI : 4.1 , 8.0 ) and 9.0 months 
( 95% CI : 7.0 , 11.9 ), respectively. In the population of gastric cancer/gastroesophageal junction 
adenocarcinoma patients who had previously failed first-line treatment, the median PFS and 
median OS were 9.3 months ( 95% CI : 3.7, 14.6) and 11.1 months ( 95% CI : 6.9, 17.8), 
respectively. There were 26 patients with gastric cancer / gastroesophageal junction 
adenocarcinoma who had failed second-line treatment , with median PFS and median OS of 7.1 
months ( 95% CI : 3.8 , 8.4 ) and 10.1 months ( 95% CI : 6.7 , 20.4 ), respectively . There were 11 
patients with gastric cancer / gastroesophageal junction adenocarcinoma who had failed third-line 
or higher treatment , with median PFS and median OS of 4.1 months ( 95% CI : 2.2 , 5.3 ) and 5.7 
months ( 95% CI : 2.6 , 8.0) , respectively. ), and in the third cohort of 5 patients with gastric cancer 
/ gastroesophageal junction adenocarcinoma, CT041 was used as a sequential treatment after first-
line treatment. The median PFS and median OS were 15.2 months ( 95% CI : 6.8 , not yet reached) 
and 16.4 months ( 95% CI : 7.0 , not yet reached), respectively. The results of this clinical study 
showed that CT041 has a good safety profile and has a good clinical efficacy when combined with 
the Baizi Qinglin regimen in the 2.5×108 dose group [12] . 
IMC002, an autologous cell therapy developed independently by Suzhou Imufeng 
Biotechnology Co., Ltd. (Imufeng), is an infusion of autologous T cells modified with a chimeric 
antigen receptor targeting CLDN18.2. It is produced from the patient's own genetically engineered 
T cells and is a single-patient, single-batch specialty drug. This product received Orphan Drug 
Designation (ODD) from the FDA for the treatment of advanced gastric cancer on July 18, 2022 , 
and Fast Track Designation (FTD) from the FDA on December 6, 2024, for the treatment of 
patients with unresectable, locally advanced, recurrent, or metastatic CLDN18.2-positive gastric 
cancer . The clinical trial application for this product (Acceptance Number: CXSL2300041, 
Protocol Number: IMC002-RT01) received implicit approval from the CDE on April 6, 2023. The 
first patient was enrolled in August 2023. Dose-escalation and dose-expansion studies have been 
completed, demonstrating excellent safety and efficacy data. 
Binding data from nonclinical studies of IMC002 demonstrated that the extracellular VHH 
domain of the IMC002 CAR specifically binds to the CLDN18.2 antigen and its positive cells with 
strong affinity. Furthermore, this VHH fragment does not bind to CLDN18.1-positive cells, 
demonstrating excellent specificity. Upon stimulation with CLDN18.2-positive cells, the IMC002 
CAR-T cells secrete high levels of IFN-γ, TNF-α, and IL-2, and exhibit dose-dependent 
cytotoxicity against CLDN18.2+ (NUGC4) cells . In vivo pharmacodynamic studies demonstrated 
that IMC002 significantly inhibited tumor growth in an immunodeficient mouse subcutaneous 
NUGC4-luc tumor-bearing model at doses ranging from 1 to 5×10 6 CAR-T cells/mouse. 
Furthermore, in a PDX model, which more closely reflects the patient's tumor landscape, IMC002 
CAR-T cells demonstrated significant inhibition of the growth of subcutaneous gastric cancer 
xenografts. Results from preliminary tissue distribution experiments demonstrated that CAR-T 

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cells possess excellent tumor targeting. Single-dose toxicity studies revealed that IMC002 CAR-T 
cells did not cause significant weight loss at a dose of 5×10 6 CAR-T cells/mouse. 
Histopathological examinations at the study endpoint revealed no significant tissue toxicity in the 
IMC002-treated group compared to control T cells, and a better safety profile than competing 
products. These findings suggest that IMC002 has the potential to treat CLDN18.2-positive 
advanced digestive system tumors. 
CLDN18.2 is a target for digestive system tumors. Drugs targeting the same target have shown 
good clinical trial results in the past. The CAR-T product CT041 targeting CLDN18.2 and the 
monoclonal antibody product Zolbetuximab have both shown good safety and preliminary efficacy 
in clinical trials [13] [14] . 
In summary, CLDN18.2 may become a promising target for the treatment of CLDN18.2-
positive advanced digestive system tumors. 
1.2 Preclinical Study Results of IMC002  
1.2.1 Overview of IMC002 Preclinical Studies 
Existing nonclinical data indicate that CLDN18.2 is rarely expressed in normal tissues other 
than gastric tissue; however, it is specifically expressed in solid tumor cells such as those in the 
stomach, esophagus, and pancreas, making CLDN18.2 an ideal target for these tumors. Binding 
data from nonclinical studies of IMC002 demonstrate that the extracellular VHH domain of the 
IMC002 CAR specifically binds to the CLDN18.2 antigen and its positive cells with strong affinity. 
Furthermore, this VHH fragment does not bind to CLDN18.1-positive cells, demonstrating high 
specificity. Upon stimulation with CLDN18.2-positive cells, IMC002 secretes high levels of IFN-
γ, TNF-α, and IL-2, and exhibits a dose-dependent cytotoxic effect against CLDN18.2+ cells 
(NUGC4). Further in vivo pharmacodynamic studies demonstrated that IMC002 significantly 
inhibited tumor growth in the NUGC4-luc subcutaneous tumor-bearing model in immunodeficient 
mice at doses of 1-5×10 6 CAR-T cells/mouse and 1.5-5×10 8 CAR - T cells/kg mouse body weight. 
Furthermore, in a PDX animal model, which better reflects the real-world tumor state in patients, 
IMC002 significantly inhibited the growth of subcutaneous gastric cancer xenografts. Preliminary 
tissue distribution studies and final experiments demonstrated that IMC002 CAR-T cells, 
developed using the IND process, achieved the highest tumor exposure. Results from a formal GLP 
single-dose toxicity study showed that IMC002 administered intravenously to NOG tumor-bearing 
mice at doses of 1.5×10 CAR - T cells/kg and 5.0 ×10 CAR - T cells/kg primarily revealed test article-
related gastric squamous epithelial hyperplasia, atypical glandular regeneration, and 
erosions/ulcers. Other findings were due to mononuclear cell infiltration caused by GVHD. The 
HNSTD (highest non-serious toxic dose) of IMC002 was 5.0×10 CAR - T cells/kg. Toxicity studies 
demonstrated a favorable safety profile and tolerability, indicating that IMC002 has the potential 
to treat CLDN18.2-positive solid tumors. A summary of existing nonclinical study data is provided 
below . 

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1.2.2 IMC002 Exists Preclinical Research Data 
Suzhou Immofeng Biotechnology Co., Ltd. conducted in vitro functional characterization and 
proof-of-concept studies for IMC002, as well as comprehensive preclinical GLP safety, efficacy, 
and pharmacokinetic evaluations. To evaluate the preclinical in vivo efficacy of IMC002, an 
immunodeficient tumor-bearing mouse model was designed and utilized. Key preclinical data are 
summarized below: 
(1) Pharmacological research 
a) In vitro pharmacodynamic studies: 
The binding properties of the IMC002 CAR were evaluated using the CLDN18.2-specific 
VHH antibody BC008 as a surrogate molecule. In vitro binding studies demonstrated that BC008 
exhibited high specific binding affinity for recombinant human CLDN18.2 (KD of 0.592 nM) and 
cell-surface expressed CLDN18.2 (EC50 range: 10.37 nM to 60.39 nM), while no binding was 
detected for the related splice variant CLDN18.1. Consistent with the findings at the protein level, 
IMC002 induced potent cytotoxicity against CLDN18.2-positive cells (293T-CLDN18.2 and 
NUGC4-luc) in a dose-dependent manner, accompanied by high levels of cytokine release (IL-2 , 
IFN-γ, and TNF-α ). On the other hand, IMC002 failed to induce cytotoxicity or cytokine 
production in cells expressing CLDN18.1 or CLDN18-negative cells, suggesting that IMC002 has 
minimal off-target toxicity in non-gastric tissues. 
IMC002 cross-reacts with mouse CLDN18.2 ( mCLDN18.2 ) as demonstrated by dose-
dependent killing of cells expressing mCLDN18.2 and high levels of IFN- γ production ; therefore, 
mice are considered a pharmacologically relevant species. 
b) In vivo pharmacodynamic studies: 
IMC002 was evaluated in two mouse xenograft models . The first model was a cell-derived 
xenograft model established by subcutaneously inoculating 1.5×10 8 human gastric cancer cells, 
NUGC4-luc , in the right axilla of immunodeficient mice . Furthermore, the antitumor effect of 
IMC002 was confirmed in an immunodeficient mouse model bearing a patient-derived gastric 
cancer xenograft (PDX). Antitumor activity was assessed by measuring the relative tumor volume 
between the test and control groups and expressing it as tumor volume inhibition ( TGI ). Vehicle-
treated mice served as a basal control for tumor growth. The in vivo antitumor effects of IMC002 
are summarized in Table 1 . 
Table 1 In vivo anti-tumor effects of IMC002 in various tumor xenograft models 
dose 
(× 10 8 CAR-T 
cells /kg) 
TGI (%) 
NUGC4-luc 
PDX 
Exp1 
Exp2 
Exp3 
Exp1 
Exp2 
0.25 (F) 
- 
23.43 
- 
- 
- 
0.75 (F) 
- 
0.54 
- 
- 
- 
1 (F) 
- 
- 
- 
- 
99.82 
1.25 (F) 
- 
- 
- 
44.56 
- 

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dose 
(× 10 8 CAR-T 
cells /kg) 
TGI (%) 
NUGC4-luc 
PDX 
Exp1 
Exp2 
Exp3 
Exp1 
Exp2 
1.5 ( M/F) 
- 
- 
68.8 (M) 
30.1 (F) 
- 
- 
2.5 (F) 
100 
73.14 
- 
- 
- 
3 (F) 
- 
- 
- 
- 
99.61 
5 (M/F) 
- 
- 
92.2 (M) 
48.3 (F) 
- 
- 
Note: All in vivo pharmacodynamic studies were conducted by intravenous injection with a single-dose schedule; 
M: male; F: female. 
IMC002 well . No animal deaths, severe weight loss, or clinical symptoms related to the test 
substance were observed in mice given IMC002 at doses up to 5 × 10 8 CAR-T cells /kg. Dose-
dependent effects were observed in individual studies of the NUGC4-luc xenograft model, but not 
in the PDX model. In female animals in Exp2 , the anti-tumor activity of IMC002 against NUGC4-
luc gradually increased with increasing doses from 0.75 × 10 8 to 2.5 × 10 8 CAR-T cells /kg , 
and in Exp3 with increasing doses from 1.5 × 10 8 to 5 × 10 8 CAR-T cells /kg . In the PDX 
model, IMC002 had a significant effect at 1 × 10 8 CAR - T cells /kg . The dose range of ∼3 × 10 
8 cells /kg demonstrated robust anti-tumor effects without dose dependence. A comprehensive 
consideration of all models tested indicated that doses of 2.5 × 10 8 CAR-T cells /kg and above 
were effective. 
c) Secondary pharmacodynamics: 
The IMC002 CAR portion consists of an extracellular VHH domain that targets CLDN18.2 . 
The parental anti-human CLDN18.2 antibody BC008 , derived from the IMC002 VHH domain , 
was evaluated for binding to over 6,000 human membrane proteins using the Membrane Proteome 
Array (MPA).  
20 µg /mL of BC008 among 6,000 membrane proteins (over 94% of the human membrane 
proteome) identified potential membrane protein targets as CLDN18.2 , FCGR2B , and FCGR3B 
( Uniprot Nos . P56856-2 , P31994 , and O75015 , respectively ). FCGR2B and FCGR3B encode 
Fcγ receptors IIb and IIIb , respectively, which are low- affinity inhibitory receptors for the Fc 
region of immunoglobulin ( IgG ) γ ( NCBI gene report 10/2022 ). Non - specific binding between 
BC008 and FCGR2B/FCGR3B is likely mediated through their Fc regions, which are absent in the 
IMC002 CAR . Therefore, these non-specific binding events are absent in cells, demonstrating the 
high target specificity and low off-target binding of IMC002 . 
(2) Animal pharmacokinetic studies 
Results from a study of the IND-developed IMC002's CAR-T persistence in the blood and in 
vivo distribution in immunodeficient tumor-bearing mice showed that after a single intravenous 
administration of 5×10 CAR-T cells/kg of IMC002 to male and female NOG mice bearing 
subcutaneous tumors (human gastric cancer cell lines, NUGC4-Luc), a certain amount of CAR 

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gene DNA copy number was detected in the whole blood and several tissues of the mice. CAR 
gene DNA copy number first peaked in total DNA in tumor and lung tissues of the tumor-bearing 
mice on Day 7 after administration, and in total DNA in gastric tissue on Day 14 after 
administration. After reaching peak concentrations, concentrations in all tissues gradually 
decreased before gradually increasing over time until the end of observation (Day 70 after 
administration). IMC002 exposure was highest in the tumor, with some exposure observed in 
highly vascularized tissues such as the lung and liver, as well as in target immune organs such as 
the stomach and spleen. These results demonstrate that IMC002 exhibits good tumor targeting in 
animals. 
( 3) Toxicology studies 
a) Pharmacodynamics and GLP toxicity studies of IMC002 after a single intravenous 
injection into NOG tumor-bearing mice 
The results of the study showed that IMC002 was administered intravenously to NOG tumor-
bearing mice (subcutaneously transplanted with the human gastric cancer cell line NUGC4-Luc) 
at a single dose of 1.5×10 8 CAR T cells/kg and 5.0× 10 8 CAR T cells/kg, respectively. The main 
visible manifestations were test article-related gastric squamous epithelial hyperplasia and atypical 
glandular regeneration and erosion/ulceration. Other manifestations were multi-organ/tissue 
mononuclear cell infiltration due to GVHD, increased number of splenic white myeloid cells, 
increased number of bone marrow (sternum and femur) granulopoietic hematopoietic cells, and 
anti-tumor effects (such as increased IFN-γ production). The HNSTD (highest non-severe toxicity 
dose) of IMC002 was 5.0×10 8 CAR T cells/kg. 
b) Viral insertion site analysis 
Viral insertion site analysis was performed on batches of samples from the IND process. 
Results from five sample batches have shown that no insertion sites of potential clinical 
significance were detected in IMC002 under the IND process. Yimufeng also rigorously monitored 
the safety of lentiviral vectors during the development of IMC002, including the following: 1) 
strict control of the CAR gene copy number in the final product; 2) rapid release testing of the RCL 
of the CAR-T product using qPCR, with subsequent retrospective analysis of the RCL using a co-
culture assay; 3) lentiviral insertion site analysis of the final CAR-T product in process 
confirmation batches; and 4) RCL testing and lentiviral insertion site analysis of peripheral blood 
samples from subjects at protocol-specified follow-up time points after product infusion. 
c) In vitro tumorigenicity studies 
The in vitro tumorigenicity test of the IND process IMC002 CAR-T was studied through the 
soft agar cell clone formation ability experiment. The results showed that under the experimental 
conditions, the test product IMC002 could not form clones in soft agar, indicating that it does not 
have tumorigenicity in vitro. 
d) In vitro hemolysis test results 

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Under the experimental conditions, IMC002 at a theoretical concentration of 5.0×10 7 
cells/mL had no hemolytic effect on human erythrocytes in vitro and did not cause erythrocyte 
aggregation. 
Through the above studies, we have fully evaluated the in vivo and in vitro efficacy, tissue 
distribution characteristics, and safety risks of this product to prove that this product is safe and 
effective, which can support the clinical trials of IMC002. 
1. 3 IMC002 early clinical study results 
Our company has initiated a Phase I/IIa clinical study titled "An Open-label, Multicenter, 
Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of IMC002 in Subjects 
with Advanced Digestive System Cancers Positive for CLDN18.2 Expression" (Study Number: 
IMC002-RT01). The study aims to evaluate the safety and preliminary anti-tumor efficacy of 
IMC002 in patients with advanced digestive system cancers positive for CLDN18.2 expression, 
including but not limited to advanced gastric cancer/GEJ adenocarcinoma and advanced pancreatic 
cancer. This study assesses the safety, tolerability, efficacy, cellular metabolism kinetics, and 
pharmacodynamics of IMC002 in the treatment of advanced digestive tract cancers, including 
gastric cancer / GEJ adenocarcinoma and pancreatic cancer. The dose-escalation phase utilized a 
classic "3+3" dose-escalation strategy, with three doses ( 1.0 × 10⁸ , 2.5 × 10⁸ , and 5.0 × 10⁸ CAR -
T cells/ subject, hereafter referred to as the low, medium, and high doses ) completed . The Safety 
Monitoring Committee (SMC) discussed and decided to simultaneously initiate a dose expansion 
at the medium dose. As of April 3, 2025, a total of 24 subjects had received IMC002 in this clinical 
study, including 16 with gastric cancer (11 with advanced gastric cancer in the medium-dose group 
and 5 with advanced gastric cancer in the high-dose group at the RP2D ) and 8 with pancreatic 
cancer (3, 4, and 1 with advanced pancreatic cancer in the low-dose, medium-dose, and high-dose 
groups, respectively). All 9 patients in the dose-escalation phase ( 3 patients in each dose group , 
low, medium, and high ) completed DLT observation and were DLT-evaluable cases. The median 
follow-up time for all 24 patients in the dose-escalation and dose-expansion phases was 4.4 months 
(95% CI, 3.3, 7.7). 
In the IMC002-RT01 study, IMC002 demonstrated a manageable overall safety profile, with 
a favorable safety profile across all three doses. No DLTs were reported during the dose-escalation 
phase across all three doses. Treatment-related adverse events ( TRAEs ) with an incidence of 30% 
or greater included pyrexia, cytokine release syndrome (CRS), decreased white blood cell count, 
decreased neutrophil count, decreased lymphocyte count, hypoalbuminemia, hypokalemia, 
increased gamma-glutamyl transferase, increased alanine aminotransferase, hypocalcemia, 
hypertriglyceridemia, increased aspartate aminotransferase, increased alkaline phosphatase, 
anemia, decreased platelet count, vomiting, increased fibrinogen degradation products, 
hypophosphatemia, nausea, decreased appetite, and abnormal electrocardiogram T waves. A total 
of 20 patients (83.3%, 20/24) experienced grade ≥3 TRAEs ; grade ≥3 TRAEs were mainly blood 
cell counts caused by lympholysis pretreatment, including decreased white blood cell count (58.3%, 
14/24), decreased lymphocyte count (58.3%, 14/24), decreased neutrophil count (37.5%, 9/24), 

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increased γ-glutamyl transferase (29.2%, 7/24), hypokalemia (16.7%, 4/24), anemia (12.5%, 
3/24), increased lipase (12.5%, 3/24), decreased platelet count (8.3%, 2/24), as well as upper 
gastrointestinal bleeding, peripheral edema, infectious pneumonia, increased blood creatine 
phosphokinase, increased interleukin level, hyperkalemia, coronary artery atherosclerosis, gastritis, 
respiratory failure and decreased fibrinogen in 1 patient (4.2%, 1/24). A total of 4 patients ( 18.8% , 
3/16 ) experienced investigator-assessed treatment-related serious adverse events ( SAEs ) during 
the study: upper gastrointestinal bleeding (4.2%, 1/24 patients), gastritis (4.2%, 1/24 patients), 
peripheral edema (4.2%, 1/24 patients), and hypokalemia (4.2%, 1/24 patients). All CRS were 
grade 1-2 , with no grade 3 CRS , and all resolved with treatment. Acute gastric mucosal injury / 
gastrointestinal bleeding occurred in 37.5 % of patients , mostly of CTCAE grade 1-2 severity, 
with an incidence of grade 3 events in 8.3 % . These events resolved with appropriate symptomatic 
treatment, and the risk of acute gastric mucosal injury / gastrointestinal bleeding was manageable. 
The cytopenias observed in this study were primarily related to pre-treatment with 
lymphadenopathy. The toxicity of IMC002 cell infusion on cytopenias was manageable, with no 
risk of prolonged cytopenias. IMC002-related cardiac events were reported in 4 patients (16.7%, 
4/24), including sinus tachycardia (4 cases, 16.7%, 4/24), heart failure (2 cases, 8.3%, 2/24), and 
palpitations (1 case, 4.2%, 1/24). No other CAR-T therapy-related events, including ICANS , 
cerebral edema, tumor lysis syndrome, HLH/MAS , DIC , infusion reactions, or allergic reactions, 
were observed in the study. 
In summary, IMC002 has an acceptable and manageable safety profile for patients with 
CLDN18.2 -positive locally advanced or metastatic gastric / GEJ adenocarcinoma. Reported 
adverse events were well characterized and generally reversible. 
Preliminary clinical data show that IMC002 has a highly effective anti-tumor effect on 
advanced gastric cancer. As of April 3, 2025, among 16 gastric cancer patients who failed at least 
two lines of systemic treatment (all patients had received PD-1/PD- L1 inhibitors, and 8 of them 
had failed at least three lines of systemic treatment), 8 achieved PR , with an overall ORR of 50 % 
( 95% CI : 24.7, 75.3 ). Among a total of 11 patients with advanced gastric cancer at a medium 
dose, 5 achieved PR, with an ORR of 45.5% ( 95% CI : 16.7, 76.6 ), which are numerically much 
higher than the currently available third-line treatments apatinib and nivolumab ( 2.84% and 
11.2% , respectively ). Following the approval of multiple first-line immunotherapy indications for 
gastric cancer, their use in third-line treatment is rare in clinical practice. All 16 gastric cancer 
patients enrolled in this study had received prior PD-1/PD-L1 inhibitors. The median duration of 
response (DOR) was immature ( 95% CI : NA , NA ). Of the eight patients who achieved a PR , 
only two had disease progression, while the remaining six showed ongoing tumor responses, with 
the potential for more durable responses with extended follow-up. The median progression-free 
survival (mPFS) of 6.9 months was achieved in all 16 patients and 11 patients receiving the RP2D 
mid-dose . This significantly prolongs the mPFS of currently available third-line treatments for 
advanced gastric cancer, including apatinib and nivolumab ( 2.6 and 1.61 months, respectively ), 
and even the median PFS of currently available second-line treatments for advanced gastric cancer 

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(2.1-4.4 months). IMC002 is used for the third-line or higher treatment of patients with CLDN18.2 
-positive locally advanced or metastatic gastric cancer. Compared with existing third-line 
treatments or even second-line treatments, IMC002 significantly improved the objective response 
rate, showed the potential for durable response, and prolonged PFS. 
1.4 Risks and Benefits 
According to 2022 Global Cancer Statistics , gastric cancer is the fifth most common 
malignant tumor in terms of morbidity and mortality worldwide, with approximately 970,000 cases 
and 660,000 deaths annually . In China, gastric cancer accounts for 37% of the global total in new 
cases and 39% of deaths . It is a common malignant tumor in China, with approximately 360,000 
new cases each year , ranking it fifth in the incidence of malignant tumors in China. There are also 
approximately 260,000 deaths , and the mortality rate ranks third among malignant tumors, after 
lung cancer and liver cancer, accounting for approximately 10.1% of all malignant tumor deaths . 
The five- year survival rate is 26.4% . The burden of gastric cancer in China is severe and urgently 
needs to be addressed. 
According to the National Comprehensive Cancer Network ( NCCN ) and Chinese Society 
of Clinical Oncology ( CSCO ) gastric cancer diagnosis and treatment guidelines, it is generally 
recognized that patients with incurable or metastatic gastric cancer should receive comprehensive 
treatment, primarily systemic anti-tumor drug therapy. In China, current drug treatments for gastric 
cancer include chemotherapy, molecularly targeted drugs, and immune checkpoint inhibitors. The 
overall prognosis of advanced gastric cancer is poor, and the efficacy of chemotherapy alone has 
reached a bottleneck. Targeted drug options are limited, and immunotherapy alone has poor 
efficacy in the general population . PD-1/PD-L1 monoclonal antibody combined with 
chemotherapy has become the preferred first-line treatment. For second-line treatment of HER2-
negative advanced gastric cancer, the Class I recommendation is paclitaxel combined with 
ramucirumab (1A) or single-agent chemotherapy (paclitaxel/docetaxel, irinotecan) (1A). The 
global phase III RAINBOW study showed ORRs of 28% and 16% for second-line paclitaxel plus 
ramucirumab and paclitaxel plus placebo, respectively. Median PFS was 4.4 months versus 2.9 
months, and median OS was 9.6 months and 7.4 months, respectively. The RAINBOW-ASIA study, 
conducted primarily in China, showed similar results: ORRs of 27% and 22% for second-line 
paclitaxel plus ramucirumab and paclitaxel plus placebo, respectively. Median PFS was 4.1 months 
versus 3.5 months, and median OS was 8.7 months and 7.9 months, respectively. The WJOG4007 
and KCSG ST1001 studies, conducted in Japan and South Korea, showed that single-agent 
irinotecan and paclitaxel chemotherapy as second-line treatment for gastric cancer achieved ORRs 
of approximately 14% to 21%, median PFS was 2.1 to 3.6 months, and median OS was 7.0 to 9.5 
months. There is still a serious unmet clinical need for second-line treatment of advanced gastric 
cancer, and clinically there is still a need to actively explore more effective treatment options for 
gastric cancer. 
CLDN18.2 is specifically expressed in gastric, esophageal, and pancreatic tumor cells and is 
not expressed in normal tissues except for gastric mucosal epithelial cells. Binding data from 

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nonclinical studies of IMC002 demonstrated that the extracellular VHH domain of the IMC002 
CAR specifically binds to the CLDN18.2 antigen and its positive cells with strong affinity. 
Conversely, this VHH fragment does not bind to CLDN18.1 - negative cells. Upon stimulation 
with CLDN18.2 -positive cells, the IMC002 CAR-T cells secreted high levels of IFN-γ , TNF-α , 
and IL-2 , and exhibited dose-dependent cytotoxicity against CLDN18.2+ cells ( NUGC4 ). 
Furthermore, IMC002 CAR-T cells demonstrated excellent tumor growth inhibition and safety in 
in vivo models. Therefore, CLDN18.2 is an ideal target for the treatment of advanced solid tumors 
positive for CLDN18.2 . 
Publicly published data on the same target also suggest that CLDN18.2 is a promising target 
for the treatment of CLDN18.2 -positive advanced digestive system tumors, including gastric and 
pancreatic cancer . Currently, global product lines targeting CLDN18.2 include monoclonal 
antibodies, bispecific antibodies, CAR-T cells, and ADCs . Among these, zolbetuximab has the 
largest number of monoclonal antibodies in development and is the most advanced. It has been 
approved for first-line combination therapy with chemotherapy for the treatment of advanced 
gastric cancer. Several ADCs have also entered pivotal registration studies, with monotherapy 
being used as second- or third-line treatments for advanced gastric cancer. The high specificity of 
CLDN18.2 facilitates T cell tumor recognition and is used in chimeric antigen receptor T ( CAR-
T ) cell therapy. Compared with standard therapies, CLDN18.2 -specific CAR-T cells offer a 
promising treatment strategy for CLDN18.2 -positive tumors, particularly gastric cancer. Currently, 
CT041 , developed by Cogen Biosciences, is making rapid progress in China. CT041 is currently 
undergoing multiple Phase I studies and has completed a pivotal Phase II clinical trial in China. Its 
application for marketing approval has been accepted and submitted in China. Published studies 
have demonstrated a tolerable safety profile and promising anti-tumor activity in patients with 
advanced gastric cancer / esophagogastric junction adenocarcinoma, demonstrating significant 
patient benefit. 
The IMC002-RT01 study evaluated the safety, tolerability, efficacy, cellular metabolism 
dynamics, and pharmacodynamics of IMC002 in the treatment of advanced gastrointestinal 
cancers, including gastric cancer / GEJ adenocarcinoma and pancreatic cancer. Preliminary clinical 
data demonstrated that IMC002 was safe, tolerable, and highly effective in treating advanced 
gastric cancer. Furthermore, as a CAR-T product, IMC002 requires only a single dose, offering 
greater convenience compared to traditional intravenous drug therapies, reducing hospital visits 
for follow-up medication. IMC002 demonstrated an acceptable and manageable safety profile in 
patients with CLDN18.2 -positive locally advanced or metastatic gastric cancer / GEJ 
adenocarcinoma. Reported adverse events were well characterized and generally reversible. 
In summary, based on the safety and efficacy results observed in the Phase I/IIa clinical study, 
the proposed recommended Phase II dose ( RP2D ) is safe and well-tolerated. Preliminary efficacy 
data demonstrate significant anti-tumor activity compared to existing treatments . IMC002 
demonstrates clear benefits that outweigh its risks, supporting further confirmatory clinical trials 
in China to confirm the benefit advantage. The proposed confirmatory clinical study is for patients 

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with inoperable locally advanced or metastatic gastric cancer and gastroesophageal junction 
adenocarcinoma who are CLDN18.2 -positive and have failed at least two lines of systemic therapy 
(disease progression or intolerance). This clinical study will also fully investigate the risks of 
CLDN18.2 CAR-T therapy and develop strategies for managing treatment-related adverse events. 
A product manual for hospital-based apheresis and reconstitution has also been developed to guide 
standardized procedures. Overall, IMC002 ( CLDN18.2 CAR-T ) has an acceptable benefit-risk 
ratio for the treatment of inoperable locally advanced or metastatic gastric cancer and 
gastroesophageal junction adenocarcinoma that are CLDN18.2 -positive and have failed at least 
two lines of systemic therapy (disease progression or intolerance). 
1.5 Basis for dose selection 
this Phase III clinical study (2.5x108 CAR -T cells/subject, single infusion) was selected based 
on data from an ongoing Phase I/IIa clinical study titled "An open-label, multicenter, dose-
escalation clinical trial to evaluate the safety and preliminary efficacy of IMC002 in subjects with 
advanced digestive system tumors that are positive for CLDN18.2 expression" (Study No.: 
IMC002-RT01). 
Safety: IMC002 was well tolerated across all three dose groups, with no DLTs observed . 
Among the 24 subjects, no IMC002 -related adverse events resulted in death. The incidence of 
CRS was 100% , limited to Grades 1-2, with no Grade 3 CRS . All resolved within approximately 
one week after treatment , demonstrating a manageable safety profile. Four IMC002 -related SAEs 
occurred : gastritis, upper gastrointestinal bleeding, bilateral lower extremity edema, and 
hypokalemia. These adverse reactions resolved with symptomatic treatment. These adverse 
reactions are related to the on-target mechanism of action of IMC002 and are manageable. No 
significant differences in safety were observed between dose groups, demonstrating an overall 
good and manageable safety profile. 
Efficacy: Among 24 patients, 9 achieved a best response (PR) , with an overall ORR of 37.5% 
( 95% CI : 18.8, 59.4 ). Eight of 16 patients with gastric cancer achieved a PR , with an overall 
ORR of 50 % ( 95% CI : 24.7, 75.3 ). In the 2.5 × 10⁻¹ dose group, 5 of 11 patients with gastric 
cancer achieved a PR , with an ORR of 45.5% ( 95% CI : 16.7, 76.6 ). In the 5.0 × 10⁻¹ dose 
group, 3 of 5 patients with gastric cancer achieved a PR , with an ORR of 60.0% ( 95% CI : 14.7, 
94.7 ). Both the mid- and high-dose groups demonstrated superior efficacy compared to existing 
therapies. 
As of April 3, 2025, among 16 gastric cancer patients, one additional patient in the medium-
dose group achieved a PR. Excluding one patient without target lesions in the medium-dose group, 
9 of 15 evaluable patients achieved a PR , for an overall ORR of 60%. Among 10 evaluable gastric 
cancer patients in the medium-dose group , 6 achieved a PR , for an ORR of 60 % . This 
demonstrates robust ORR efficacy data. 
Cellular kinetics: Clinical pharmacology studies found that among all 16 subjects, the overall 
median Cmax was 1467.2 copies/μg gDNA ; the median Cmax for the three subjects in the low-

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dose group was 611.4 copies/μg gDNA ; the median Cmax for the 10 subjects in the medium-dose 
group was 1467.2 copies/μg gDNA ; and the median Cmax for the three subjects in the high-dose 
group was 1589.5 copies/μg gDNA . Among six subjects with pancreatic cancer, the Cmax in the low-
dose group was 611.4 copies/μg gDNA ; the median Cmax in the medium-dose group was 2467.4 
copies/μg gDNA , with the medium-dose group exhibiting a higher median Cmax than the low-dose 
group. Among 10 subjects with gastric cancer, the median Cmax was 1467.2 copies/μg gDNA in 
7 subjects receiving the medium dose , and 1589.5 copies / μg gDNA in 3 subjects receiving the 
high dose . There was no significant difference in median Cmax between the medium and high 
doses . Overall, the low-dose group had the lowest median Cmax, while there was no significant 
difference in median Cmax between the medium and high-dose groups . There were no statistically 
significant differences between cancer types and dose groups. 
Pharmacodynamics: The main pharmacodynamic indicator, cytokine median Cmax , showed 
an upward trend in the medium-dose group, but no significant difference was found in the summary. 
For example, the median Cmax of IL-6 in the low-dose group was 559.1 pg/mL , the median Cmax of 
the medium-dose group was 1247.6 pg/mL , and the median Cmax of the high-dose group was 420.4 
pg/mL ; the median Cmax of IFN-γ in the low-dose group was 1687.4 pg/mL , the median Cmax of 
the medium-dose group was 2416.5 pg/mL , and the median Cmax of the high-dose group was 1122.3 
pg/mL ; the median Cmax of IP-10 in the low-dose group was 2981.2 pg/mL , the median Cmax of 
the medium-dose group was 5101.2 pg/mL , and the median Cmax of the high-dose group was 
5191.9 pg/mL ; the median Cmax of MCP -1 in the low-dose group was 1050.6 pg/mL , the median 
Cmax of the medium-dose group was 1219.3 pg/mL , and the median Cmax of the high-dose group 
was The median C max of IL -8 in the low-dose group was 54.1 pg/mL , the median C max of the medium-
dose group was 119.6 pg/mL , and the median C max of the high-dose group was 47.3 pg/mL . 
Based on the safety, efficacy, and clinical pharmacology data observed in the Phase I/IIa 
clinical trial of IMC002-RT01, the mid-dose group demonstrated favorable safety and efficacy, 
with no significant differences in safety or efficacy observed between the mid- and high-dose 
groups. No significant differences in PK parameters were observed between the mid- and high-
dose groups, but post-administration cytokine levels were significantly elevated in the mid-dose 
group compared with the high-dose group. Considering that CAR-T cells are living cellular 
therapeutics and will proliferate after infusion, there is no inherent correlation between dose and 
in vivo PK/PD parameters. Furthermore, considering production cost control and production 
success rates, and considering that the SMC recommends the mid-dose as the recommended dose 
for subsequent studies, the recommended clinical dose for this Phase III study was determined to 
be 2.5 × 10 8 CAR-T cells per subject, administered as a single infusion, for further Phase III 
clinical trials to confirm the clinical efficacy and safety of subjects at this dose level. 
2. Study objectives , study endpoints and estimated targets 
2.1 Research Objectives 
Main Purpose: 

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To evaluate progression-free survival ( PFS ) of IMC002 compared with investigator's choice 
of therapy ( ICT ) as third-line or higher-line treatment for patients with inoperable locally 
advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who are CLDN18.2 
positive . 
Secondary objectives: 
1) To evaluate the efficacy of IMC002 compared with ICT as a third-line or higher treatment 
for inoperable locally advanced or metastatic gastric or gastroesophageal junction 
adenocarcinoma that is positive for CLDN18.2 . 
2) Evaluate the safety of IMC002 and ICT . 
3) The metabolic kinetics of subjects infused with IMC002 were evaluated. 
Exploratory purpose: 
1) Long-term follow-up including immunogenicity analysis, lentiviral insertion site, and 
replication-competent lentivirus (RCL) was performed. 
2) To evaluate the changes in cytokines before and after administration of IMC002 and their 
correlation with efficacy and safety. 
3) To evaluate the correlation between biomarker changes before and after IMC002 
administration and efficacy and safety. 
4) To evaluate the phenotypic changes of CAR-T cells before and after IMC002 
administration. 
5) To evaluate the correlation between changes in the tumor microenvironment of tumor 
tissue samples before and after IMC002 administration and its efficacy and safety. 
6) To evaluate the effectiveness of subsequent IMC002 treatment in subjects in the control 
group. 
7) To evaluate the effects of IMC002 and ICT on the quality of life of subjects. 
2.2 Study Endpoints 
Primary study endpoint: 
PFS assessed by a blinded independent imaging review committee ( BIRC) . 
Key secondary endpoints: 
Overall survival ( OS ). 
Secondary study endpoints: 
1) PFS based on investigator assessment, objective response rate (ORR), disease control 
rate ( DCR ) , duration of response ( DOR ), and time to response (TTR) based on BIRC 
and investigator evaluation . 

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2) According to NCI CTCAE 5.0 ( except CRS /ICANS , according to 2019 ASTCT CRS 
/ICANS grading criteria were used to evaluate the type, frequency, and severity of 
treatment -emergent adverse events (TEAEs) and treatment- related adverse events 
(TRAEs) , as well as changes in laboratory values, vital signs, and ECG. 
3) PK indicators include analysis of the number of CAR-T cells and CAR copy number in 
peripheral blood : such as C max , T max , AUC, C last , T last , C max /T max , and maximum 
survival time. 
Exploratory endpoints: 
1) ADA immunogenicity analysis, lentivirus insertion site analysis, and replication-
competent lentivirus (RCL) detection were performed. 
2) The changes in cytokines (such as IL-2, IL-6, TNF-α, INF-γ, etc.) before and after 
IMC002 administration were detected before and after treatment. 
3) Additional exploratory testing may be conducted in research centers with appropriate 
conditions to support the evaluation of changes in biomarkers (such as CLDN18.2, etc.) 
before and after administration of IMC002. 
4) Additional exploratory testing can be performed in research centers with appropriate 
conditions to support the evaluation of changes in CAR-T cell phenotype before and after 
IMC002 administration (at time points with CAR-T expansion, such as if there are 
surplus samples). 
5) In research centers with corresponding conditions, additional exploratory tests can be 
carried out to support the CAR-T expansion, immune cell composition (CD4+/CD8+ 
ratio, memory cell phenotype, etc.) and changes in patient tumor tissues. 
6) The effectiveness of subsequent IMC002 treatment for subjects in the control group, 
including ORR, etc. 
7) Health-related quality of life was assessed using the parameters of the European 
Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-OG25 
questionnaires. 
2.3 Estimation Target 
2.3.1 Main estimation objectives  
The target estimate is a precise description of the treatment effect and reflects the strategy for 
dealing with events that occur during the trial that may affect the interpretation of the trial results 
(such as premature discontinuation of treatment).  
The primary clinical question of interest in this study was the relative effect of IMC002 as 
third-line or higher therapy in prolonging time to death or radiographic disease progression (per 
RECIST 1.1) compared with the control arm, ICT, in subjects with inoperable locally advanced or 

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metastatic gastric or GEJ adenocarcinoma who were CLDN18.2 positive, regardless of 
discontinuation of study treatment but before receiving off-study treatment after study entry, based 
on BIRC review . 
The primary objective was to capture treatment effect data regardless of discontinuation of 
study treatment while avoiding the confounding effect of any new anticancer therapy that was not 
part of the originally assigned treatment. During the course of this study, other clinical trials of 
drugs targeting CLDN18.2 were ongoing, and new drugs targeting CLDN18.2 were anticipated to 
be approved. Given the open-label nature of this study, it is possible that subjects in the control 
group could have switched to these newly approved or investigational therapies before disease 
progression, with the potential for this practice to affect treatment efficacy. Therefore, the primary 
focus was on assessing treatment efficacy in the absence of non-study treatment. 
The characteristics of the main estimation targets are as follows: 
1. 
Population: Adult patients with inoperable locally advanced or metastatic gastric or 
gastroesophageal junction adenocarcinoma who have previously received first-line 
therapy and are positive for CLDN18.2. For further details on this population, see Section 
4. Study Population . 
2. 
Objective variable: BIRC-assessed progression-free survival (PFS) was defined as the 
time from the date of randomization to the date of first radiographic disease progression 
(based on BIRC assessment according to RECIST 1.1 ) or death from any cause. 
3. 
Treatment of Interest: The assigned IMC002 or ICT treatment in the control group 
(regardless of whether study treatment was discontinued). For more details on the study 
treatment and control treatment, see Section 5. Study Treatment . 
4. 
Treatment of associated events: 
 
Discontinuation of Study Treatment: PFS will take into account all tumor assessments 
and death, regardless of discontinuation of study treatment for any reason (treatment 
strategy). 
 
Patients who underwent a crossover (for patients in the control group) or started a new 
anticancer treatment (for all patients) were treated with a hypothetical strategy in which 
PFS would be censored at the date of the last adequate assessment or at the date of 
randomization before the crossover or start of a new anticancer treatment. 
 
Any unforeseen concomitant events, such as those arising from public health 
emergencies, will be addressed through therapeutic strategies. 
5. 
HR ) between the two treatment groups . This HR will be estimated using a Cox 
proportional hazards model stratified by the randomization stratification factor . PFS will 
be tested using the log-rank test stratified by the randomization stratification factor. 

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3. Study Design 
3.1 Overview of Research Design 
This study is a multicenter, randomized, active-controlled, open-label, confirmatory clinical 
study to evaluate the efficacy and safety of IMC002 compared with ICT as third-line or higher-line 
treatment for subjects with advanced gastric/esophagogastric junction adenocarcinoma who are 
positive for CLDN18.2 expression . 
A schematic diagram of the study design is shown in Figure 1 . 
Subjects meeting the inclusion criteria will be randomly assigned to the experimental or 
control group in a 2:1 ratio. Following randomization, subjects in the experimental group will 
undergo peripheral blood mononuclear cell (PBMC) collection (abbreviated as apheresis), bridging 
therapy (if necessary), lymphoproliferative conditioning (abbreviated as lysozyme), and a single 
infusion of IMC002. Subjects in the control group will undergo apheresis and then receive 
investigator-selected treatment (ICT) until intolerable toxicity, progressive disease (PD), initiation 
of new anti-cancer therapy, or death. In the control group, if PD or intolerable toxicity develops 
after ICT treatment, eligible subjects who have been fully evaluated may receive lysozyme and 
IMC002 treatment. 
Randomization stratification factors included: 
 
Eastern Cooperative Oncology Group performance status (ECOG PS): 0 or 1 
 
Liver metastasis: yes or no 
 
Previous lines of systemic therapy: 2 lines * or ≥3 lines 
*Patients who received only first-line treatment with a combination of taxanes ( or anthracyclines ) , 
platinum, and fluorouracil and whose disease progressed as assessed by the investigator were considered to have 
failed the second-line treatment. 
Both groups of subjects will undergo relevant examinations according to the established visits 
in the trial flow chart to evaluate their efficacy, safety and cellular pharmacokinetics. 
A BIRC will be established in this study to evaluate the tumor status and treatment response 
of the subjects according to the BIRC charter. 

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Figure 1 Schematic diagram of the study design 
Experimental group: 
Trial interventions and treatments : including apheresis, bridging therapy (if necessary), 
lymphoblastic leukorrhea clearance, and IMC002 infusion. 
After 
randomization, 
the 
subjects 
will 
begin 
apheresis. 
Before 
apheresis 
to 
lymphoproliferative pretreatment, the researchers will judge the subject's status and consider 
bridging therapy based on the subject's clinical benefits and risks. The purpose of bridging therapy 
is to stabilize the subject's current disease status or reduce the subject's current tumor burden. The 
preferred drugs are those with gastric cancer indications in the instructions, or after the researchers 
combine clinical practice and the patient's previous medication status, irinotecan monotherapy can 
be used for 1 to 2 courses (recommended dose: irinotecan 150 mg/m 2 , intravenous drip, single 
dose) or FOLFIRI regimen (recommended dose: irinotecan 130-150 mg/m 2 , 5-fluorouracil 2400 
mg/m 2 , intravenous infusion, single dose) or paclitaxel (recommended dose: paclitaxel 135 mg/m 
2 , intravenous infusion, single dose) as bridging therapy. The use of bridging therapies other than 
the recommended regimen requires medical consultation and confirmation with the sponsor. 
Bridging therapy must be completed 7 days prior to lymphoproliferative conditioning, or a washout 
period of at least five half-lives of the bridging drug must be allowed (whichever is longer). Once 
the IMC002 product has been prepared and meets the inspection and release quality standards, if 
the subject meets the cell reinfusion criteria, IMC002 cell infusion can be performed. Subjects will 
receive a single infusion of two bags of IMC002 at a dose of 2.5×10 8 CAR-T cells per subject. 
Control group: 
After randomization, subjects will undergo single-dose sampling before receiving the 
investigator-selected treatment. Comparator drugs include apatinib mesylate, paclitaxel alone, 
docetaxel alone, or irinotecan alone. Drugs with gastric cancer indications in their package inserts 
are preferred, or selected by the investigator based on clinical experience and the patient's previous 
medication history. Dose adjustments are permitted based on the subject's tolerance. 
Apatinib mesylate: 850 mg, orally, once a day. 
Paclitaxel alone: 80 mg/m 2 of paclitaxel , intravenous drip, on day 1 , day 8 , day 15 , and repeated 

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every 28 days. 
Docetaxel alone: docetaxel 75 to 100 mg/m 2 by intravenous drip on day 1 , repeated every 
21 days. 
Irinotecan alone: 150-180 mg/m 2 by intravenous drip on day 1 , repeated every 14 days . 
Until intolerable toxicity, disease progression, initiation of new anti-cancer therapy, or death, 
whichever occurs first. The trial center is responsible for drug storage and distribution, and the 
investigator will conduct safety and efficacy assessments on the subjects according to the 
established visits. 
For subjects in the control group who have undergone apheresis and successfully prepared 
IMC002, if they develop PD or toxic intolerance after receiving ICT drug treatment , the researcher, 
after fully evaluating the subject's overall condition, believes that subsequent treatment with 
IMC002 is in the best interest of the subject and may recommend that the subject consider 
subsequent treatment with IMC002. Patients also have the right to choose subsequent salvage 
treatment that is in their best interests. If the subject is willing to receive this product, a further 
assessment of their condition before lymphoblastic leukemia and IMC002 cell infusion will be 
required, using the same assessment criteria as the experimental group. Those who meet the 
assessment criteria can begin the lymphoblastic leukemia and IMC002 treatment process, using 
the same treatment plan as the experimental group. 
Before a patient with PD, as assessed by the researcher, plans to receive IMC002 treatment, 
the BIRC-assessed PD auxiliary confirmation process must be initiated. For subjects whose PD is 
not confirmed by BIRC, their efficacy status judgment and treatment decision must be 
comprehensively evaluated and handled by the researcher. 
Subjects in both groups will undergo molecular pre-screening and related examinations 
according to the established visits in the trial flow chart to evaluate their efficacy, safety and cell 
dynamics (CAR copy number detection and cell metabolic dynamics-related assessments will only 
be performed on subjects receiving IMC002 infusion). 
A BIRC will be established in this study to evaluate the tumor status and treatment response 
of the subjects according to the BIRC charter. 
3.2 Random Methods 
After the subject signs the molecular pre-informed consent form, researchers from each trial 
center will pre-assign a screening number to each screened subject in order of priority. After 
passing the screening, the subject will fill out the screening information and obtain a random 
number. Each subject will have a unique random number. 
This study used a stratified block randomization method. Participants who met the inclusion 
criteria were randomly assigned to the experimental group and the control group in a 2:1 ratio. 
Randomization stratification factors included: (1) Eastern Cooperative Oncology Group 
performance status ( ECOG PS ): 0 or 1 ; (2) liver metastasis: yes or no; (3) number of previous 

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systemic treatment lines: 2 lines * or ≥3 lines. 
* Patients whose first-line treatment used three drugs simultaneously, including taxanes (or anthracyclines), 
platinums, and fluorouracils, and whose disease progressed as assessed by the investigator were considered to 
have failed the second-line treatment. 
3.3 Research Methods 
3.3.1 Molecular Pre-screening Phase 
CLDN18.2 IHC detection: 
all subjects signed the molecular pre-screening informed consent form, they used the 
companion diagnostic reagent Claudin 18.2 antibody reagent (immunohistochemistry) to perform 
CLDN 18.2 target screening and related molecular biological characteristics. If the central 
laboratory test results did not meet the CLDN 18.2 expression level required by the protocol , the 
pre-screening was considered a failure and subsequent screening was discontinued. 
CDx Development: 
Claudin18.2 expression in tumor tissue will be assessed using a companion diagnostic reagent, 
the Claudin 18.2 Antibody Reagent (Immunohistochemistry). The results will be used in clinical 
trial screening to evaluate the efficacy of IMC002 in the treatment of patients with gastric or GEJ 
adenocarcinoma 
positive 
for 
Claudin18.2. 
This 
companion 
diagnostic 
kit 
utilizes 
immunohistochemistry, performed on a Leica BOND-III stainer and accompanied by 
complementary reagents (such as the Bond Polymer Refine Detection immunochromatographic 
reagent). The kit will detect Claudin18.2 protein expression in 10% neutral formalin-fixed, 
paraffin-embedded (FFPE) tissue sections from gastric or GEJ adenocarcinoma. This testing will 
be performed at a central laboratory, and all subjects must submit FFPE tissue for Claudin18.2 
expression testing prior to enrollment. 
3.3.2 Screening period 
subjects with inoperable locally advanced or metastatic gastric or gastroesophageal junction 
adenocarcinoma whose central laboratory test results meet the protocol-required CLDN 18.2 
expression levels may enter the screening period after signing the master informed consent form. 
Subjects meeting the eligibility criteria will be randomly assigned to the experimental or control 
group in a 2:1 ratio. The screening period is defined as the period from signing the master informed 
consent form until subject randomization . 
3.3.3 Treatment period 
3.3.3.1 Experimental Group 
After randomization, subjects in the experimental group will begin apheresis, bridging 
therapy (if necessary), lymphoblastic leukemia removal, and IMC002 infusion. 
Single collection: 

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After randomization, subjects will begin apheresis for IMC002 preparation. 
Bridging therapy: 
Before the pretreatment of lymphoproliferative apheresis to lymphoproliferative depletion, 
the researcher shall judge the subject's condition and consider giving bridging therapy based on 
the subject's clinical benefits and risks. The purpose of bridging therapy is to stabilize the subject's 
current disease status or reduce the subject's current tumor burden. The preferred drugs are those 
with gastric cancer indications in the instructions, or after the researcher combines clinical practice 
and the patient's previous medication status, 1 to 2 courses of irinotecan alone (recommended dose: 
irinotecan 150 mg/m 2 , intravenous drip, single dose) or FOLFIRI regimen (recommended dose: 
irinotecan 130-150 mg/m 2 mg/m 2 , 5-fluorouracil 2400 Recommended dose: paclitaxel 135 mg/m
² , intravenous infusion, single dose) or paclitaxel (recommended dose: paclitaxel 135 mg/m² , 
intravenous infusion, single dose) as bridging therapy. The use of bridging therapy other than the 
recommended regimen requires medical consultation and confirmation with the sponsor. Bridging 
therapy must be completed within 7 days of lymphoproliferative conditioning, or a washout period 
of at least five half-lives of the bridging drug must elapse from the time of lymphoproliferative 
conditioning (whichever is longer). 
If the subject receives bridging therapy or the investigator believes the subject's disease 
condition requires reassessment, appropriate examinations may be performed, including but not 
limited to: imaging assessment, tumor biomarkers, blood routine, biochemistry and coagulation 
function, etc. If the subject experiences rapid hyperprogression, the investigator will need to assess 
the risks and benefits of the subject's subsequent trial process and determine whether the subject 
should undergo subsequent lymphoproliferative conditioning and infusion. If the subject achieves 
complete remission, no subsequent lymphoproliferative conditioning and infusion will be required. 
Pretreatment of rinsing: 
When the IMC002 product is prepared, if the subject meets the lymph node clearance 
pretreatment criteria, lymph node clearance pretreatment will be performed. 
• 
Drainage pretreatment assessment 
If the subject meets any of the following criteria before lymphoproliferative pretreatment and 
is judged by the researcher to be unsuitable for subsequent trial procedures, lymphoproliferative 
pretreatment cannot be continued or needs to be delayed, and infusion cannot be performed or 
needs to be delayed. 
1. 
ECOG performance status score ≥2 points; 
2. 
Active infection: If the subject requires systemic anti-infective treatment or has a body 
temperature of ≥38°C within 7 days before lymph node clearance pretreatment, the 
investigator must discuss this with the sponsor before starting lymph node clearance 
pretreatment; 

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3. 
Patients are assessed by the investigator to have a high risk of bleeding or perforation; 
4. 
with known or suspected central nervous system metastasis; 
5. 
Surgery, interventional therapy, radiotherapy or immunotherapy for the disease 
underwent within 2 weeks before lympholysis pretreatment; 
6. 
Blood tests: neutrophil count <1.5 ×10 9 /L; platelet count (PLT) <75×10 9 /L; 
hemoglobin content (Hb) < 8.0g /dL; 
7. 
Liver function: Alanine aminotransferase (ALT) >2.5×ULN, aspartate aminotransferase 
(AST) >2.5× ULN, serum total bilirubin (TB) >2 ×ULN; for patients with liver 
metastasis, AST and ALT >5×ULN; 
8. 
Renal function: creatinine clearance < 50 mL /min (according to the Cockcroft-Gault 
formula); 
9. 
Amylase and lipase > 1.5 × ULN; alkaline phosphatase (ALP) > 2.5 × ULN; for 
patients with bone metastases, ALP > 5 × ULN; 
10. International normalized ratio (INR) and partial prothrombin time (APTT) >1.5 × 
ULN; 
11. Oxygen supplementation is required to maintain blood oxygen saturation > 95% 
(referring to pulse oxygen); 
12. Systemic glucocorticoids were used within 7 days before the lymph node clearing 
pretreatment, and the cumulative dose exceeded 70 mg prednisone equivalent dose of 
glucocorticoids (except for those using inhaled or topical glucocorticoids); 
13. Any toxicity caused by bridging therapy has not recovered to CTCAE grade 2 or below; 
14. failure to complete the bridging therapy washout period; 
15. Other complications or toxicities may place the subject at inappropriate risk for 
lymphoproliferative conditioning and IMC002 cell infusion, including but not limited to 
the development of new arrhythmias in the subject that cannot be controlled by 
medication; hypotension requiring pressors; the researcher assesses the patient's presence 
of major organ dysfunction (such as severe heart disease, uncontrolled hypertension or 
diabetes, severe liver or kidney damage, pulmonary edema, severe lung infection, brain 
metastasis, etc.). If necessary, it is recommended to discuss the matter with the sponsor's 
medical department. 
• 
Pretreatment plan for clearing leucoderma: 
lympholysis conditioning regimen consists of fludarabine, cyclophosphamide, and nab-
paclitaxel (FNC) . If a subject is allergic to or intolerant of nab-paclitaxel, the investigator may 
administer fludarabine combined with cyclophosphamide (FC) based on the subject's condition. 

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( 1) FNC regimen: Fludarabine (F) combined with cyclophosphamide (C) + albumin-
paclitaxel (N) regimen 
Fludarabine 25 mg/m 2 /day × 2 days (day 1 and day 2 for clearing urethritis) 
Cyclophosphamide 250 mg/m 2 /day × 3 days (lymph clearance on the first, second, and third 
days) 
Albumin-paclitaxel 100 mg (on the second day of lymph node clearance) 
If the subject is allergic to or intolerant to albumin-paclitaxel, the researcher may choose the 
following FC lympholysis pretreatment regimen based on the subject's condition. 
(2) FC regimen: Fludarabine combined with cyclophosphamide regimen 
Fludarabine 20-25 mg/m 2 /day × 2 days 
Cyclophosphamide 500 mg/m 2 /day × 2 days 
The body surface area of the subjects was calculated according to the Stevenson formula 
Body surface area (m 2 ) = 0.0061 × height (cm) + 0.0128 × weight (kg) - 0.1529 
If the researcher needs to use a lymphoproliferative conditioning regimen for a subject beyond 
the protocol, this should be discussed with the sponsor. CAR-T cell infusion can begin 1-2 days 
after the subject has received the lymphoproliferative conditioning regimen. 
IMC002 cell infusion: 
After successful preparation of IMC002 injection and lymph node clearance pretreatment, 
subjects who are assessed by the researchers as qualified will continue to receive subsequent 
IMC002 infusion treatment . 
Pre-infusion assessment: 
Before IMC002 infusion, the subject's clinical status should not be significantly worse than 
that at the time of enrollment screening, as assessed by the investigator, which would increase the 
risk of IMC002 infusion. On the scheduled IMC002 infusion day, if the subject meets any of the 
following criteria, IMC002 infusion should be delayed: 
1. 
ECOG performance status score ≥2 points ; 
2. 
Active infection: If the subject requires systemic anti-infection treatment or has a body 
temperature ≥38°C, the infusion cannot be given or needs to be delayed; 
3. 
CTCAE grade 3 or higher non-hematologic toxicity (excluding grade 3 nausea, vomiting, 
diarrhea, or constipation) occurring after lympholysis pretreatment; 
4. 
Oxygen supplementation is required to maintain blood oxygen saturation > 95% 
(referring to pulse oxygen); 
5. 
Other complications or toxicities may place the subject at inappropriate risk for IMC002 

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cell infusion, including but not limited to the subject experiencing new arrhythmias that 
cannot be controlled by medication; hypotension requiring pressors; the researcher 
assesses the patient to have major organ dysfunction ( such as severe heart disease, 
uncontrolled hypertension or diabetes, severe liver or kidney damage, pulmonary edema, 
severe lung infection, brain metastasis, etc. ). If necessary, it is recommended to discuss 
the medical situation with the sponsor. 
For subjects who have completed cell preparation but do not meet the reinfusion criteria and 
need to delay infusion, if their body temperature does not return to normal within 7 days after the 
lymphatic ablation pretreatment or other toxicity does not recover to ≤ Grade 1, the investigator 
will evaluate whether the subject should receive another lymphatic ablation pretreatment. If for 
any reason the cell infusion is delayed for more than 7 days after the lymphatic ablation 
pretreatment, the infusion cannot be performed , or the investigator will evaluate whether the 
subject should receive another lymphatic ablation pretreatment to delay the infusion. It is 
recommended that the interval between two lymphatic ablations be no less than 4 weeks . 
IMC002 feedback: 
After successful preparation of IMC002 injection and lymph node clearance pretreatment, 
subjects who are assessed by the researchers as qualified will continue to receive subsequent 
IMC002 infusion treatment. 
Before cell infusion, sufficient backup medications (e.g., at least two doses of tocilizumab) 
should be available, and emergency facilities and equipment should be readily available to ensure 
prompt treatment in the event of a severe allergic reaction, severe hypotension, or other emergency. 
Thirty to sixty minutes before cell infusion , investigators may consider pre-treating subjects to 
prevent infusion reactions based on clinical experience , such as with histamines such as 
acetaminophen (300-1000 mg orally), promethazine hydrochloride (25 mg intramuscularly), or 
diphenhydramine (50 mg). Following infusion, each subject is recommended to remain 
hospitalized for 14 days, or the investigator may decide on the discharge date based on the subject's 
condition . 
3.3.3.2 Control Group 
Single collection: 
After randomization, subjects will be administered a single dose of IMC002 before receiving 
the investigator's selected treatment. 
Control treatment: 
Comparator drugs include apatinib mesylate, paclitaxel alone, docetaxel alone, or irinotecan 
alone. Drugs with a gastric cancer indication in the package insert are preferred, or selected by the 
investigator based on clinical experience and the patient's previous medication history. Dose 
adjustments are permitted based on the subject's tolerance. The trial will continue until toxic 
intolerance, disease progression, initiation of new anticancer therapy, or death, whichever occurs 

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first. The trial center is responsible for drug storage and distribution, and the investigator will 
conduct safety and efficacy assessments on the subjects according to scheduled visits. 
Apatinib mesylate treatment: 
850 mg, orally, once a day. 
Paclitaxel alone (only for subjects with contraindications to ramucirumab): 
Paclitaxel 80 mg/m 2 , intravenous drip, on day 1, day 8, day 15, and repeat every 28 
days. 
Docetaxel alone (only for subjects with contraindications to ramucirumab): 
Docetaxel 75-100 mg/m 2 , intravenous drip, on day 1, repeated every 21 days. 
Irinotecan alone: 
150-180 mg/m 2 , intravenous drip, on day 1, repeated every 14 days. 
For subjects in the control group who have undergone apheresis and successfully prepared 
IMC002 and develop PD or intolerable toxicity after a thorough evaluation, the BIRC assessment 
process for PD confirmation must be initiated before the investigator-assessed PD is confirmed 
and IMC002 treatment is planned. For subjects whose PD is not confirmed by the BIRC, the 
efficacy status assessment and treatment decision must be comprehensively evaluated by the 
investigator and medically confirmed with the sponsor. If the investigator fully evaluates the 
subject's overall condition and determines that subsequent IMC002 treatment is in the best interest 
of the subject, the investigator may recommend that the subject consider IMC002 treatment. 
Patients also have the right to choose subsequent salvage treatment that is in their best interests. If 
the subject is willing to receive this product, a further assessment of the subject's status before 
lymphoblastic ablation and IMC002 cell infusion will be required, using the same criteria as for 
the experimental group. Those who pass the assessment can begin the lymphoblastic ablation and 
IMC002 treatment process, using the same treatment plan as the experimental group. 
3.3.4 Follow-up period 
Tumor assessments will be conducted by the BIRC and investigators according to RECIST 
1.1 criteria. Starting from post-randomization apheresis, the first tumor assessment will be 
conducted at Week 8 ± 7 days (for patients in the IMC002 trial group, this must also be at least 
4 weeks after infusion). Tumor assessments will be conducted every 6 weeks ± 7 days thereafter 
until disease progression, as determined by the investigator and confirmed by the BIRC, initiation 
of new anti-cancer therapy, death, loss to follow-up, or study withdrawal, whichever occurs first. 
For patients in the control group who receive IMC002 infusion after progression, the first post-
infusion tumor assessment will be conducted at Week 4 ± 2 days after infusion. Thereafter, tumor 
assessments will be conducted every 6 weeks ± 7 days until disease progression, as determined 
by the investigator, initiation of new anti-cancer therapy, death, loss to follow-up, or study 
withdrawal, whichever occurs first. Survival status will be collected every 12 weeks after entering 

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survival follow-up. 
Tissue, blood, and serum samples will be collected from the subjects to evaluate characteristic 
information such as the expression ratio and intensity of the CLDN18.2 target, changes in 
biomarkers related to the tumor immune microenvironment characteristics and the overall immune 
characteristics of the body, and cytokine level analysis, cell dynamics, and immunogenicity 
analysis of IMC002 will be performed. 
3. 4 Study Suspension, Termination, and Withdrawal 
3.4.1 Study Suspension and Termination 
The sponsor has the right to suspend or terminate the clinical study early at any time. The 
reasons for suspending or terminating the study early may include, but are not limited to, the 
following: 
Unexpected, significant, or unacceptable risks occur to the enrolled subjects; 
The sponsor decides to suspend or stop the development of the drug. 
3.4.2 Termination of study treatment 
Discontinuation of study treatment means the permanent cessation of study treatment by a 
subject for any reason (before the completion of planned study drug administration, if any) and 
may be initiated by the subject or the investigator.  
If the investigator believes that continuing the study treatment may have an adverse effect on 
the subject's health, the investigator must terminate the study treatment for the subject. 
The current group study treatment should be terminated in the following cases:  
• Subject decision  
• The researcher decided  
• pregnancy  
• Other anti-tumor treatments prohibited in the " Prohibited Treatments " section were used 
during the study , including but not limited to radiotherapy, chemotherapy, immunotherapy, 
surgical treatment, etc.  
• Any situation where continued participation in the study may result in safety risks  
• If a subject in the experimental group shows rapid hyperprogression before receiving 
treatment, the researcher needs to evaluate the risks and benefits of the subject's subsequent trial 
process and determine whether the subject should undergo subsequent lymphoproliferative 
pretreatment and infusion. If the control group shows disease progression according to RECIST 
1.1 ( confirmed by BIRC assessment)  
• Adverse events requiring permanent discontinuation of study treatment  

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• Protocol deviations that pose a significant risk to the safety of the subjects  
• Withdrawal of informed consent and withdrawal from the study  
• Sponsor terminates study  
• die  
• Lost to follow-up  
If study treatment is terminated, the investigator should make every effort to understand the 
subject's main reason for termination of study treatment and record this information.  
Subjects who discontinued study treatment agreed to return for end-of-treatment and follow-
up visits as indicated in the assessment schedule. 
If a subject is unable or unwilling to attend any further visits, site staff should maintain regular 
telephone contact with the subject or a person designated by the subject in advance. Telephone 
contact is preferred according to the study visit schedule.  
at least a brief visit should be performed by office visit or telephone / email contact to collect 
the following data:  
• New / combination treatment  
• AE/SAE 
The investigator must also contact the randomized registration system to register information 
about subjects who discontinued study treatment.  
subjects who discontinue study treatment due to reasons other than documented disease 
progression, death, loss to follow-up, or withdrawal of informed consent , tumor assessments must 
continue according to the assessment schedule until BIRC determines disease progression, death, 
loss to follow-up, or withdrawal of informed consent according to RECIST 1.1 .  
3.4.3 Withdrawal from the Study 
Study withdrawal was defined as the time at which a subject permanently stopped receiving 
study treatment for any reason and any further evaluation or follow-up required by the protocol.  
or withdraw informed consent at any time . Withdrawal of informed consent may affect further 
contact with the subject and the collection of follow-up data (e.g., responses to data inquiries). 
Therefore, it is important to ensure accurate documentation of withdrawal from the study and 
discontinuation of study treatment, as defined in the protocol. If a subject requests withdrawal from 
the study, the investigator should make every effort to determine the subject's primary reason for 
withdrawal through various means (e.g., telephone, email, letter) and document this information.  
Once a subject confirms withdrawal from the study, study treatment must be discontinued and 
no further assessments will be performed. Data that should have been collected at subsequent visits 
will be considered missing. No further attempts to contact the subject will be permitted unless 

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safety concerns arise and communication or follow-up is required. If the subject agrees, a final 
assessment will be conducted at the time of withdrawal, as detailed in the Assessment Schedule. 
Subjects who did not complete the study protocol (including cell reinfusion and follow-up 
assessments) were considered to have terminated the study prematurely. 
for withdrawal must be recorded in the CRF and kept within the prescribed time according to 
GCP requirements. 
Reasons for subjects to withdraw from the study included: 
1) The subject died. 
2) The subject was lost to follow-up. 
3) The subject requested to withdraw from the study. 
4) IMC002 preparation failed and is not suitable for re-apheresis (only applicable to the 
experimental group) . 
5) Termination of a project initiated by the sponsor, principal investigator, ethics committee, 
or regulatory agency. 
for withdrawal must be recorded in the CRF and kept within the prescribed time according to 
GCP requirements. 
3.4.4 Lost to follow-up  
If a subject fails to attend study visits or respond to any contact attempts by the research center 
and does not clarify his or her intention to discontinue study treatment or withdraw from the study 
or withdraw informed consent, and thus his or her status cannot be known, the investigator should 
record the steps for contacting the subject in the original documents, such as the date of the phone 
call or registered mail, as a demonstration of due diligence. The subject should not be considered 
lost to follow-up until due diligence is completed. 
4. Study Population 
All subjects in this study must provide their informed consent (ICF) before undergoing any 
study-related procedures. Subjects must meet all the following inclusion criteria and do not meet 
all exclusion criteria to be included. 
4.1 Inclusion Criteria 
1) The age at randomization was at least 18 years old , and both men and women were 
eligible. 
2) histologically or cytologically confirmed inoperable locally advanced or metastatic 
gastric/esophagogastric junction adenocarcinoma who have failed at least two prior lines 
of therapy : 
a. Radiographic progression or clinical worsening of symptoms during second-line 

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treatment (if first-line treatment includes three drugs including taxanes (or anthracyclines), 
platinums, and fluorouracils, and the disease progression is assessed by the investigator, the patient 
may also be enrolled as an eligible subject; disease progression within 6 months after the end of 
neoadjuvant/adjuvant treatment is also considered a first-line treatment failure); 
b. Patients with intolerance to second-line treatment may also be enrolled in the study 
after full evaluation by the investigator. The definition of intolerance to previous treatment is as 
follows: 
 
any Grade ≥ 3 (according to NCI CTCAE v5.0 criteria) hematologic toxicity that 
has not recovered to Grade 1 or pre-treatment levels after 14 days of best supportive 
care; 
 
any Grade ≥ 3 (according to NCI CTCAE v5.0 criteria) non-hematologic toxicity 
(excluding alopecia and asymptomatic laboratory abnormalities) that has not resolved 
after 14 days of best supportive care. 
3) Tumor tissue specimens (primary or metastatic, archived or newly collected) from 
subjects are expected to be available and tested by a central laboratory, indicating positive 
histological staining for CLDN18.2 (defined as a positive tumor cell rate ≥40% and a 
staining intensity ≥2+) . If the subject has previously received other CLDN18.2-targeted 
therapies, tumor tissue specimens collected after that treatment are required to retest and 
evaluate CLDN18.2 expression levels . 
4) The subject's expected survival period is ≥12 weeks. 
5) According to RECIST 1.1, there should be at least one stably measurable target lesion or 
evaluable lesion, and the longest diameter of the largest lesion (or the shortest diameter 
if it is a lymph node lesion) should be ≤5 cm . 
6) ECOG performance status score is 0-1. 
7) The subject must have adequate organ and bone marrow function. Laboratory screening 
must meet the following criteria. All laboratory test results should be within the stable 
ranges described below, and there should be no ongoing supportive treatment. If any 
laboratory test result is abnormal based on the following criteria , the test can be repeated 
within 1 week. If the test results still do not meet the following criteria , the patient has 
failed the screening. 
a) Blood tests [no enhanced blood transfusion ( ≥ 2 times within 1 week), platelet 
transfusion, or cell growth factor (except recombinant erythropoietin) within 7 days 
before the examination]: neutrophil count ≥ 1.5×10 9 /L; platelet count (PLT) ≥ 75×10 
9 /L; hemoglobin content (Hb) ≥ 8.0 g/dL; lymphocyte (LYM) ≥ 0.5×10 9 /L; 
b) Liver 
function: 
alanine 
aminotransferase 
(ALT) 
≤ 
2.5×ULN, 
aspartate 
aminotransferase (AST) ≤ 2.5×ULN, serum total bilirubin (TB) ≤ 2×ULN; for 

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patients with liver metastasis, AST and ALT < 5×ULN; 
c) Renal function: Serum creatinine ≤ 1.5 × ULN. If serum creatinine is > 1.5 × ULN, 
creatinine clearance > 50 mL/min (based on the Cockcroft-Gault formula); 
qualitative urine protein ≤ 1+; if qualitative urine protein is ≥ 2+, a 24-hour urine 
protein quantitative test is required (a 24-hour urine protein quantitative test < 1 g is 
acceptable); 
d) Amylase and lipase ≤ 1.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN. For 
patients with bone metastases, ALP < 5 × ULN. 
8) All toxic reactions caused by previous anti-tumor therapy have been alleviated to Grade 
0-1 (according to NCI CTCAE Version 5.0) or to a level acceptable to the 
inclusion/exclusion criteria. This excludes other toxicities such as alopecia and vitiligo 
that the investigator believes do not pose a safety risk to the subjects. 
9) Reproductive status: Female patients of childbearing age or male patients whose sexual 
partners are female patients of childbearing age are willing to take medically approved 
and highly effective contraceptive measures , such as intrauterine devices or condoms, 
from the time the informed consent is signed until 12 months after cell infusion (female 
patients of childbearing age include premenopausal women and women within 24 months 
of postmenopause). 
10) The subjects must sign and date the written informed consent form. 
11) Subjects must be willing and able to comply with the scheduled treatment regimen, 
laboratory tests, follow-up and other study requirements. 
4.2 Exclusion criteria 
Subjects who meet any of the following conditions will not be included in this study; 
1) Pregnant and breastfeeding women. 
2) Positive human immunodeficiency virus (HIV) antibody test; hepatitis B virus infection 
( HBsAg positive and/or HBc antibody positive, and HBV-DNA positive ); acute or 
chronic active hepatitis C (HCV antibody positive and HCV-RNA positive ); positive 
syphilis antibody test; Epstein-Barr virus infection (IgM positive); cytomegalovirus 
(CMV) infection (IgM positive) ; human T- lymphotropic virus ( HTLV ) positive; 
positive for novel coronavirus (COVID-19) and not reverting to negative within 7 days . 
The above pathogen test results are subject to the central laboratory test results. 
3) Known HER2 expression is positive (defined as IHC 3+, or IHC 2+ and FISH+). 
4) Active or clinically poorly controlled serious infection. 
5) Patients had uncontrollable pleural effusion, pericardial effusion, and ascites before 
enrollment. 

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6) Extensive or diffuse lung metastases or extensive or diffuse liver metastases or extensive 
or diffuse bone metastases . 
7) Blood oxygen saturation is ≤ 95% without oxygen inhalation. 
8) Other serious pulmonary diseases that may limit their participation in this study, such as 
pulmonary embolism, chronic obstructive pulmonary disease, symptomatic or poorly 
controlled interstitial lung disease, or clinically significant abnormalities in pulmonary 
function tests. 
9) Patients with deep and large ulcers of the primary lesion, or recurrence of the anastomotic 
site with tumor infiltration of the entire layer, or tumor lesions infiltrating large blood 
vessels, who are judged by the researchers to be at high risk of bleeding or perforation, 
were included in the CT/MRI or combined gastroscopy examinations. 
10) Patients with known past or current hepatic encephalopathy requiring treatment; patients 
with current or history of central nervous system diseases, such as epileptic seizures, 
cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease 
involving the central nervous system; patients with clinical symptoms of central nervous 
system metastasis or meningeal metastasis, or other evidence indicating that the patient's 
central nervous system metastasis or meningeal metastasis has not been controlled, who 
are judged by the investigator to be unsuitable for inclusion. 
11) unstable heart disease that requires treatment or heart disease that cannot be controlled 
after treatment, or hypertension that is poorly controlled as determined by the researchers 
(defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure > 100 
mmHg after standard antihypertensive drug treatment); or diabetes that is still poorly 
controlled after standard treatment (fasting blood glucose ≥ 10.2 mmol/L). 
12) Any of the following cardiac clinical symptoms or diseases within 6 months before cell 
infusion: 
a) Left ventricular ejection fraction (LVEF) < 50%; 
b) Myocardial infarction within 1 year; or unstable angina; or history of percutaneous 
coronary intervention (PCI) or coronary artery bypass grafting (CABG); use of 
pacemaker; 
c) Resting electrocardiogram (ECG) with QTc F >450 ms (male) or QTc F >470 ms 
(female); 
d) Resting electrocardiogram reveals clinically significant abnormalities (such as 
abnormalities in heart rate, conduction, or morphological characteristics), complete 
left bundle branch block, third- degree atrioventricular block, or a PR interval 
greater than 250 ms. 
13) Evidence of a significant coagulopathy or other significant bleeding risk, including: 

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a) clinically significant coagulation abnormalities; 
b) A history of intracranial hemorrhage or spinal cord hemorrhage; 
c) Patients whose tumor lesions invade large blood vessels and have a significant risk 
of bleeding; 
d) Patients with current unstable or active ulcers or active gastrointestinal bleeding; 
e) An embolic event occurred within 6 months before cell transfusion; 
f) 
Clinically significant hemoptysis or significant bleeding in tumor lesions occurred 
within 1 month before cell transfusion; 
g) Major trauma or major surgery within 1 month before enrollment; 
h) The presence of any bleeding disorders, such as hemophilia, von Willebrand disease, 
etc.; 
i) 
Use of anticoagulant therapy (except low molecular weight heparin) for therapeutic 
purposes within 2 weeks before cell transfusion; 
j) 
Patients are currently receiving conventional anticoagulant therapy (such as 
warfarin or heparin). Patients require long-term antiplatelet therapy (aspirin ≥ 
100 mg/day; clopidogrel ≥ 75 mg/day); dipyridamole, ticlopidine, or cilostazol. 
14) Receipt of systemic steroids equivalent to >15 mg/day of prednisone for more than 3 
days within 2 weeks before apheresis, excluding inhaled steroids. 
15) Subjects requiring systemic treatment with corticosteroids or other immunosuppressive 
drugs during treatment. Subjects with any active autoimmune disease, or a history of 
autoimmune disease with expected recurrence (including but not limited to systemic 
lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory 
bowel disease, and asthma requiring medical intervention with bronchodilators). 
Exceptions include: type 1 diabetes; skin diseases not requiring systemic treatment (e.g., 
vitiligo, psoriasis); alopecia; hypothyroidism requiring only hormone replacement 
therapy; asthma that fully resolved in childhood and does not require any intervention in 
adulthood; or other subjects whose condition is not expected to relapse in the absence of 
external triggers. 
16) Patients with previous or concurrent malignancies, with the following exceptions: 
a) Adequately treated basal cell or squamous cell carcinoma of the skin (adequate 
wound healing was required before study enrollment); 
b) Carcinoma in situ of cervical or breast cancer who has undergone curative treatment 
and has no signs of recurrence for at least 3 years before the study; 
c) The primary malignancy has been completely resected and remains in complete 
remission for ≥ 5 years. 

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17) Subjects who have previously received other gene therapies, including but not limited to 
CAR-T therapy and TCR-T therapy . 
18) Received the following treatments or drugs before cell infusion: received chemotherapy, 
targeted therapy, biological therapy, endocrine therapy, immunotherapy and other anti-
tumor treatments (except for treatments used in accordance with the protocol 
requirements before infusion, such as lymphoproliferative conditioning and bridging 
therapy) , less than 28 days or less than 5 half-lives (whichever is shorter) from the first 
infusion of treatment in this study ; received traditional Chinese medicine treatment with 
anti-tumor indications within 2 weeks before cell infusion. 
19) There is a history of other severe allergies such as anaphylactic shock. 
20) Subjects with severe mental disorders. 
21) If a subject develops a new arrhythmia, including but not limited to arrhythmias that 
cannot be controlled with medication; hypotension requiring pressor medication; or 
bacterial, fungal, or viral infection requiring intravenous antibiotics , the investigator may 
determine that the subject is unsuitable for participation in the trial . Subjects who are 
taking antibiotics to prevent infection may continue to participate in the trial at the 
investigator's discretion. 
22) Participation in other interventional clinical studies and use of study drug within 1 month 
before the planned IMC 002 infusion . 
23) The investigator assesses that the subject is unable or unwilling to comply with the 
requirements of the study protocol. 
24) 4 weeks before the planned apheresis time or plan to receive a live attenuated vaccine 
during the study. 
25) Subjects with gastrointestinal obstruction or obstructive jaundice are deemed unsuitable 
for participation in this trial by the investigator . 
26) Subjects with any other concurrent serious and/or uncontrolled medical conditions who 
are deemed unsuitable for participation in this trial by the investigator. 
4.3 Re-evaluation of subjects before apheresis 
Subjects who are confirmed to be qualified by screening examination can undergo leukocyte 
apheresis. 
Seven days before apheresis, the researcher needs to conduct relevant examinations (if the 
screening examination is no more than 7 days away from the apheresis, there is no need to re-
examine, unless the researcher assesses that there are clear reasons that may cause the test values 
to change during this period) . The patient should be re-evaluated and the subject must meet the 
following criteria: neutrophil count ≥ 1.5×10 9 /L; platelet count PLT ≥ 75×10 9 /L; hemoglobin 
content Hb ≥ 8.0g/dL; lymphocyte LYM ≥ 0.5×10 9 /L. 

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Pre-dose Assessment of Subjects with Lymphatic Clearance Pretreatment 
If the subject meets any of the following criteria before lymphoproliferative pretreatment and 
is judged by the researcher to be unsuitable for subsequent trial procedures, lymphoproliferative 
pretreatment cannot be continued or needs to be delayed , and infusion cannot be performed or 
needs to be delayed. 
1) ECOG performance status score ≥2 points; 
2) Active infection: If the subject requires systemic anti-infective treatment or has a body 
temperature of ≥38°C within 7 days before lymph node clearance pretreatment, the 
investigator must discuss this with the sponsor before starting lymph node clearance 
pretreatment; 
3) Patients are assessed by the investigator to have a high risk of bleeding or perforation; 
4) with known or suspected central nervous system metastasis; 
5) Surgery, interventional therapy, radiotherapy or immunotherapy for the disease 
underwent within 2 weeks before lympholysis pretreatment; 
6) Blood tests: neutrophil count < 1.5×10 9 /L; platelet count (PLT) < 75×10 9 /L; 
hemoglobin content (Hb) < 8.0 g/dL; 
7) Liver function: Alanine aminotransferase (ALT) > 2.5×ULN, aspartate aminotransferase 
(AST) > 2.5×ULN, serum total bilirubin (TB) > 2×ULN; for patients with liver 
metastasis, AST and ALT > 5×ULN; 
8) Renal function: creatinine clearance < 50 mL/min (according to the Cockcroft-Gault 
formula); 
9) Amylase and lipase > 1.5 × ULN; alkaline phosphatase (ALP) > 2.5 × ULN; for patients 
with bone metastases, ALP > 5 × ULN ; 
10) international normalized ratio (INR) and partial prothrombin time (APTT) > 1.5 × ULN; 
11) Oxygen supplementation is required to maintain blood oxygen saturation > 95% 
(referring to pulse oxygen) 
12) Patients who have used systemic glucocorticoids within 7 days before lymph node 
clearance pretreatment and whose cumulative dose exceeds 70 mg of prednisone (except 
those who used inhaled or topical glucocorticoids); 
13) Any toxic reactions caused by bridging therapy have not recovered to CTCAE grade 2 
or below; 
14) failure to complete the bridging therapy washout period; 
15) Other complications or toxicities may place the subject at inappropriate risk for 
lymphoproliferative conditioning and IMC002 cell infusion, including but not limited to 

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the development of new arrhythmias in the subject that cannot be controlled by 
medication; hypotension requiring pressors; the researcher assesses the patient's presence 
of major organ dysfunction ( such as severe heart disease, uncontrolled hypertension or 
diabetes, severe liver or kidney damage, pulmonary edema, severe lung infection, brain 
metastasis, etc. ). If necessary, it is recommended to discuss the matter with the sponsor's 
medical department. 
4.5 Subject Pre-Infusion Assessment 
Before IMC002 infusion, the subject's clinical status should not be significantly worse than 
that at the time of enrollment screening, as assessed by the investigator, which would increase the 
risk of IMC002 infusion. On the scheduled IMC002 infusion day, if the subject meets any of the 
following criteria, IMC002 infusion should be delayed: 
1) ECOG performance status score ≥2 points; 
2) Active infection: If the subject requires systemic anti-infection treatment or has a body 
temperature ≥38°C, the infusion cannot be given or needs to be delayed; 
3) Non-hematologic toxicity of CTCAE grade 3 or higher (excluding grade 3 nausea, 
vomiting, diarrhea, or constipation) occurring after lympholysis pretreatment ; 
4) Oxygen supplementation is required to maintain blood oxygen saturation > 95% 
(referring to pulse oxygen); 
5) Other complications or toxicities may place the subject at inappropriate risk for IMC002 
cell infusion, including but not limited to the subject experiencing new arrhythmias that 
cannot be controlled by medication; hypotension requiring pressors; the researcher 
assesses the patient to have major organ dysfunction (such as severe heart disease, 
uncontrolled hypertension or diabetes, severe liver or kidney damage, pulmonary edema, 
severe lung infection, brain metastasis, etc.). If necessary, it is recommended to discuss 
the medical situation with the sponsor. 
For subjects who have completed cell preparation but do not meet the reinfusion criteria and 
need to delay infusion, if their body temperature does not return to normal within 7 days after the 
lymphatic ablation pretreatment or other toxicity does not recover to ≤ Grade 1, the investigator 
will evaluate whether the subject should receive another lymphatic ablation pretreatment. If for 
any reason the cell infusion is delayed for more than 7 days after the lymphatic ablation 
pretreatment, the infusion cannot be continued, or the investigator will evaluate whether the subject 
should receive another lymphatic ablation pretreatment to delay the infusion. It is recommended 
that the interval between two lymphatic ablations be no less than 4 weeks. 
4.6 Review and rescreening 
If a subject's screening test value fails the test during the first screening, and the researcher 
suspects that it may be caused by non-disease reasons, a maximum of one re-examination of the 

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failed indicator is allowed. 
If a subject fails the initial screening due to an unsatisfactory screening test value, and the 
investigator subsequently determines that the test value may have recovered to meet the 
requirements of this protocol, the subject may be rescreened once. During the rescreening, the 
subject should be assigned a new screening number. 
5. Research therapeutic drugs 
5.1 Basic Information of Study Drug 
The drug used in this study is an autologous T cell injection modified with a chimeric antigen 
receptor targeting CLDN18.2, code-named IMC002 , produced by Suzhou Yimufeng 
Biotechnology Co., Ltd. 
IMC002 is an injection consisting of 0.9% sodium chloride injection, 20% human serum 
albumin (HSA) resuspended in a 3:1 ratio, and then an equal volume of CryoStor® CS10 
cryopreservation solution. The final formulation specification is 30 mL/bag. The CAR-T cell 
content in each bag is shown in Table 2 below . 
Table 2 IMC002 information table 
Number of CAR-T cells per 
patient 
2.5×10 8 
Number of bags per dose 
2 
Number of CAR-T cells per bag 
1.25×10 8 
IMC002 is a cell preparation cryopreserved in liquid nitrogen vapor phase. It is a white to 
reddish, clear to turbid liquid with no visible foreign particles. Storage and transportation 
conditions are liquid nitrogen vapor phase, cryopreserved and transported below -150°C . 
5.2 Packaging and labeling 
5.2.1 Investigational Drug IMC002 
The drug label of IMC002 shall include at least: product name, protocol number, subject 
screening number, subject's initials, the words " For autologous transfusion in clinical research 
only , patient identity must be confirmed before use , cell product, not irradiated" , subject number, 
production batch number, specifications, manufacturer, storage and transportation conditions, 
expiration date, route of administration, etc. 
5.2.2 Bridging drugs, lymphoproliferative pretreatment drugs, and CRS treatment drugs 
Bridging drugs, lymphoproliferative pretreatment drugs, and CRS treatment drugs will 
preferably be available at the research center. If these are not available at the research center, the 
sponsor will purchase them from the manufacturer in commercially available packaging and affix 
a label indicating that they are for clinical research use only. 
5.3 Dosage of the drug 
A single infusion of two bags is used, with a dose of 2.5×10 8 CAR-T cells per subject. The 

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final dose should also take into account the actual number of CAR-T cells produced and record the 
actual number of cells infused. 
5.4 Preparation before reinfusion 
5.4.1 Preparation 
IMC002 is packaged and labeled in a cell infusion bag, with the outer packaging serving as 
the reconstitution bag. After the packaging integrity is verified by the quality department, it is 
stored in a liquid nitrogen vapor phase. Prior to infusion, the product is placed in a vapor phase 
liquid nitrogen tank and transported to the clinical research center at low temperature. If 
reconstitution is acceptable, the liquid nitrogen tank is unpacked and reconstitution is performed. 
If reconstitution is not possible, the liquid nitrogen tank is returned to the manufacturer . 
5.4.2 Reconstitution of cells at the clinical research center 
The frozen product will be transported to the research center in a vapor phase liquid nitrogen 
tank. After receiving the IMC002 product, the clinical research center must review the label 
information, the integrity of the transport packaging, and the transport temperature curve of the 
IMC002 product. Only qualified products will be accepted. Before rethawing, the label information, 
the appearance and integrity of the packaging bag must be reviewed. After confirmation of 
compliance, the product will be rethawed in a warm water bath at 36℃~38℃. The rethawing steps 
are as follows: 
Completely immerse the double-wrapped product in a warm water bath, reconstitute one bag 
at a time, and gently massage the bag until the cells are just thawed. Reconstituted product is 
considered complete when no unthawed clumps remain in the infusion bag. Store the reconstituted 
product at room temperature and infuse as quickly as possible. The time from reconstitution of the 
first bag of cells to the completion of the infusion should not exceed 2 hours. 
5.4.3 Recheck and prepare before re-transfer 
If the outer packaging containing IMC002 is damaged or leaking, but the inner packaging bag 
is confirmed to be intact after careful inspection, it can still be infused. If the cell infusion bag is 
damaged, it should not be returned for infusion and should be destroyed. 
IMC002 is administered intravenously via a transfusion device at the research center. Each 
bag of transfused cells will be labeled " For Autologous Transfusion Only for Clinical Research 
Use " and at least two unique identifiers , such as the subject's initials and screening number . Prior 
to transfusion, two individuals will independently verify all subject information to ensure it is 
correctly matched to the participating subjects. 
Before cell infusion, sufficient backup medications (e.g., at least two doses of tocilizumab) 
should be available, and emergency facilities and equipment should be readily available to provide 
prompt treatment in the event of a severe allergic reaction, severe hypotension, or other emergency. 
Thirty to sixty minutes before cell infusion, investigators may consider pre-treating subjects based 
on clinical experience, such as with antihistamines such as acetaminophen (300–1000 mg orally), 

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promethazine hydrochloride (25 mg intramuscularly), or diphenhydramine ( 20 mg 
intramuscularly) . These medications will be provided by the research hospital pharmacy. 
5.5 Intravenous Infusion and Monitoring 
The subjects will be given the study drugs by researchers at the research center, and the 
researchers will truthfully record the number of cells used in the study product , infusion time, 
special circumstances during the infusion process, etc. based on the cell number and infusion 
conditions on the quality inspection report. 
5.5.1 Reinfusion process  
1) Choose superficial veins suitable for puncture and blood transfusion, and thicker veins 
in the upper limbs are recommended ; 
2) Use disposable blood transfusion sets for reinfusion, and do not mix the infusion lines 
with other drugs ; 
3) Before reinfusion, confirm again that the subject meets the infusion criteria and has no 
infection; 
4) Before reinfusion, drip normal saline intravenously to lubricate the infusion tube. If the 
normal saline solution flows smoothly, replace it with an IMC002 cryopreservation bag 
for reinfusion ; 
5) reconstitution of the first bag of cells to the completion of infusion of IMC002 injection 
should not exceed 2 hours. It is recommended that each bag of cells be infused within 30 
minutes (at a drip rate of approximately 3 mL/minute). If cell fluid leakage occurs during 
the reinfusion process, the reinfusion should be stopped and the remaining product should 
be destroyed as specified in the protocol. 
6) After the reinfusion is completed, at least 50 mL of normal saline should be used to flush 
the cells attached to the wall of the transfusion tube to ensure that as many cells as 
possible are reinfused into the subject's body. The time when the last bag is flushed is 
regarded as the end time of all reinfusions. 
7) If severe infusion reaction occurs during the reinfusion, the reinfusion should be stopped 
immediately and the IMC002 cryopreservation bag should be sealed and kept for 
inspection; 
8) Continuous ECG monitoring should be performed for at least 4 hours from the start of 
the reinfusion to the end of the reinfusion. 
For detailed procedures for reinfusion, please refer to the product manual. If a subject 
experiences an infusion-related reaction during the reinfusion process, the infusion can be 
temporarily stopped or the infusion rate reduced. The specific treatment will be evaluated by the 
investigator. 

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5.5.2 Post-infusion monitoring 
After transfusion, each subject is recommended to be hospitalized for 14 days or the 
researcher may decide the discharge time based on the subject's condition. During hospitalization 
after transfusion , body temperature should be monitored at least twice a day, with at least 8 hours 
between each time. If the body temperature is ≥ 38°C, CRS should be considered. Closely monitor 
for suspected CRS, neurotoxicity or other adverse reaction symptoms, and provide timely and 
appropriate treatment for any adverse conditions. 
IMC002 injection is released for reinfusion based on the results of the rapid sterility test. If 
the pharmacopoeial sterility test report is positive after cell reinfusion , refer to the "Reporting and 
Handling of Positive Sterility Test Reports after Cell Infusion" for handling. 
5.6 Storage, distribution and recycling 
5.6.1 Storage  
IMC002 products for long-term storage will be stored in vapor-phase liquid nitrogen tanks at 
the preparation center. IMC002 for infusion will be transported to the clinical research center in 
vapor-phase liquid nitrogen tanks before infusion, and temporarily stored in vapor-phase liquid 
nitrogen tanks before infusion, with the temperature recorded. 
5.6.2 Reconstitution and Infusion of Investigational Drug 
The clinical research center will record the IMC002 shipping temperature, packaging bag 
appearance, and packaging bag integrity. Reconstitute the cells in a warm water bath at 37±1°C. 
Reconstitute and infuse according to the instructions in Sections 5.4 Pre-infusion Preparation and 
5.5 Intravenous Infusion and Monitoring of this protocol . 
5.6.3 Recall and Destruction of Investigational Drugs 
If the cell infusion bag is damaged, it should not be reinfused and should be destroyed. 
The reasons for recalling IMC002 products include but are not limited to: 
1) Deviations, OOS investigations, adverse drug reaction complaints, stability study results, 
supplementary traditional sterility and mycoplasma testing, etc., indicate that the product 
has quality and safety risks; 
2) The subject's condition is not suitable for infusion; 
3) The subject refused the infusion. 
5.7 Issuance and Receipt, Recovery, and Destruction of Study Drugs 
The management, distribution, and recovery of IMC002 in this trial are the responsibility of 
dedicated personnel. Researchers must ensure that all IMC002 is used only for subjects 
participating in this clinical study, and its usage and dosage comply with the trial protocol. 
Remaining cells are returned to the sponsor, and IMC002 must not be transferred to any non-
clinical study participants. 

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CAR - T cells should be cryopreserved at or below -150°C until thawed for use. Upon receipt 
of IMC002 cells, a two-signature cell receipt form must be signed. The clinical research unit will 
retain the original, while the collaborating unit will retain a scanned copy. The issuance and receipt 
of each IMC002 cell should be promptly recorded on a dedicated record sheet. 
Any unused IMC002 or cells suspected of quality issues requiring analysis will be returned 
to the sponsor in a vapor phase liquid nitrogen tank, which will then organize analysis or 
destruction. Entire bags of IMC002 that do not need to be returned to the sponsor, as well as the 
post-infusion cell product bag, infusion tubing, and any other items that came into contact with the 
product, will be disposed of in accordance with the waste management regulations for medical 
institutions. 
5.8 Control Group Drugs 
Comparator drugs, i.e., apatinib mesylate, paclitaxel alone, docetaxel alone, or irinotecan 
alone, are preferably drugs with gastric cancer indications in the instructions , or selected by the 
investigator based on clinical practice and the patient's previous medication history. Dose 
adjustment is allowed based on the subject's tolerance. The trial center is responsible for the storage 
and distribution of the drugs, and the investigator will conduct safety and efficacy assessments on 
the subjects according to the established visits. 
5.8.1 Principles of Dose Adjustment and Discontinuation 
If a subject experiences a drug-related adverse event that is clinically significant and has not 
recovered to CTCAE ≤ Grade 1 or baseline before the next dose, medication may be suspended 
for up to 14 days (calculated based on the scheduled date of medication). "Clinically significant" 
and "related" are based on the investigator's judgment. For example, hair loss may be determined 
to be drug-related, but may not be evaluated as clinically significant. When clinically significant 
toxicity related to the study drug recovers to Grade 1 or baseline, the subject may continue to use 
the study drug. During the recovery period, changes in toxicity should be evaluated weekly. The 
subject's continued medication should maintain the same dose or reduce the dose according to the 
instructions of the control group drug, or the dosage can be adjusted according to the subject's 
specific situation. 
If the subject still experiences clinically significant drug-related adverse events after the dose 
is reduced and does not recover to a level that allows continued dosing within 14 days (calculated 
based on the scheduled medication time), the subject is assessed as intolerant to ICT drug treatment 
and is advised to terminate treatment. 
5.9 Prohibited Drugs and Concomitant Medications 
5.9.1 Contraindicated concomitant therapy 
During treatment, any anti-tumor treatment not specified in the study protocol is not permitted, 
including radiotherapy (except for local palliative radiotherapy), chemotherapy, anti-tumor 
Chinese medicine, immunotherapy, surgical treatment, and other anti-tumor treatments (except for 

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bridging treatment permitted in the study protocol). Immunostimulants, including interferon, 
thymosin, injectable RNA, lentinan, and ganoderma lucidum polysaccharide, are not permitted 
during IMC002 treatment (as they can enhance the immune system's ability to phagocytose and 
kill CAR-T cells). 
corticosteroids exceeding 10 mg/day of prednisone or equivalent is prohibited except for the 
management or prevention of adverse events . 
live or live attenuated vaccines during treatment and within 2 years of IMC002 infusion . 
Subjects receiving IMC002 cell infusion should avoid using drugs that may damage the 
gastric mucosa and cause a higher incidence of gastrointestinal bleeding: non-steroidal anti-
inflammatory drugs, glucocorticoids, antiplatelet/anticoagulant drugs, etc. 
5.9.2 Permitted concomitant treatment 
This study allows the use of medications solely for supportive care (e.g., antipyretics, 
analgesics, antibiotics, antiemetics, antidiarrheals, hepatoprotective drugs, emergency medications, 
and medications for adverse events). Blood products are also permitted. Transfusion-associated 
graft-versus-host 
disease 
(TA-GVHD) 
(an 
immune 
response 
in 
which 
transfused 
immunocompetent lymphocytes attack and destroy host cells and tissues) has been reported in 
subjects receiving fludarabine after transfusion of non-irradiated blood. This condition, which can 
be fatal, is associated with a risk of TA-GVHD. To reduce the risk of TA-GVHD, all blood 
transfusions (including platelets, whole blood, and red blood cells) during study treatment and for 
three months after FNC conditioning should be irradiated. If irradiation is not feasible due to 
specific circumstances, transfusions should be performed using an leukolytic transfusion set. 
Hypotension may occur during cell reinfusion. Therefore, subjects who have previously used 
antihypertensive drugs may consider suspending the use of antihypertensive drugs within 12 hours 
before reinfusion, and closely monitor the subject's blood pressure. 
The 3 days before IMC002 infusion and 4 weeks after IMC002 infusion are a period of close 
observation, and the prophylactic use of proton pump inhibitors and gastric mucosal protective 
agents is recommended. 
In addition to the treatment according to the study protocol, if the subject has disease 
progression (PD), the subject is discharged from the group and the researcher may adopt any 
appropriate treatment plan. 
to the initial signing of the principal informed consent form until the end of the study should 
be recorded (excluding infusion solutions, flushing solutions, softeners, excipients, etc. used in 
routine clinical procedures). The following concomitant medication information should be 
recorded in the original medical record and entered into the electronic case report form: generic 
name, route of administration, method of administration, start date, end date, and indication. Any 
dose adjustment of concomitant medications or changes in treatment regimens must be recorded. 
At each post-dosing visit, the investigator will ask the subject about their concomitant medication 

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Plan version number / version date: V2.1 / September 27, 2025 
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use, and this information should be recorded in the original medical record and entered into the 
electronic case report form. 
6. Study process and visit arrangements 
6.1 Research Process 
The specific process of this study is shown in the table below .

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surface 3. Study flow chart of experimental groups 
Study period / 
visit 
Mole
cular 
pre-
scree
ning 
phase 
Screen
ing 
Period 
1 
Single 
samplin
g 2 
Drainage 
pretreatment 
 
28 days after infusion 
Main follow-up period 
Follo
w-up 
Exit 
Treat
ment 
Visit 
13 
Survi
val 
visit 
Pre-
drainag
e 
assessm
ent 3 
Clearin
g the 
bowels 
Before 
infusion 
Assessm
ent 4 
Infusi
on 
Follow-up within 28 days after infusion 
 
 
 
 
Visit time 
~D42 D-42~ 
D-1 
D0 
Before 
shower 
7 days 
D infusion 
-5d~ - 
3d 
D infusion 
- 1 day 
D 
infusion 
D 
infusion 
+ 1d 
D 
infusio
n + 
3d 
D 
infusion 
+ 7d 
D 
infusion 
+ 9 
days 
D 
infusion 
+ 14d 
D 
infusion 
+ 21d 
D 
infusion 
+ 28d 
W8 
W14 
W20 
W26 
W32 
W38 
W44 
W50 W56~ 
12 
 
Ever
y 12 
week
s 
Time Window 
 
 
+3 days 
 
 
 
 
 
±1d 
 
 
±2d 
±2d 
±2d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
+ 7d ±14d 
Sign 
the 
molecular pre-
screening 
informed 
consent form 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sign 
the 
informed 
consent form 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Excl
usion Criteria 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographic 
data 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tumor 
diagnosis and 
treatment 
history 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tumor staging 
and pathology 
during 
screening 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
History of non- 
study illnesses 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study period / 
visit 
Mole
cular 
pre-
scree
ning 
phase 
Screen
ing 
Period 
1 
Single 
samplin
g 2 
Drainage 
pretreatment 
 
28 days after infusion 
Main follow-up period 
Follo
w-up 
Exit 
Treat
ment 
Visit 
13 
Survi
val 
visit 
Pre-
drainag
e 
assessm
ent 3 
Clearin
g the 
bowels 
Before 
infusion 
Assessm
ent 4 
Infusi
on 
Follow-up within 28 days after infusion 
 
 
 
 
Visit time 
~D42 D-42~ 
D-1 
D0 
Before 
shower 
7 days 
D infusion 
-5d~ - 
3d 
D infusion 
- 1 day 
D 
infusion 
D 
infusion 
+ 1d 
D 
infusio
n + 
3d 
D 
infusion 
+ 7d 
D 
infusion 
+ 9 
days 
D 
infusion 
+ 14d 
D 
infusion 
+ 21d 
D 
infusion 
+ 28d 
W8 
W14 
W20 
W26 
W32 
W38 
W44 
W50 W56~ 
12 
 
Ever
y 12 
week
s 
Time Window 
 
 
+3 days 
 
 
 
 
 
±1d 
 
 
±2d 
±2d 
±2d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
+ 7d ±14d 
/allergies/curre
nt 
medical 
conditions 
Previous non-
study 
disease 
treatment 5 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Claudin 
18.2 
Detection 6 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECOG score 
 
X 
 
X 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Vital signs 
 
X 
 
X 
X 
X 
X 20 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Physical 
examination 
 
X 
 
 
 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Blood oxygen 
saturation 
 
X 
 
 
 
X 
 
X 
X 20 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Height 
/body 
surface area 
 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
weight 
 
X 
 
X 
 
 
 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Complete 
blood count 
 
X 
X 
X 
 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Urinalysis 
 
X 
 
X 
 
 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 74 NUMPAGES  
 
Study period / 
visit 
Mole
cular 
pre-
scree
ning 
phase 
Screen
ing 
Period 
1 
Single 
samplin
g 2 
Drainage 
pretreatment 
 
28 days after infusion 
Main follow-up period 
Follo
w-up 
Exit 
Treat
ment 
Visit 
13 
Survi
val 
visit 
Pre-
drainag
e 
assessm
ent 3 
Clearin
g the 
bowels 
Before 
infusion 
Assessm
ent 4 
Infusi
on 
Follow-up within 28 days after infusion 
 
 
 
 
Visit time 
~D42 D-42~ 
D-1 
D0 
Before 
shower 
7 days 
D infusion 
-5d~ - 
3d 
D infusion 
- 1 day 
D 
infusion 
D 
infusion 
+ 1d 
D 
infusio
n + 
3d 
D 
infusion 
+ 7d 
D 
infusion 
+ 9 
days 
D 
infusion 
+ 14d 
D 
infusion 
+ 21d 
D 
infusion 
+ 28d 
W8 
W14 
W20 
W26 
W32 
W38 
W44 
W50 W56~ 
12 
 
Ever
y 12 
week
s 
Time Window 
 
 
+3 days 
 
 
 
 
 
±1d 
 
 
±2d 
±2d 
±2d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
+ 7d ±14d 
Stool 
routine 
and 
occult 
blood test 
 
X 
 
X 
 
 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Blood 
biochemistry 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Coagulation 
function 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Amylase 
and 
lipase 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
C-reactive 
protein 
 
X 
 
X 
 
 
 
X 
X 
X 
 
X 
X 
X 
X 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 14 ( X ) 
14 
X 
 
Peripheral 
blood ferritin 
 
X 
 
X 
 
 
 
X 
X 
X 
 
X 
X 
X 
X 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 14 ( X ) 
14 
X 
 
Pregnancy test 
7 
 
X 
 
According to clinical signs, if women of childbearing age who are fertile experience amenorrhea, morning sickness, abdominal pain, vaginal bleeding, or 
other symptoms suspected of pregnancy, they should be reviewed promptly. 
 
 
fasting 
blood 
sugar 
 
X 
 
Diabetic patients should undergo timely review according to clinical needs 
 
 
Infectious 
disease 
examination 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Gastroscopy 8 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 75 NUMPAGES  
 
Study period / 
visit 
Mole
cular 
pre-
scree
ning 
phase 
Screen
ing 
Period 
1 
Single 
samplin
g 2 
Drainage 
pretreatment 
 
28 days after infusion 
Main follow-up period 
Follo
w-up 
Exit 
Treat
ment 
Visit 
13 
Survi
val 
visit 
Pre-
drainag
e 
assessm
ent 3 
Clearin
g the 
bowels 
Before 
infusion 
Assessm
ent 4 
Infusi
on 
Follow-up within 28 days after infusion 
 
 
 
 
Visit time 
~D42 D-42~ 
D-1 
D0 
Before 
shower 
7 days 
D infusion 
-5d~ - 
3d 
D infusion 
- 1 day 
D 
infusion 
D 
infusion 
+ 1d 
D 
infusio
n + 
3d 
D 
infusion 
+ 7d 
D 
infusion 
+ 9 
days 
D 
infusion 
+ 14d 
D 
infusion 
+ 21d 
D 
infusion 
+ 28d 
W8 
W14 
W20 
W26 
W32 
W38 
W44 
W50 W56~ 
12 
 
Ever
y 12 
week
s 
Time Window 
 
 
+3 days 
 
 
 
 
 
±1d 
 
 
±2d 
±2d 
±2d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
+ 7d ±14d 
12-lead 
electrocardiogr
am 
 
X 
 
X 
 
X 
X 11 
X 11 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
echocardiograp
hy 
 
X 
 
Based on clinical signs, if symptoms or signs suggestive of heart failure occur, a follow-up examination should be conducted promptly. 
 
 
 
Tumor markers 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Imaging 
examination9 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Tumor 
Assessment10 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Random 2 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Leukocyte 
apheresis 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lymph 
effusion 
pretreatment 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IMC002 
Feedback 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CAR 
copy 
number 15 
 
 
 
X 
 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
 
 
 
X 
X 
X 
 
CAR-T cells 
Subgroup/Phen
otype 15 
 
 
 
X 
 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
 
 
 
X 
X 
X 
 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 76 NUMPAGES  
 
Study period / 
visit 
Mole
cular 
pre-
scree
ning 
phase 
Screen
ing 
Period 
1 
Single 
samplin
g 2 
Drainage 
pretreatment 
 
28 days after infusion 
Main follow-up period 
Follo
w-up 
Exit 
Treat
ment 
Visit 
13 
Survi
val 
visit 
Pre-
drainag
e 
assessm
ent 3 
Clearin
g the 
bowels 
Before 
infusion 
Assessm
ent 4 
Infusi
on 
Follow-up within 28 days after infusion 
 
 
 
 
Visit time 
~D42 D-42~ 
D-1 
D0 
Before 
shower 
7 days 
D infusion 
-5d~ - 
3d 
D infusion 
- 1 day 
D 
infusion 
D 
infusion 
+ 1d 
D 
infusio
n + 
3d 
D 
infusion 
+ 7d 
D 
infusion 
+ 9 
days 
D 
infusion 
+ 14d 
D 
infusion 
+ 21d 
D 
infusion 
+ 28d 
W8 
W14 
W20 
W26 
W32 
W38 
W44 
W50 W56~ 
12 
 
Ever
y 12 
week
s 
Time Window 
 
 
+3 days 
 
 
 
 
 
±1d 
 
 
±2d 
±2d 
±2d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
+ 7d ±14d 
Cytokine 15 
 
 
 
 
X 
 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
 
 
 
X 
 
X 
 
Immunogenicit
y testing16 
 
 
 
X 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
X 
 
 
 
X 
X 
X 
 
RCL detection 
17 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
 
 
X 
X 
X 
 
Lentiviral 
genome 
Insertion site 18 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
 
 
X 
X 
X 
 
Exploratory 
indicator 
testing 
X 
 
 
 
 
 
 
 
Based on the actual clinical sample availability and visit points, the researcher will decide whether to conduct 
an exploratory study with informed consent. 
 
 
Combination 
drug /non-drug 
treatment 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
EORTC 
Quality of Life 
Scale 19 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Adverse event 
records 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Living 
conditions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Antitumor 
therapy 
after 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 77 NUMPAGES  
 
Study period / 
visit 
Mole
cular 
pre-
scree
ning 
phase 
Screen
ing 
Period 
1 
Single 
samplin
g 2 
Drainage 
pretreatment 
 
28 days after infusion 
Main follow-up period 
Follo
w-up 
Exit 
Treat
ment 
Visit 
13 
Survi
val 
visit 
Pre-
drainag
e 
assessm
ent 3 
Clearin
g the 
bowels 
Before 
infusion 
Assessm
ent 4 
Infusi
on 
Follow-up within 28 days after infusion 
 
 
 
 
Visit time 
~D42 D-42~ 
D-1 
D0 
Before 
shower 
7 days 
D infusion 
-5d~ - 
3d 
D infusion 
- 1 day 
D 
infusion 
D 
infusion 
+ 1d 
D 
infusio
n + 
3d 
D 
infusion 
+ 7d 
D 
infusion 
+ 9 
days 
D 
infusion 
+ 14d 
D 
infusion 
+ 21d 
D 
infusion 
+ 28d 
W8 
W14 
W20 
W26 
W32 
W38 
W44 
W50 W56~ 
12 
 
Ever
y 12 
week
s 
Time Window 
 
 
+3 days 
 
 
 
 
 
±1d 
 
 
±2d 
±2d 
±2d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
+ 7d ±14d 
study treatment 
discontinuation 
Note: 
1. Subjects must complete all required visits according to the visit schedule during the screening period. The primary and subsequent follow-up visits are calculated based 
on the randomization date (D0). Pre-infusion extensions due to CAR-T cell preparation, bridging therapy, or other factors will not be recorded as protocol deviations. If 
necessary, screening examinations may be performed concurrently with molecular screening . In this case, patients must sign both the molecular pre-screening informed 
consent form and the primary informed consent form. 
2. The date of randomization is designated as D0. Subjects randomized into the trial group will undergo apheresis on the day of randomization or the day following, after 
the investigators have initially assessed their eligibility. Routine blood test results, if available within 7 days prior to leukocyte apheresis, can be used to assess the safety 
and standard of apheresis . If the last routine blood test has been performed more than 7 days prior to leukocyte apheresis, or if the investigators determine that the 
subject's hematological parameters may have changed, a routine blood test should be performed within 7 days prior to apheresis . 
3. Within 7 days before the lymph node clearance pretreatment, the researcher will conduct another examination based on the subject's disease condition, including but 
not limited to: routine examination and occult blood in blood, urine and stool, blood biochemistry, pancreatic function, coagulation function, electrocardiogram, etc. 
Subjects judged by the researcher to be in a qualified condition will undergo lymph node clearance pretreatment. 
4. Prior to cell reinfusion, the investigator must re-evaluate the subject. Only subjects who meet the cell reinfusion criteria may undergo the infusion. If the subject does 
not meet the cell reinfusion criteria, the infusion may be delayed for no more than 7 days . If the delay exceeds 7 days , the investigator will assess whether the subject 
should undergo a repeat baseline examination and lymphadenopathy pretreatment procedure. Following cell reinfusion, the subject is recommended to remain hospitalized 
for 14 days, or the investigator may determine the discharge date based on the subject's condition. Extended hospitalization due to standard medical procedures will not 
be recorded as a SAE. 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 78 NUMPAGES  
 
5. All medications (including nutritional supplements such as vitamins, therapeutic solvents or solvents) and non-drug treatments used within 30 days before the first 
signing of the principal informed consent form should be recorded. 
6. Potentially eligible subjects will sign the molecular pre-screening informed consent form and undergo CLDN18.2 target screening and related molecular biological 
characterization testing. Subjects are required to provide a tumor tissue specimen (paraffin block or section). If a tumor tissue specimen is unavailable, a biopsy will be 
performed during the molecular pre-screening period for central laboratory screening of CLDN18.2 expression. Sample requirements include: formalin-fixed, paraffin-
embedded tumor tissue block (paraffin blocks within 2 years are acceptable), fresh biopsy tissue, or at least 6-10 freshly cut, 4-5 μm thick, unstained tissue sections. 
7. Blood pregnancy tests are only for female subjects of childbearing age who are fertile. Urine or blood pregnancy tests may be performed during the study if deemed 
necessary by the investigator. Testing should be performed during the screening period. Women of childbearing age include premenopausal women and women within 
24 months of menopause. Infertile women are defined as: 1. Postmenopausal women (amenorrhea for at least one year); 2. Women who have undergone bilateral 
oophorectomy or hysterectomy. 
8. Gastroscopy is required during the screening period. For subjects who have undergone total gastrectomy, the researcher will determine whether gastroscopy is necessary. 
9. ① Imaging examinations include enhanced MRI of the head, enhanced CT or MRI of the chest, abdomen, and pelvis , and bone scan results (if bone metastases or 
signs of bone metastases are present). Subjects with contrast agent allergies may undergo conventional CT /MRI examinations . Enhanced MRI of the head is mandatory 
during the screening period and optional during the follow-up period at the investigator's discretion if no abnormalities are present . ② Imaging examinations required 
for enrollment assessments may be performed within 28 days prior to signing the primary informed consent form. Additionally, an imaging assessment must be performed 
within 14 days prior to randomization as the baseline for this study . ③ During the primary and subsequent follow-up periods, enhanced CT or MRI imaging 
examinations will be performed according to the trial schedule. Based on the subject's clinical signs, if a subject is suspected of achieving complete remission or disease 
progression, the investigator may determine whether to increase the frequency of testing based on actual circumstances . ④ The examination methods for the same 
subject and the same site during the baseline and follow-up periods should remain consistent . 
10. Tumor Assessment: Imaging assessment within 14 days before randomization served as the baseline of this study. Starting from the post-randomization apheresis, 
the first tumor assessment was performed at 8 weeks ± 7 days (the trial group must also meet the requirement of at least 4 weeks after infusion). Tumor assessments 
were performed every 6 weeks ± 7 days thereafter until disease progression was determined by the investigator and confirmed by BIRC, or the patient started new anti-
tumor treatment, died, was lost to follow-up, or withdrew from the study, whichever occurred first. 
on the infusion day and 1 day after infusion are not required . 
1 2. After W56 (inclusive), return to the research center for relevant examinations every 6 weeks, with a visit window period of ±7 days, until PD, death, or withdrawal 
from the trial (whichever occurs first). 
13. If a subject withdraws from treatment for any reason, the withdrawal visit will be completed within 7 days of withdrawal and before starting any new anti-cancer 
treatment. Subjects who have completed the required assessment within 7 days before withdrawal do not need to undergo a repeat examination. Imaging examinations 
that have already been performed within 4 weeks and do not require reconfirmation do not need to be repeated (if a corresponding safety follow-up examination has been 
performed during this period, a repeat examination is not required). 
14. Researchers may decide whether to conduct this test based on actual circumstances . 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 79 NUMPAGES  
 
15. Blood samples for CAR copy number, CAR-T cell subsets/phenotypes, and cytokines were collected before lymphoblastic effusion (within 7 days), before cell 
infusion after lymphoblastic effusion (D infusion -1), 30 minutes ± 5 minutes after cell infusion on the infusion day, 3 days, 7 days, 9 days, 14 days, 28 days, W8 after 
randomization, W14 (± 7 days), W26 (± 7 days), W50 (± 7 days), W98 (± 7 days), and at the exit visit. Blood samples were collected every 6 months for 2 years 
after cell infusion. Blood samples were collected until disease progression, two consecutive undetectable CAR copy numbers after peak detection, death, or other reasons 
for patient withdrawal from the study (whichever occurred first). 
16. Immunogenicity testing will be performed at the pre-lympholysis assessment (within 7 days), 28 days after cell infusion, 14 weeks after randomization, 26 weeks 
after randomization, 50 weeks after randomization, 98 weeks after randomization, and at the exit visit. If the CAR copy number is still detectable in peripheral blood 2 
years after cell infusion, then it will be tested every 6 months thereafter. No further testing will be performed after week 14 if the CAR copy number is undetectable for 
two consecutive times (including testing before week 14), in the event of death, withdrawal of informed consent, 15 years after cell infusion, or trial termination (whichever 
occurs first). 
17. RCL testing should be performed before lymphoblastic leukemia cell infusion (D Infusion -1) , at 14, 26, 50, and 98 weeks after randomization, and annually for 2 years 
after cell infusion until the subject is lost to follow-up, dies, withdraws informed consent, 15 years after cell infusion, or trial termination (whichever occurs first). If the 
RCL test is negative within 26 weeks after randomization and there are no clinical signs of abnormal lentiviral expansion, blood samples collected after 26 weeks can be 
retained and not tested. 
18. The time points for lentiviral genome insertion site detection are before cell infusion after lympholysis (D infusion -1) , 14 weeks , 26 weeks, 50 weeks and 98 weeks 
after randomization and the exit visit , and once a year after 2 years of cell infusion until the subject is lost to follow-up, dies, withdraws informed consent, 15 years after 
cell infusion or trial termination (whichever occurs first). 
19. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OG25 questionnaires: Assessments were performed during the screening 
period, 8 weeks ± 7 days after randomization, and every 6 weeks ± 7 days thereafter until the patient started new anti-tumor treatment, died, was lost to follow-up, 
or withdrew from the study, whichever occurred first. 
20. Physical examination and blood oxygen saturation: Monitor within 1 hour before infusion and within 1 hour after infusion. Additional monitoring may be performed 
after infusion at the investigator's discretion. 
 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 80 NUMPAGES  
 
surface 4. Control group study flow chart (apatinib mesylate/paclitaxel monotherapy) 
Study period/visit 
Molecular 
pre-
screening 
phase 
Screening 
Period 1 
Single 
sampling 
2 
Treatment period 
Exit Treatment 
Visit 9 
Survival 
follow-up 
C1 (28 days) 
C2 (28 days) 
Subsequent 
treatment cycle 12 
Visit time 
~D42 
D-42~D-1 
D0 
D1 
D 8 
D 15 
D1 
D 8 
D 15 
D1 
D 8 
D 15 
 
Every 12 
weeks 
Time Window 
 
 
± 3 days  
± 3 
days 
± 3 
days  
± 3 
days 
± 3 
days 
 
± 3 
days 
± 3 days 
Within 30 days 
after the last dose 
±14d 
Sign the molecular 
pre-screening 
informed 
consent 
form 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sign the informed 
consent form 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
Criteria 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographic data 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Tumor diagnosis and 
treatment history 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Tumor classification 
and staging during 
screening 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
History of non- study 
illnesses 
/allergies/current 
medical conditions 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Previous treatment 3 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Claudin 
18.2 
Detection 4 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECOG score 
 
X 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Vital signs 
 
X 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Physical examination 
 
X 
 
X 
 
 
X 
 
 
X 
 
 
X 
 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 81 NUMPAGES  
 
Study period/visit 
Molecular 
pre-
screening 
phase 
Screening 
Period 1 
Single 
sampling 
2 
Treatment period 
Exit Treatment 
Visit 9 
Survival 
follow-up 
C1 (28 days) 
C2 (28 days) 
Subsequent 
treatment cycle 12 
Visit time 
~D42 
D-42~D-1 
D0 
D1 
D 8 
D 15 
D1 
D 8 
D 15 
D1 
D 8 
D 15 
 
Every 12 
weeks 
Time Window 
 
 
± 3 days  
± 3 
days 
± 3 
days  
± 3 
days 
± 3 
days 
 
± 3 
days 
± 3 days 
Within 30 days 
after the last dose 
±14d 
Blood 
oxygen 
saturation 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Height/body surface 
area 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
weight 
 
X 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Complete 
blood 
count 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Urinalysis 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Stool 
routine 
and 
occult blood test 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Blood biochemistry 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Coagulation function 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Amylase and lipase 
 
X 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
C-reactive protein 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Peripheral 
blood 
ferritin 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy test 5 
 
X 
According to clinical signs, if women of childbearing age who are fertile experience 
amenorrhea, morning sickness, abdominal pain, vaginal bleeding, or other symptoms 
suspected of pregnancy, they should be reviewed promptly. 
 
 
fasting blood sugar 
 
X 
 
Diabetic patients should undergo timely review according to clinical needs 
 
Infectious 
disease 
examination 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Gastroscopy 6 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead 
electrocardiogram 
 
X 
 
X 
 
 
X 
 
 
X 
 
 
X 
 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 82 NUMPAGES  
 
Study period/visit 
Molecular 
pre-
screening 
phase 
Screening 
Period 1 
Single 
sampling 
2 
Treatment period 
Exit Treatment 
Visit 9 
Survival 
follow-up 
C1 (28 days) 
C2 (28 days) 
Subsequent 
treatment cycle 12 
Visit time 
~D42 
D-42~D-1 
D0 
D1 
D 8 
D 15 
D1 
D 8 
D 15 
D1 
D 8 
D 15 
 
Every 12 
weeks 
Time Window 
 
 
± 3 days  
± 3 
days 
± 3 
days  
± 3 
days 
± 3 
days 
 
± 3 
days 
± 3 days 
Within 30 days 
after the last dose 
±14d 
echocardiography 
 
X 
 
Based on clinical signs, if symptoms or signs suggestive of heart failure occur, a 
follow-up examination should be conducted promptly. 
 
 
Tumor markers 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
X 
 
Imaging examination7 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
X 
 
Tumor Assessment8 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
X 
 
Random 2 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Leukocyte apheresis 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Control 
group 
treatment 10 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Concomitant 
medication 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
EORTC Quality of 
Life Scale 11 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
Recording 
adverse 
events 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Living conditions 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Other 
anti-tumor 
treatments 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Note: 
1. Subjects must complete all required visits according to the visit schedule during the screening period. The primary and subsequent follow-up visit windows are 
calculated based on the randomization day (D0). If necessary, screening tests can be performed simultaneously with molecular screening tests . In this case, patients must 
sign both the molecular pre-screening informed consent form and the primary informed consent form. 
2. The date of randomization is designated as D0. Subjects randomized into the trial group will undergo apheresis on the day of randomization or the day following, after 
the investigators have initially assessed their eligibility. Routine blood test results, if available within 7 days prior to leukocyte apheresis, can be used to assess the safety 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 83 NUMPAGES  
 
and standard of apheresis. If the last routine blood test has been performed more than 7 days prior to leukocyte apheresis, or if the investigators determine that the subject's 
hematological parameters may have changed, a routine blood test should be performed within 7 days prior to apheresis . 
3. All medications (including nutritional supplements such as vitamins, therapeutic solvents or solvents) and non-drug treatments used within 30 days before the first 
signing of the principal informed consent form should be recorded. 
4 . Potentially eligible subjects will sign the molecular prescreening informed consent form and undergo CLDN18.2 target screening and related molecular biological 
characterization tests. Subjects are required to provide a tumor tissue specimen (paraffin block or section). If a tumor tissue specimen is unavailable, a biopsy will be 
performed during the molecular prescreening period for central laboratory screening of CLDN18.2 expression. Sample requirements include: formalin-fixed, paraffin-
embedded tumor tissue block (paraffin blocks within 2 years are acceptable), fresh biopsy tissue, or at least 6-10 freshly cut, 4-5 μm thick, unstained tissue sections. 
5. Blood pregnancy tests are only applicable to female subjects of childbearing age who are fertile. Urine or blood pregnancy tests may be performed during the study if 
deemed necessary by the investigator. Testing should be performed during the screening period. Women of childbearing age include premenopausal women and women 
within 24 months of menopause. Infertile women are defined as: 1. Postmenopausal women (menopause for at least one year); 2. Women who have undergone bilateral 
oophorectomy or hysterectomy. 
6. Gastroscopy is required during the screening period . For subjects who have undergone total gastrectomy, the researcher will determine whether gastroscopy is necessary. 
7. ① Imaging examinations include enhanced MRI of the head, enhanced CT or MRI of the chest, abdomen, and pelvis, and bone scan results 
(if bone metastases or signs of bone metastases are present). Subjects with contrast agent allergies may undergo conventional CT/MRI 
examinations. Enhanced MRI of the head is mandatory during the screening period and optional during the follow-up period at the 
investigator's discretion if no abnormalities are present. ② Imaging examinations required for enrollment assessments can be performed 
within 28 days prior to signing the informed consent form. Additionally, an imaging assessment must be performed within 14 days prior 
to randomization as the baseline for this study. ③ During the primary and subsequent follow-up periods, enhanced CT or MRI imaging 
examinations will be performed according to the trial schedule. Based on the subject's clinical signs, if the subject is suspected of 
achieving CR or disease progression, the investigator may determine whether to increase the frequency of testing based on actual 
circumstances. ④ The examination methods for the same subject and the same site during the baseline and follow-up periods should remain 
consistent. 
8. Tumor Assessment: Imaging assessment within 14 days before randomization served as the baseline of this study. Starting from the single collection after randomization, 
the first tumor assessment was performed at 8 weeks ± 7 days, and then every 6 weeks ± 7 days until disease progression was determined by the investigator and 
confirmed by BIRC, or the patient started new anti-tumor treatment, died, was lost to follow-up, or withdrew from the study, whichever occurred first. 
9. If a subject withdraws from treatment for any reason, the withdrawal visit will be completed within 30 days of the last dose and before starting any new anti-cancer 
therapy. If the subject has completed the required assessment within 7 days before withdrawal, no repeat examination is required. Imaging examinations that have been 
performed within 4 weeks and do not require reconfirmation do not need to be repeated (if the corresponding safety follow-up examination has been performed during 
this period, the examination does not need to be repeated). 
10. Apatinib mesylate: 850 mg, orally, once a day; paclitaxel: 80 mg/m 2 , intravenous drip, on day 1, day 8, day 15, repeated every 28 days. 

Protocol number: IMC002-RT02-RCT 
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Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 84 NUMPAGES  
 
11. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OG25 questionnaires : Assessments were performed during the screening 
period, 8 weeks ± 7 days after randomization, and every 6 weeks ± 7 days thereafter until the patient started new anti-tumor treatment, died, was lost to follow-up, 
or withdrew from the study, whichever occurred first. 
12. During subsequent treatment cycles, physical examination, vital signs, ECOG score, blood routine test, and blood biochemistry test should be performed within 3 
days before the first medication of each cycle. Coagulation function, C-reactive protein, urine routine test, stool routine test and occult blood test, blood oxygen saturation, 
and electrocardiogram test should be performed within 3 days before the first medication of every 2 treatment cycles (i.e., the 3rd, 5th, 7th, and 9th cycles, and so on). 
 
 

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Version number / version date: V2.1 / September 27, 2025 
Page 81 85 NUMPAGES  
 
surface 5. Control group study flow chart (docetaxel alone) 
Study period/visit 
Molecular pre-
screening phase 
Screening 
Period 1 
Single 
sampling 
2 
Treatment period 
Exit Treatment 
Visit 10 
Survival follow-
up 
C1 (21 days) 
C2 (21 days) 
Subsequent 
treatment 
cycle 12 
Visit time 
~D42 
D-42~D-1 
D0 
D1 
D 8 
D1 
D 8 
D1 
 
Every 12 weeks 
Time Window 
 
 
± 3 days 
 
± 3 days 
 
± 3 days 
 
Within 30 days 
after the last dose 
±14d 
Sign the molecular pre-
screening 
informed 
consent form 
X 
 
 
 
 
 
 
 
 
 
Sign 
the 
informed 
consent form 
 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
Criteria 
 
X 
 
 
 
 
 
 
 
 
Demographic data 
X 
X 
 
 
 
 
 
 
 
 
Tumor 
diagnosis 
and 
treatment history 
 
X 
 
 
 
 
 
 
 
 
Tumor classification and 
staging during screening 
 
X 
 
 
 
 
 
 
 
 
History 
of 
non-study 
illnesses/allergies/current 
medical conditions 
 
X 
 
 
 
 
 
 
 
 
Previous treatment 3 
 
X 
 
 
 
 
 
 
 
 
Claudin 18.2 Detection 4 
X 
 
 
 
 
 
 
 
 
 
ECOG score 
 
X 
 
X 
 
X 
 
X 
X 
 
Vital signs 
 
X 
 
X 
 
X 
 
X 
X 
 
Physical examination 
 
X 
 
X 
 
X 
 
X 
X 
 
Blood oxygen saturation 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Height/body surface area 
 
X 
 
 
 
 
 
 
 
 
weight 
 
X 
 
X 
 
X 
 
X 
X 
 
Complete blood count 
 
X 
X 
X 
X 
X 
X 
X 
X 
 

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Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 86 NUMPAGES  
 
Study period/visit 
Molecular pre-
screening phase 
Screening 
Period 1 
Single 
sampling 
2 
Treatment period 
Exit Treatment 
Visit 10 
Survival follow-
up 
C1 (21 days) 
C2 (21 days) 
Subsequent 
treatment 
cycle 12 
Visit time 
~D42 
D-42~D-1 
D0 
D1 
D 8 
D1 
D 8 
D1 
 
Every 12 weeks 
Time Window 
 
 
± 3 days 
 
± 3 days 
 
± 3 days 
 
Within 30 days 
after the last dose 
±14d 
Urinalysis 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Stool routine and occult 
blood test 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Blood biochemistry 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Coagulation function 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Amylase and lipase 
 
X 
 
X 
 
X 
 
X 
X 
 
C-reactive protein 
 
X 
 
X 
 
X 
 
X 
X 
 
Peripheral blood ferritin 
 
X 
 
 
 
 
 
 
 
 
Pregnancy test 5 
 
X 
According to clinical signs, if women of childbearing age who are fertile 
experience amenorrhea, morning sickness, abdominal pain, vaginal 
bleeding, or other symptoms suspected of pregnancy, they should be 
reviewed promptly. 
 
 
fasting blood sugar 
 
X 
 
Diabetic patients should undergo timely review according to clinical needs 
 
Infectious 
disease 
examination 
 
X 
 
 
 
 
 
 
 
 
Gastroscopy 6 
 
X 
 
 
 
 
 
 
 
 
12-lead 
electrocardiogram 
 
X 
 
X 
 
X 
 
X 
X 
 
echocardiography 
 
X 
 
Based on clinical signs, if symptoms or signs suggestive of 
heart failure occur, a follow-up examination should be 
conducted promptly. 
 
 
Tumor markers 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
X 
 
Imaging examination7 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
X 
 
Tumor Assessment8 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
X 
 

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Version number / version date: V2.1 / September 27, 2025 
Page 81 87 NUMPAGES  
 
Study period/visit 
Molecular pre-
screening phase 
Screening 
Period 1 
Single 
sampling 
2 
Treatment period 
Exit Treatment 
Visit 10 
Survival follow-
up 
C1 (21 days) 
C2 (21 days) 
Subsequent 
treatment 
cycle 12 
Visit time 
~D42 
D-42~D-1 
D0 
D1 
D 8 
D1 
D 8 
D1 
 
Every 12 weeks 
Time Window 
 
 
± 3 days 
 
± 3 days 
 
± 3 days 
 
Within 30 days 
after the last dose 
±14d 
Random 2 
 
 
X 
 
 
 
 
 
 
 
Leukocyte apheresis 
 
 
X 
 
 
 
 
 
 
 
Control group treatment 9 
 
 
 
X 
 
X 
 
X 
 
 
Concomitant medication 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Quality of Life Scale 11 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
 
 
Recording adverse events 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Living conditions 
 
 
 
 
 
 
 
 
 
X 
Other 
anti-tumor 
treatments 
 
 
 
 
 
 
 
 
 
X 
 
Note: 
1. Subjects must complete all required visits according to the visit schedule during the screening period. The primary and subsequent follow-up visits are calculated based 
on the randomization date (D0). If necessary, screening tests can be performed simultaneously with molecular screening tests . In this case, patients must sign both the 
molecular pre-screening informed consent form and the primary informed consent form. 
2. The date of randomization is designated as D0. Subjects randomized into the trial group will undergo apheresis on the day of randomization or the day following, after 
the investigators have initially assessed their eligibility. Routine blood test results, if available within 7 days prior to leukocyte apheresis, can be used to assess the safety 
and standard of apheresis. If the last routine blood test has been performed more than 7 days prior to leukocyte apheresis, or if the investigators determine that the subject's 
hematological parameters may have changed, a routine blood test should be performed within 7 days prior to apheresis . 
3. All medications (including nutritional supplements such as vitamins, therapeutic solvents or solvents) and non-drug treatments used within 30 days before the first 
signing of the principal informed consent form should be recorded. 
4 . Potentially eligible subjects will sign the molecular prescreening informed consent form and undergo CLDN18.2 target screening and related molecular biological 
characterization tests. Subjects are required to provide a tumor tissue specimen (paraffin block or section). If a tumor tissue specimen is unavailable, a biopsy will be 
performed during the molecular prescreening period for central laboratory screening of CLDN18.2 expression. Sample requirements include: formalin-fixed, paraffin-
embedded tumor tissue block (paraffin blocks within 2 years are acceptable), fresh biopsy tissue, or at least 6-10 freshly cut, 4-5 μm thick, unstained tissue sections. 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 88 NUMPAGES  
 
5. Blood pregnancy tests are only applicable to female subjects of childbearing age who are fertile. Urine or blood pregnancy tests may be performed during the study if 
deemed necessary by the investigator. Testing should be performed during the screening period. Women of childbearing age include premenopausal women and women 
within 24 months of menopause. Infertile women are defined as: 1. Postmenopausal women (menopause for at least one year); 2. Women who have undergone bilateral 
oophorectomy or hysterectomy. 
6. Gastroscopy is required during the screening period . For subjects who have undergone total gastrectomy, the researcher will determine whether gastroscopy is necessary. 
7. ① Imaging examinations include enhanced MRI of the head, enhanced CT or MRI of the chest, abdomen, and pelvis , and bone scan results (if bone metastases or 
signs of bone metastases are present). Subjects with contrast agent allergies may undergo conventional CT /MRI examinations . Enhanced MRI of the head is mandatory 
during the screening period and optional during the follow-up period at the investigator's discretion if no abnormalities are present . ② Imaging examinations required 
for enrollment assessments may be performed within 28 days prior to signing the informed consent form. Additionally, an imaging assessment must be performed within 
14 days prior to randomization as the baseline for this study . ③ During the primary and subsequent follow-up periods, enhanced CT or MRI imaging examinations will 
be performed according to the trial schedule. Based on the subject's clinical signs, if a subject is suspected of achieving complete remission or disease progression, the 
investigator may determine whether to increase the frequency of testing based on actual circumstances . ④ The examination methods for the same subject and the same 
site during the baseline and follow-up periods should remain consistent . 
8. Tumor Assessment: Imaging assessment within 14 days before randomization served as the baseline of this study. Starting from apheresis after randomization, the first 
tumor assessment was performed at 8 weeks ± 7 days, and tumor assessments were performed every 6 weeks ± 7 days thereafter until disease progression determined 
by the investigator and confirmed by BIRC, or the patient started new anti-tumor treatment, died, was lost to follow-up, or withdrew from the study, whichever occurred 
first. 
9. Docetaxel alone 75-100 mg/m 2 , intravenous drip, on day 1, repeated every 21 days. 
10. If a subject withdraws from treatment for any reason, the withdrawal visit will be completed within 30 days of the last dose and before starting any new anti-cancer 
therapy. Subjects who have completed the required assessment within 7 days prior to withdrawal do not need to undergo a repeat examination. Imaging examinations 
that have already been performed within 4 weeks and do not require reconfirmation do not need to be repeated (if appropriate safety follow-up examinations have already 
been performed during this period, repeat examinations are not required). 
11. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OG25 questionnaires: Assessments were performed during the screening 
period, 8 weeks ± 7 days after randomization, and then every 6 weeks ± 7 days until the patient started new anti-tumor treatment, died, was lost to follow-up, or 
withdrew from the study, whichever occurred first. 
12. During subsequent treatment cycles, physical examination, vital signs, ECOG score, blood routine test, and blood biochemistry test should be performed within 3 
days before the first medication of each cycle. Coagulation function, C-reactive protein, urine routine test, stool routine test and occult blood test, blood oxygen saturation, 
and electrocardiogram test should be performed within 3 days before the first medication of every 2 treatment cycles (i.e., the 3rd, 5th, 7th, and 9th cycles, and so on). 
 
 

Protocol number: IMC002-RT02-RCT 
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Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 89 NUMPAGES  
 
surface 6. Control group (irinotecan alone) 
Study period/visit 
Molecular pre-
screening phase 
Screening 
Period 1 
Single 
sampling 
2 
Treatment period 
Exit 
Treatment 
Visit 10 
Survival follow-
up 
C1 (14 days) 
C2 (14 days) 
Subsequent 
treatment 
cycle 12 
Visit time 
~D42 
D-42~D-1 
D0 
D1 
D 8 
D1 
D 8 
D1 
 
Every 12 weeks 
Time Window 
 
 
± 3 days 
 
± 3 days 
 
± 3 days 
 
Within 30 days 
after the last 
dose 
±14d 
Sign the molecular pre-
screening 
informed 
consent form 
X 
 
 
 
 
 
 
 
 
 
Sign 
the 
informed 
consent form 
 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
Criteria 
 
X 
 
 
 
 
 
 
 
 
Demographic data 
X 
X 
 
 
 
 
 
 
 
 
Tumor 
diagnosis 
and 
treatment history 
 
X 
 
 
 
 
 
 
 
 
Tumor classification and 
staging during screening 
 
X 
 
 
 
 
 
 
 
 
History 
of 
non-study 
illnesses/allergies/current 
medical conditions 
 
X 
 
 
 
 
 
 
 
 
Previous treatment 3 
 
X 
 
 
 
 
 
 
 
 
Claudin 18.2 Detection 4 
X 
 
 
 
 
 
 
 
 
 
ECOG score 
 
X 
 
X 
 
X 
 
X 
X 
 
Vital signs 
 
X 
 
X 
 
X 
 
X 
X 
 
Physical examination 
 
X 
 
X 
 
X 
 
X 
X 
 
Blood oxygen saturation 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Height/body surface area 
 
X 
 
 
 
 
 
 
 
 
weight 
 
X 
 
X 
 
X 
 
X 
X 
 

Protocol number: IMC002-RT02-RCT 
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Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 90 NUMPAGES  
 
Study period/visit 
Molecular pre-
screening phase 
Screening 
Period 1 
Single 
sampling 
2 
Treatment period 
Exit 
Treatment 
Visit 10 
Survival follow-
up 
C1 (14 days) 
C2 (14 days) 
Subsequent 
treatment 
cycle 12 
Visit time 
~D42 
D-42~D-1 
D0 
D1 
D 8 
D1 
D 8 
D1 
 
Every 12 weeks 
Time Window 
 
 
± 3 days 
 
± 3 days 
 
± 3 days 
 
Within 30 days 
after the last 
dose 
±14d 
Complete blood count 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Urinalysis 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Stool routine and occult 
blood test 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Blood biochemistry 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Coagulation function 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Amylase and lipase 
 
X 
 
X 
 
X 
 
X 
X 
 
C-reactive protein 
 
X 
 
X 
 
X 
 
X 
X 
 
Peripheral blood ferritin 
 
X 
 
 
 
 
 
 
 
 
Pregnancy test 5 
 
X 
According to clinical signs, if women of childbearing age who are fertile 
experience amenorrhea, morning sickness, abdominal pain, vaginal 
bleeding, or other symptoms suspected of pregnancy, they should be 
reviewed promptly. 
 
 
fasting blood sugar 
 
X 
 
Diabetic patients should undergo timely review according to clinical needs 
 
Infectious 
disease 
examination 
 
X 
 
 
 
 
 
 
 
 
Gastroscopy 6 
 
X 
 
 
 
 
 
 
 
 
12-lead 
electrocardiogram 
 
X 
 
X 
 
X 
 
X 
X 
 
echocardiography 
 
X 
 
Based on clinical signs, if symptoms or signs suggestive of heart 
failure occur, a follow-up examination should be conducted 
promptly. 
 
 
Tumor markers 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
X 
 
Imaging examination7 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
X 
 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 91 NUMPAGES  
 
Study period/visit 
Molecular pre-
screening phase 
Screening 
Period 1 
Single 
sampling 
2 
Treatment period 
Exit 
Treatment 
Visit 10 
Survival follow-
up 
C1 (14 days) 
C2 (14 days) 
Subsequent 
treatment 
cycle 12 
Visit time 
~D42 
D-42~D-1 
D0 
D1 
D 8 
D1 
D 8 
D1 
 
Every 12 weeks 
Time Window 
 
 
± 3 days 
 
± 3 days 
 
± 3 days 
 
Within 30 days 
after the last 
dose 
±14d 
Tumor Assessment8 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
 
 
Random 2 
 
 
X 
 
 
 
 
 
 
 
Leukocyte apheresis 
 
 
X 
 
 
 
 
 
 
 
Control group treatment 9 
 
 
 
X 
 
X 
 
X 
 
 
Concomitant medication 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
EORTC Quality of Life 
Scale 11 
 
X 
 
First time: 8 ± 7 days, then every 6 weeks ± 7 days 
X 
 
Recording adverse events 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Living conditions 
 
 
 
 
 
 
 
 
 
X 
Other 
anti-tumor 
treatments 
 
 
 
 
 
 
 
 
 
X 
Note: 
1. Subjects must complete all required visits according to the visit schedule during the screening period. The primary and subsequent follow-up visits are calculated based 
on the randomization date (D0). If necessary, screening tests can be performed simultaneously with molecular screening tests . In this case, patients must sign both the 
molecular pre-screening informed consent form and the primary informed consent form. 
2. The date of randomization is designated as D0. Subjects randomized into the trial group will undergo apheresis on the day of randomization or the day following, after 
the investigators have initially assessed their eligibility. Routine blood test results, if available within 7 days prior to leukocyte apheresis, can be used to assess the safety 
and standard of apheresis. If the last routine blood test has been performed more than 7 days prior to leukocyte apheresis, or if the investigators determine that the subject's 
hematological parameters may have changed, a routine blood test should be performed within 7 days prior to apheresis . 
3. All medications (including nutritional supplements such as vitamins, therapeutic solvents or solvents) and non-drug treatments used within 30 days before the first 
signing of the principal informed consent form should be recorded. 
4 . Potentially eligible subjects will sign the molecular prescreening informed consent form and undergo CLDN18.2 target screening and related molecular biological 
characterization tests. Subjects are required to provide a tumor tissue specimen (paraffin block or section). If a tumor tissue specimen is unavailable, a biopsy will be 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 92 NUMPAGES  
 
performed during the molecular prescreening period for central laboratory screening of CLDN18.2 expression. Sample requirements include: formalin-fixed, paraffin-
embedded tumor tissue block (paraffin blocks within 2 years are acceptable), fresh biopsy tissue, or at least 6-10 freshly cut, 4-5 μm thick, unstained tissue sections. 
5. Blood pregnancy tests are only applicable to female subjects of childbearing age who are fertile. Urine or blood pregnancy tests may be performed during the study if 
deemed necessary by the investigator. Testing should be performed during the screening period. Women of childbearing age include premenopausal women and women 
within 24 months of menopause. Infertile women are defined as: 1. Postmenopausal women (menopause for at least one year); 2. Women who have undergone bilateral 
oophorectomy or hysterectomy. 
6. Gastroscopy is required during the screening period . For subjects who have undergone total gastrectomy, the researcher will determine whether gastroscopy is necessary. 
7. ① Imaging examinations include enhanced MRI of the head, enhanced CT or MRI of the chest, abdomen, and pelvis , and bone scan results (if bone metastases or 
signs of bone metastases are present). Subjects with contrast agent allergies may undergo conventional CT /MRI examinations . Enhanced MRI of the head is mandatory 
during the screening period and optional during the follow-up period at the investigator's discretion if no abnormalities are present . ② Imaging examinations required 
for enrollment assessments may be performed within 28 days prior to signing the informed consent form. Additionally, an imaging assessment must be performed within 
14 days prior to randomization as the baseline for this study . ③ During the primary and subsequent follow-up periods, enhanced CT or MRI imaging examinations will 
be performed according to the trial schedule . Based on the subject's clinical signs, if a subject is suspected of achieving complete remission or disease progression, the 
investigator may determine whether to increase the frequency of testing based on actual circumstances . ④ The examination methods for the same subject and the same 
site during the baseline and follow-up periods should remain consistent . 
 
8. Tumor Assessment: Imaging assessment within 14 days before randomization served as the baseline of this study. Starting from apheresis after randomization, the first 
tumor assessment was performed at 8 weeks ± 7 days, and tumor assessments were performed every 6 weeks ± 7 days thereafter until disease progression determined 
by the investigator and confirmed by BIRC, or the patient started new anti-tumor treatment, died, was lost to follow-up, or withdrew from the study, whichever occurred 
first. 
9 . Irinotecan monotherapy: 150-180 mg/m 2 , intravenous drip, on day 1, repeated every 14 days. 
10. If a subject withdraws from treatment for any reason, the withdrawal visit will be completed within 30 days after the last dose and before starting any new anti-cancer 
treatment. Subjects who have completed the required assessment within 7 days before withdrawal do not need to undergo a repeat examination. Imaging examinations 
that have been performed within 4 weeks and do not require reconfirmation do not need to be repeated (if a corresponding safety follow-up examination has been 
performed during this period, a repeat examination is not required). 
11. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OG25 questionnaires: Assessments were performed at screening, 8 weeks 
± 7 days after randomization, and every 6 weeks ± 7 days thereafter until the patient started new anti-tumor treatment, died, was lost to follow-up, or withdrew from 
the study, whichever occurred first. 
12. During subsequent treatment cycles, physical examination, vital signs, ECOG score, blood routine test, and blood biochemistry test should be performed within 3 
days before the first medication of each cycle. Coagulation function, C-reactive protein, urine routine test, stool routine test and occult blood test, blood oxygen saturation, 
and electrocardiogram test should be performed within 3 days before the first medication of every 2 treatment cycles (i.e., the 3rd, 5th, 7th, and 9th cycles, and so on). 

Protocol number: IMC002-RT02-RCT 
Immunofoco 
Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 93 NUMPAGES  
 
 
 

Protocol number: IMC002-RT02-RCT 
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Clinical research protocol 
 
Version number / version date: V2.1 / September 27, 2025 
Page 81 94 NUMPAGES  
 
Table 7 Flowchart of the control group receiving subsequent IMC002 treatment 
Study period/visit 
Drainage 
pretreatment 
 
the infusion day and within 28 days after 
infusion 
Main follow-up period 
Follo
w-up 
Exit 
Treatme
nt Visit 8 
Surv
ival 
visit 
Pre-drainage 
assessment 
(baseline) 1 
Clearin
g the 
bowels 
Pre-
infusi
on 
assess
ment 
2 
Infusio
n 
 
Follow-up within 28 days after infusion 
Visit time 
Before 
shower 
7 days 
- D 5~- 
D3 
-D1 
D0 
D1 
D 3 
D 7 
D9 
D 14 D 21 
D 28 W1 0 W 16 W 22 W 28 W3 4 W4 0 W 46 W 52 
~ 7 
 
Ever
y 12 
week
s 
Time Window 
 
 
 
 
 
±1d 
 
 
±2d 
±2d 
±2d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±14d 
Verify inclusion and 
exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECOG score 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Physical examination 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Blood 
oxygen 
saturation 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Height/body 
surface 
area 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
weight 
X 
 
 
 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Complete blood count 
X 
 
X 
X 11 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Urinalysis 
X 
 
 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Stool routine and occult 
blood test 
X 
 
 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Blood biochemistry 
X 
 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Coagulation function 
X 
 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Amylase and lipase 
X 
 
 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
C-reactive protein 
X 
 
 
 
X 
X 
X 
 
X 
X 
X 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 
14 
( X ) 14 
 
X 
 
Peripheral blood ferritin 
X 
 
 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Tumor markers 
X 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Pregnancy test 3 
 
According to clinical signs, if women of childbearing age who are fertile experience amenorrhea, morning sickness, abdominal pain, vaginal 
bleeding, or other symptoms suspected of pregnancy, they should be reviewed promptly. 
 
 
fasting blood sugar 
X 
 
Diabetic patients should undergo timely review according to clinical needs 
 

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Study period/visit 
Drainage 
pretreatment 
 
the infusion day and within 28 days after 
infusion 
Main follow-up period 
Follo
w-up 
Exit 
Treatme
nt Visit 8 
Surv
ival 
visit 
Pre-drainage 
assessment 
(baseline) 1 
Clearin
g the 
bowels 
Pre-
infusi
on 
assess
ment 
2 
Infusio
n 
 
Follow-up within 28 days after infusion 
Visit time 
Before 
shower 
7 days 
- D 5~- 
D3 
-D1 
D0 
D1 
D 3 
D 7 
D9 
D 14 D 21 
D 28 W1 0 W 16 W 22 W 28 W3 4 W4 0 W 46 W 52 
~ 7 
 
Ever
y 12 
week
s 
Time Window 
 
 
 
 
 
±1d 
 
 
±2d 
±2d 
±2d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±14d 
Infectious 
disease 
examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead 
electrocardiogram 
X 
 
X 
X 6 
X 6 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
echocardiography 
 
Based on clinical signs, if symptoms or signs suggestive of heart failure occur, a follow-up examination should be conducted promptly. 
 
 
Imaging examination4 
X 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Tumor Assessment 5 
X 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Lymph 
effusion 
pretreatment 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IMC002 Feedback 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CAR copy number 9 
X 
 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
 
 
 
X 
X 
 
CAR-T cells 
Subgroup/Phenotype 9 
X 
 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
 
 
 
X 
X 
 
Cytokine 9 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
 
 
 
X 
X 
 
Immunogenicity testing10 
 
 
X 
 
 
 
 
 
 
 
X 
 
X 
 
X 
 
 
 
X 
X 
 
RCL test 11 
 
 
X 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
 
 
X 
X 
 
Lentiviral 
genome 
insertion site 12 
 
 
X 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
 
 
X 
X 
 
Exploratory 
indicator 
testing 
 
 
Based on the availability of actual clinical samples, the researcher will decide whether to conduct exploratory research with 
informed consent. 
 
 
EORTC Quality of Life 
Scale 13 
X 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
Concomitant 
medication 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 

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Study period/visit 
Drainage 
pretreatment 
 
the infusion day and within 28 days after 
infusion 
Main follow-up period 
Follo
w-up 
Exit 
Treatme
nt Visit 8 
Surv
ival 
visit 
Pre-drainage 
assessment 
(baseline) 1 
Clearin
g the 
bowels 
Pre-
infusi
on 
assess
ment 
2 
Infusio
n 
 
Follow-up within 28 days after infusion 
Visit time 
Before 
shower 
7 days 
- D 5~- 
D3 
-D1 
D0 
D1 
D 3 
D 7 
D9 
D 14 D 21 
D 28 W1 0 W 16 W 22 W 28 W3 4 W4 0 W 46 W 52 
~ 7 
 
Ever
y 12 
week
s 
Time Window 
 
 
 
 
 
±1d 
 
 
±2d 
±2d 
±2d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±7d 
±14d 
Recording 
adverse 
events 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Living conditions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Other 
anti-tumor 
treatments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Note: 
1. Within 7 days before lymphoproliferative pretreatment, the investigator will conduct another examination based on the subject's disease status, including but not limited 
to routine blood and urine tests, blood biochemistry, pancreatic function, coagulation function, and electrocardiogram (ECG) . The inclusion criteria will be verified 
before lymphoproliferative pretreatment . Subjects deemed qualified by the investigator will undergo lymphoproliferative pretreatment. The visit time in this visit form 
is calculated based on the day of IMC002 infusion as day 0. Any extension of the pre-infusion time window due to factors such as CAR-T cell preparation or bridging 
therapy will not be recorded as a protocol deviation. 
2. Before cell infusion, the investigator must re-evaluate the subject. Only subjects who meet the cell infusion criteria can undergo cell infusion. If the subject does not 
meet the cell infusion criteria, the infusion can be delayed for no more than 7 days . If the delay exceeds 7 days , the investigator will evaluate whether the subject should 
repeat the baseline examination and lymphadenopathy pretreatment process. At least 14 days of hospitalization and observation should be completed from the date of 
cell infusion. The 15-28 days of hospitalization and observation should be based on local diagnosis and treatment standards. If the hospitalization period is extended due 
to diagnosis and treatment standards, it will not be recorded as an SAE. 
3. Blood pregnancy tests are only applicable to female subjects of childbearing age who are fertile. Urine/blood pregnancy tests may be performed during the study if 
deemed necessary by the investigator. Testing should be performed during the screening period. Women of childbearing age include premenopausal women and women 
within 24 months of menopause. Infertile women are defined as: 1. Postmenopausal women (amenorrhea for at least one year); 2. Women who have undergone bilateral 
oophorectomy or hysterectomy. 
4. ① Imaging examinations include enhanced MRI of the head, enhanced CT or MRI of the chest, abdomen, and pelvis , and bone scan results (if bone metastases or 
signs of bone metastases are present). Subjects with contrast agent allergies may undergo conventional CT /MRI examinations . Enhanced MRI of the head is mandatory 

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during the screening period and optional during the follow-up period at the investigator's discretion if no abnormalities are present . ② Imaging examinations required 
for enrollment assessments may be performed within 28 days prior to signing the informed consent form. Additionally, an imaging assessment must be performed within 
14 days prior to randomization as the baseline for this study . ③ During the primary and subsequent follow-up periods, enhanced CT or MRI imaging examinations will 
be performed according to the trial schedule. Based on the subject's clinical signs, if a subject is suspected of achieving complete remission or disease progression, the 
investigator may determine whether to increase the frequency of testing based on actual circumstances . ④ The examination methods for the same subject and the same 
site during the baseline and follow-up periods should remain consistent . 
5. Tumor Assessment: Imaging assessment before lympholysis was used as the baseline; the infusion day was designated as D0, and the first tumor assessment was 
performed on the 4th week ± 2 days after infusion. Tumor assessment was performed every 6 weeks ± 7 days thereafter until disease progression determined by the 
investigator occurred, or the patient started new anti-tumor treatment, died, was lost to follow-up, or withdrew from the study, whichever occurred first. 
6. If the patient has ECG monitoring after infusion, ECG examinations on the infusion day and 1 day after infusion may not be performed . 
7. After W52 (inclusive), return to the research center for relevant examinations every 6 weeks, with a visit window period of ±7 days, until PD, death , or withdrawal 
from the trial (whichever occurs first). 
8. If a subject withdraws from treatment for any reason, the withdrawal visit will be completed within 7 days of withdrawal and before starting any new anti-cancer 
treatment. If the subject has completed the required assessment within 7 days before withdrawal, no repeat examination is required. Imaging examinations that have been 
performed within 4 weeks and do not require reconfirmation do not need to be repeated (if corresponding safety follow-up examinations have been performed during this 
period, repeat examinations are not required). 
9. Blood samples for CAR copy number, CAR-T cell subsets/phenotypes, and cytokines should be collected before lymphoblastic effusion (within 7 days), before IMC002 
infusion, 30 minutes ± 5 minutes after cell infusion, 3 days, 7 days, 9 days, 14 days, 28 days, W10, W16 (± 7 days), W28 (± 7 days), W52 (± 7 days), W94 (± 7 
days), and at the exit visit. Blood samples should be collected every 6 months for 2 years after cell infusion. Blood samples should be collected until disease progression, 
2 consecutive undetectable CAR copy numbers after peak detection, death, or patient withdrawal from the study due to other reasons, whichever occurs first. 
10. Immunogenicity testing will be performed at the pre-lympholysis assessment (within 7 days), day 28 after cell infusion, week 16, week 28, week 52, and week 94 
after cell infusion, as well as at the exit visit. If the CAR copy number is still detectable in peripheral blood 2 years after cell infusion, then testing will be performed 
every 6 months thereafter. If the CAR copy number is undetectable for two consecutive times after week 16 (including testing before week 14), or in the event of death, 
withdrawal of informed consent, 15 years after cell infusion, or trial termination (whichever occurs first), no further testing will be performed. 
11. RCL testing should be performed before IMC002 infusion, at Weeks 16, 28, 52, and 94 after cell infusion, and at the withdrawal visit. Blood samples should be 
collected annually two years after cell infusion until the subject is lost to follow-up, dies, withdraws informed consent, 15 years after cell infusion, or terminates the trial 
(whichever occurs first). If the RCL test is negative within 28 weeks after IMC002 infusion and there are no clinical signs of abnormal lentiviral expansion, blood samples 
collected after 28 weeks can be retained and not tested. 
12. The time points for lentiviral genome insertion site detection are before IMC002 infusion , 16 weeks , 28 weeks, 52 weeks , and 94 weeks after cell infusion , and at 
the exit visit . Data will be collected once a year after 2 years of cell infusion until the subject is lost to follow-up, dies, withdraws informed consent, 15 years after cell 
infusion, or the trial is terminated (whichever occurs first). 

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13. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OG25 questionnaires: Assessments were conducted before lymphoblastic 
leukemia, on day 28 ± 2 days after infusion, and every 6 weeks ± 7 days thereafter until the patient started new anti-cancer treatment, died, was lost to follow-up, or 
withdrew from the study, whichever occurred first. 
14. Researchers may decide whether to conduct this test based on actual circumstances.

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6.2 Visit Arrangements 
6.2.1 Molecular Prescreening Period (~ D- 42)  
Potentially eligible subjects will sign the molecular prescreening informed consent form and 
undergo CLDN18.2 target screening and related molecular biological profiles (such as the tumor 
immune microenvironment and tumor mutational burden (TMB )) . Subjects are required to 
provide a tumor tissue specimen (paraffin block or section). If a tumor tissue specimen is 
unavailable, a biopsy will be performed during the molecular prescreening period for central 
laboratory screening of CLDN18.2 expression. Sample requirements include: formalin-fixed, 
paraffin-embedded tumor tissue block (paraffin blocks within 2 years are acceptable), fresh biopsy 
tissue, or at least 6–10 freshly cut, 4–5 μm thick, unstained tissue sections. If subjects have 
received other CLDN18.2-targeted therapies, they must provide a post-treatment tumor tissue 
specimen before enrollment to reassess CLDN18.2 expression levels. 
using 
a 
companion 
diagnostic 
reagent, 
Claudin 
18.2 
antibody 
reagent 
(immunohistochemistry) , which the sponsor will simultaneously use for companion diagnostic 
reagent (CDx) development. 
If the central laboratory test results do not meet the protocol-required CLDN 18.2 expression 
level, the patient will be considered a pre-screening failure and will not be considered for 
subsequent screening. For subjects who fail pre-screening and do not sign the primary informed 
consent form, the EDC must record the subject's demographic information and the time the pre-
screening informed consent form was signed. 
6.2.2 Screening period (D- 42 to D-1) 
advanced gastric cancer who meet the protocol requirements for CLDN 18.2 expression as 
determined by central laboratory testing may enter the screening phase after signing the Master 
Informed Consent Form. All patients participating in the screening phase must sign the Master 
Informed Consent Form . If necessary, screening can be performed concurrently with molecular 
screening . In this case, patient screening must begin after signing the Molecular Pre-Screening 
Informed Consent Form and the Master Informed Consent Form. After signing the Master 
Informed Consent Form, patients will undergo screening phase examinations and assessments, 
including: 
Screening period: 
1) Signed Master Informed Consent ( obtained before any study-related tests or procedures 
other than molecular screening tests ) 
2) Demographic data collection 
3) Tumor diagnosis and treatment history, tumor stage and pathology (including previous 
and current anti-tumor treatments) 
4) Non-tumor medical history, concomitant diseases, and previous treatment history 

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5) History of non-study illnesses/allergies/current medical conditions 
6) Previous treatment for non-study disease 
7) Claudin 18.2 test results (Central Laboratory) 
8) ECOG score 
9) Vital signs 
10) Physical examination 
11) Blood oxygen saturation (pulse oxygen) 
12) Height/ body surface area (Body surface area is calculated based on the patient's height 
and weight only during the lymph node clearance period) 
13) weight 
14) Complete blood count 
15) Urinalysis 
16) Stool routine and occult blood test 
17) Blood biochemistry 
18) Coagulation tests 
19) Blood amylase and lipase 
20) C-reactive protein 
21) Peripheral blood ferritin 
22) Blood pregnancy test (needed for women of childbearing age, defined as those who have 
not yet menopausal or have been menopausal for less than 2 years) 
23) fasting blood sugar 
24) Infectious disease testing (central laboratory testing) 
25) Gastroscopy (gastroscopy is required during the screening period, and the researcher will 
determine whether gastroscopy is necessary for subjects who have undergone total 
gastrectomy) 
26) 12-lead electrocardiogram 
27) Echocardiography (including LVEF) 
28) Tumor markers 
29) Imaging tests and tumor assessments (imaging tests required for enrollment assessment 
can be performed within 28 days before signing the informed consent form. At the same 
time, imaging assessments must be performed within 14 days before randomization as 
the baseline of this study) 

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30) European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, 
QLQ-OG25 questionnaires 
31) Combination drug/non-drug treatment 
32) Adverse event records 
For detailed examination items, please refer to Table 3, the study flow chart of the 
experimental group , for screening period examinations . Researchers can add relevant tests 
based on the actual situation of the patients. 
After completing all the aforementioned screening tests , the inclusion/exclusion criteria for 
the screening period will be verified. Subjects meeting all inclusion criteria and none of the 
exclusion criteria will be enrolled and undergo leukocyte apheresis . After apheresis, the blood is 
transported to the cell production site at 2-8°C. For review and research purposes by the National 
Medical Products Administration (NMPA), the initial PBMCs are also collected and refrigerated. 
The cell product is expected to be ready for research use approximately 2-3 weeks later. 
6.2.3 Randomization (D0) 
Subjects who meet the inclusion criteria will be randomly assigned to the experimental group 
and the control group in a ratio of 2:1. 
6.2.4 Study Treatment Period Visits 
6.2.4.1 Trial Group Visit Arrangements 
6.2.4.1.1 Study Intervention (Before Lymph Circulation Treatment) 
Subjects randomized into the trial group will undergo single collection on the day of 
randomization or within 3 days after the researcher's preliminary assessment that they meet the 
requirements. 
Before apheresis to lymphoproliferative pretreatment, the researcher will judge the subject's 
condition and, based on the subject's clinical benefits and risks, may consider administering 
bridging therapy. The purpose of bridging therapy is to stabilize the subject's current disease status 
or reduce the subject's current tumor burden. For bridging therapies other than the recommended 
regimen, the researcher must discuss and confirm with the sponsor's medical department. Bridging 
therapy must be completed 7 days before lymphoproliferative pretreatment, or at least 5 half-lives 
of the bridging drug before lymphoproliferative pretreatment as a washout period (whichever is 
longer). 
7 days before the lymph node clearing pretreatment , the researcher will conduct relevant 
examinations required to determine the condition of the subject based on the subject's specific 
condition, including : 
Pre-drainage assessment: 
1)  ECOG score 

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2)  Vital signs 
3)  Blood oxygen saturation (pulse oxygen) 
4)  Height/body surface area (body surface area is calculated based on the patient's height and 
weight only during the lymph node clearance period) 
5)  Weight 
6)  Complete blood test 
7)  Urinalysis 
8)  Routine stool examination and occult blood test 
9)  Blood biochemistry 
10)  
Coagulation function test 
11)  
Blood amylase and lipase 
12)  
C -reactive protein 
13)  
Peripheral blood ferritin 
14) Collect blood samples for CAR copy number, CAR-T cell subsets/phenotypes, and 
cytokine testing 
15)  
12 -lead electrocardiogram 
16)  
Combined drug/non-drug treatment 
17)  
Adverse event records 
Detailed examination items are listed in Table 3 , the study flow chart for the trial group . 
Researchers may add relevant tests based on the patient's actual situation to assess the eligibility 
of the subject before lymphoproliferative pretreatment. Subjects assessed by the researcher as 
qualified may receive the lymphoproliferative pretreatment regimen . 
6.2.4.1.2 Lymphatic drainage pretreatment (5 to 3 days after infusion) 
To ensure optimal survival and stable expansion of autologous IMC002 within the subject, 
ensuring its anti-tumor activity, a lymphoablation pretreatment protocol will be implemented after 
successful IMC002 production and prior to infusion. This pretreatment should be performed 3-5 
days prior to IMC002 infusion (the specific number of days will be determined by the investigator 
based on clinical circumstances), after the investigator assesses the patient's condition for 
suitability. CAR-T cell infusion can begin 1-2 days after the lymphoablation protocol. If IMC002 
production is confirmed to be unsuccessful, the investigator may assess the need for repeat 
apheresis or preparation based on the subject's condition. If the subject is unsuitable for apheresis, 
they may withdraw from the study and receive other anti-tumor treatment . 
6.2.4.1.3 IMC002 Infusion 

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After the completion of the lymphoproliferative pretreatment and within one day before the 
reinfusion, the investigator will conduct relevant laboratory tests based on the subject's condition, 
including but not limited to routine blood and urine tests, blood biochemistry, and coagulation 
function tests (see Table 3 for details of the study flow chart for the experimental group ) . The 
investigator will then reassess the subject's eligibility. Subjects who meet the assessment criteria 
can undergo the IMC002 reinfusion. 
The following tests need to be completed on the day of infusion: 
1) Vital signs (monitored within 1 hour before infusion/1 hour after infusion , and additional 
testing may be performed after infusion at the investigator's discretion ) 
2) 
Blood oxygen saturation (pulse oximetry) testing (monitored within 1 hour before 
infusion/1 hour after infusion , and additional testing may be performed after infusion at 
the investigator's discretion ) 
3) 
Complete blood test (can be tested after infusion unless deemed necessary by the 
researcher) 
4) 
12-lead electrocardiogram (this item can be omitted if there is an electrocardiogram 
monitor after infusion) 
For detailed examination items, please refer to the research flow chart of the experimental 
group in Table 3. Researchers can add relevant tests based on the actual situation of the patients.  
6.2.4.1.4 Follow-up period within 28 days after infusion (infusion day + 28 days) 
1) The following tests are required on day 1, day 3 (±1 day), day 7, day 9, day 14 (±2 days), 
day 21 (±2 days), and day 28 (±2 days) after cell infusion : 
2) ECOG score ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
3) Vital signs ( D1/D3/D7/D14/D21/D28 after infusion ) 
4) Physical examination ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
5) Blood oxygen saturation (pulse oxygen) test ( D1/D3/D7/D14/D21/D28 after infusion ) 
6) Body weight ( D7/D14/D21/D28 after infusion ) 
7) Complete blood test ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
8) Urinalysis ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
9) Stool routine and occult blood test ( performed on D1/D3/D7/D14/D21/D28 after 
infusion ) 
10) Blood biochemistry ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
11) Coagulation test ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
12) Amylase and lipase ( performed on Day 1/D3/D7/D14/D21/D28 after infusion ) 

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13) C-reactive protein ( measured on D1/D3/D7/D14/D21/D28 after infusion ) 
14) Peripheral blood ferritin ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
15) 12-lead electrocardiogram ( performed on D1/D7 /D14 /D28 after infusion ; D1 can be 
omitted if an ECG monitor is used after infusion) 
16) Echocardiogram (including LVEF) ( Based on clinical signs, if the subject develops 
symptoms or signs of heart failure, the examination should be repeated promptly) 
17) Tumor markers ( performed on D28 after infusion ) 
18) Collect blood samples for monitoring of cytokines, CAR copy number, and CAR-T cell 
subsets/phenotypes ( D3/D7/D9/ D14 /D28 after infusion ) until the CAR copy number 
test results are negative or below the detection limit for two consecutive times . 
19) Anti-CAR anti-drug antibody (ADA) detection ( D28 after infusion ) 
For detailed examination items, please refer to the research flow chart of the experimental 
group in Table 3. Researchers can add relevant tests based on the actual situation of the patients , 
and can also decide whether to conduct exploratory studies on characteristic detection of tumor 
immune microenvironment based on the accessibility of clinical samples and informed consent. 
6.2.4.1.5 Follow-up period ( W8 after randomization ) 
(± 7 days) after randomization (the trial group must also meet the requirement of at least 4 
weeks after infusion). If the W8 visit after randomization overlaps with a visit within 28 days after 
the first infusion, all examinations within 28 days after infusion and the W8 visit must be completed 
simultaneously (if there are repeated examination items, they do not need to be repeated). The 
following tests are required : 
1) ECOG score 
2) Vital signs 
3) Physical examination 
4) Blood oxygen saturation (pulse oxygen) detection 
5) weight 
6) Complete blood count 
7) Urinalysis 
8) Stool routine and occult blood 
9) Blood biochemistry 
10) Coagulation tests 
11) Amylase and lipase 
12) C-reactive protein 

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13) Peripheral blood ferritin 
14) 12-lead electrocardiogram 
15) Echocardiogram (including LVEF) ( Based on clinical signs, if the subject develops 
symptoms or signs of heart failure, the examination should be repeated promptly) 
16) Tumor markers 
17) Imaging and tumor assessment 
18) European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, 
QLQ-OG25 questionnaires 
19) Collect blood samples for monitoring of cytokines, CAR copy number, and CAR-T cell 
subsets/phenotypes until the CAR copy number test results are negative or below the 
detection limit for two consecutive times. 
For detailed examination items, please refer to the research flow chart of the experimental 
group in Table 3. Researchers can add relevant tests based on the actual situation of the patients , 
and can also decide whether to conduct exploratory studies on characteristic detection of tumor 
immune microenvironment based on the accessibility of clinical samples and informed consent. 
6.2.4.1.6 Main follow-up period (W14-W50) 
Subsequent follow-up visits are based on W14, W20, W26, W32, W38, W44, and W50, with 
patients returning to the research center every 6 weeks for corresponding examinations . The visit 
window period is ±7 days, and the following tests must be performed: 
1) ECOG score 
2) Vital signs 
3) Physical examination 
4) 
Blood oxygen saturation (pulse oxygen) detection 
5) weight 
6) Complete blood count 
7) Urinalysis 
8) Stool routine and occult blood 
9) Blood biochemistry 
10) Coagulation tests 
11) Amylase and lipase 
12) Peripheral blood ferritin ( researchers can decide whether to conduct this test based on 
actual conditions ) 

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13) C-reactive protein ( researchers can decide whether to conduct this test based on actual 
conditions ) 
14) 12-lead electrocardiogram 
15) Echocardiography ( based on clinical signs; if symptoms or signs of heart failure develop, 
follow up promptly ) 
16) Tumor markers (every 6 weeks, i.e. W14, W20, W26, W32, W38, W44, W50 ) 
17) Imaging examination and tumor assessment (performed every 6 weeks , i.e., W14, W20, 
W26, W32, W38, W44, and W50 ) 
18) European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, 
QLQ-OG25 questionnaires ( administered every 6 weeks, i.e., W14 , W20 , W26 , W32 , 
W38 , W44 , and W50 ) 
19) Blood samples were collected for cytokine, CAR copy number, CAR-T cell 
subset/phenotype , and ADA monitoring (W14 / W26 / W50 ) until the CAR copy number 
test results were negative or below the detection limit for two consecutive times. If the 
CAR copy number was undetectable for two consecutive times after W14, ADA testing 
was not performed at W26 and W50. RCL and lentiviral genome insertion site detection 
was performed (W14 / W26 / W50 ) . 
For detailed examination items, please refer to the research flow chart of the experimental 
group in Table 3. Researchers can add relevant tests based on the actual situation of the patients , 
and can also decide whether to conduct exploratory studies on characteristic detection of tumor 
immune microenvironment based on the accessibility of clinical samples and informed consent. 
6.2.4.1.7 Follow-up ( W 56~) 
After W56 (inclusive) , patients should return to the research center for examinations every 6 
weeks . The visit window period is ±7 days until PD , death, or withdrawal from the trial 
(whichever occurs first). The following tests must be performed: 
1) Tumor markers 
2) Imaging tests and tumor assessment 
3) Blood samples were collected for CAR copy number, CAR-T cell subset/phenotype , and 
ADA monitoring (performed on W9 8 ) until two consecutive test results were negative 
or below the detection limit; RCL and lentiviral genome insertion site detection was 
performed (W9 8 ) 
For detailed examination items, please refer to the research flow chart of the experimental 
group in Table 3. Researchers can add relevant tests based on the actual situation of the patients , 
and can also decide whether to conduct exploratory studies on characteristic detection of tumor 
immune microenvironment based on the accessibility of clinical samples and informed consent. 

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6.2.4.2 Arrangements for visits to the control group 
6.2.4.2.1 Single collection 
After the researchers make a preliminary assessment that the subjects who are randomized 
into the control group meet the requirements, they will undergo single collection before receiving 
the treatment drugs selected by the researchers. The single collection process is the same as that of 
the experimental group.  
6.2.4.2.2 The first and second treatment cycles 
On the day of the first dose, test results from the three days prior to the first dose are acceptable, 
unless the investigator deems it necessary to conduct additional tests. All tests should be completed 
within three days prior to the start of treatment cycle D1 (the second cycle). Investigators may add 
additional tests based on the patient's specific circumstances . Detailed tests are based on the 
different dosing regimens and are described in the control group study flow charts 4 , 5, and 6 .  
6.2.4.2.3 Subsequent treatment cycles 
All examinations should be completed within 3 days before the start of the subsequent 
treatment cycle D1. Researchers can add relevant tests based on the actual situation of the patient . 
Detailed examinations should refer to the control group study flow chart Table 4 Table 5 Table 6 
according to different medication regimens .  
6.2.4.2.4 The control group subsequently received IMC002 infusion 
6.2.4.2.4.1 Baseline of Control Group Received IMC002 Infusion 
was completed within 7 days before the urinary tract infection . 
If significant abnormalities are found and the patient does not meet the criteria for clearing 
stranguria, the patient cannot proceed with the clearing stranguria test. A retest result may be 
accepted. 
6.2.4.2.4.2 Pretreatment of leaching 
Same as 6.2.4.1.2 rinsing pretreatment 
6.2.4.2.4.3 IMC002 Infusion 
Same as 6.2.4.1.3 First infusion of IMC002 
6.2.4.2.4.4 Follow-up period within 28 days after infusion 
The following tests are required on day 1, day 3 (±1 day), day 7, day 9, day 14 (±2 days), day 
21 (±2 days), and day 28 (±2 days) after cell infusion: 
1) ECOG score ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
2) Vital signs ( D1/D3/D7/D14/D21/D28 after infusion ) 
3) Physical examination ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 

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4) Blood oxygen saturation (pulse oxygen) test ( D1/D3/D7/D14/D21/D28 after infusion ) 
5) Body weight ( D7/D14/D21/D28 after infusion ) 
6) Complete blood test ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
7) Urinalysis ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
8) Stool routine and occult blood test ( performed on D1/D3/D7/D14/D21/D28 after 
infusion ) 
9) Blood biochemistry ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
10) Coagulation test ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
11) Amylase and lipase ( performed on Day 1/D3/D7/D14/D21/D28 after infusion ) 
12) C-reactive protein ( measured on D1/D3/D7/D14/D21/D28 after infusion ) 
13) Peripheral blood ferritin ( performed on D1/D3/D7/D14/D21/D28 after infusion ) 
14) 12-lead electrocardiogram ( performed on D1/D7/D28 after infusion ; D1 can be omitted 
if an ECG monitor is used after infusion) 
15) Echocardiogram (including LVEF) ( Based on clinical signs, if the subject develops 
symptoms or signs of heart failure, the examination should be repeated promptly) 
16) Tumor markers ( performed on D28 after infusion ) 
17) Imaging examination and tumor assessment ( performed on day 28 after infusion ) 
18) Blood samples were collected for monitoring of cytokines, CAR copy number, and CAR-
T cell subsets/phenotypes (D3/D7/D9/D14/D28 after infusion) until the CAR copy 
number test results were negative or below the detection limit for two consecutive times. 
Table 7 for detailed examination items . Researchers can add relevant tests based on the actual 
situation of the patients , or decide whether to conduct exploratory studies on characteristics such 
as tumor immune microenvironment based on the availability of clinical samples and informed 
consent. 
6.2.4.2.4.5 Primary follow-up period 
should be conducted every 6 weeks at W10, W16, W22, W28, W34, W40, and W46 after 
infusion. The visit window is ±7 days and the following tests should be performed: 
1) Physical examination 
2) Vital signs 
3) 
Blood oxygen saturation (pulse oxygen) detection 
4) weight 
5) ECOG score 

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6) Complete blood count 
7) Urinalysis 
8) Stool routine and occult blood 
9) Blood biochemistry 
10) Coagulation tests 
11) Amylase and lipase 
12) Peripheral blood ferritin 
13) C-reactive protein (optional at the investigator's discretion) 
14) 12-lead electrocardiogram 
15) Echocardiography ( during the screening period and based on clinical signs; if symptoms 
or signs of heart failure develop, follow up promptly ) 
16) Tumor markers (every 6 weeks, i.e. W10, W16, W22, W28, W34, W40, W46 ) 
17) Imaging examination and tumor assessment (performed every 6 weeks, W10, W16, W22, 
W28, W34, W40, W46 ) 
18) Blood samples were collected for cytokine, CAR copy number, CAR-T cell 
subset/phenotype, and ADA monitoring until disease progression, undetectable CAR 
copy number for two consecutive times after peak detection, death, or other reasons for 
exclusion from the study (whichever occurred first); RCL and lentiviral genome insertion 
site detection were performed. 
Table 7 for detailed examination items . Researchers can add relevant tests based on the actual 
situation of the patients , or decide whether to conduct exploratory studies on characteristics such 
as tumor immune microenvironment based on the availability of clinical samples and informed 
consent. 
6.2.4.2.4.6 Follow-up 
52 (inclusive), follow-up will be conducted every 6 weeks , with a visit window of ± 7 days , 
until PD, death, or withdrawal from the trial (whichever occurs first). Follow-up must include the 
following tests: 
1) Tumor markers 
2) Imaging tests and tumor assessment 
3) Blood samples were collected for cytokine, CAR copy number, CAR-T cell 
subset/phenotype, and ADA monitoring until disease progression, undetectable CAR 
copy number for two consecutive times after peak detection, death, or other reasons for 
exclusion from the study (whichever occurred first); RCL and lentiviral genome insertion 
site detection were performed. 

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Table 7 for detailed examination items  REF _Ref190869082 \h  \* MERGEFORMAT . 
Researchers can add relevant tests based on the actual situation of the patients , or decide whether 
to conduct exploratory studies on characteristics such as tumor immune microenvironment based 
on the availability of clinical samples and informed consent. 
6.2.5 Unplanned Visits 
All unplanned visits occurring during or after the study must be recorded in the original 
medical records and CRFs. During unplanned visits, relevant adverse reactions and their changes, 
concomitant medications and treatments, and any other information deemed necessary by the 
investigator should be recorded. 
6.2.6 Exit Treatment Visit 
Subjects will complete the exit visit within 7 days of discontinuing treatment and before 
starting any new anti-cancer therapy (see Tables 4-8 for detailed examinations). Subjects who have 
completed the required assessment within 7 days before discontinuing treatment do not need to 
undergo a repeat examination. Imaging examinations that have been performed within 4 weeks 
and do not require reconfirmation do not need to be repeated. 
6.2.7 Survival Visit 
All subjects will enter the survival follow-up period after completing safety follow-up and 
efficacy follow-up (whichever is longer) after treatment discontinuation. Survival status will be 
collected every 12 weeks ( ±14 days), regardless of the reason for treatment discontinuation (except 
withdrawal of informed consent or loss to follow-up), until the subject dies, is lost to follow-up, or 
withdraws informed consent for survival follow-up. 
If an interim assessment requires an update of survival status to meet safety or regulatory 
requirements, additional survival assessments may be performed beyond the planned 12- week 
follow-up. 
Survival information can be obtained by telephone, clinic visit or letter , and the information 
will be recorded in the original documents and related eCRF . The following data will continue to 
be collected during the survival visit : 
All subsequent anti-tumor treatments were recorded until the subject's death or the end of the 
study; 
1) Survival status was recorded until the subject's death or the end of the study. 
2) SAEs related to the trial drug included the occurrence of secondary tumors. 
For patients receiving IMC002 infusion (including those in the experimental group and those 
who crossed over to the control group and received IMC002 infusion) , ADA, RCL, and lentiviral 
genome insertion site samples will be collected annually for 2 years after cell infusion until the 
subject is lost to follow-up, dies, withdraws informed consent, 15 years after cell infusion, or trial 
termination (whichever occurs first). If the RCL test is negative within 28 weeks after 

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randomization and there are no clinical signs of abnormal lentiviral expansion, blood samples 
collected after 28 weeks can be retained and not tested . 
7. Research Evaluation 
7.1 Effectiveness Evaluation 
7.1.1 Efficacy evaluation indicators 
Efficacy evaluation indicators: 
The RECIST1.1 standard was used to evaluate efficacy. The effectiveness indicators included 
objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), 
duration of response (DOR) , time to response ( TTR ) and overall survival (OS) . 
Objective response rate ( ORR ): defined as the proportion of subjects with a confirmed 
response of CR or PR; also defined as the proportion of subjects with a best overall response (BOR) 
of complete response (CR) or partial response (PR). Tumor response status was assessed by the 
BIRC according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Confirmation 
was required by repeat assessment at least 4 weeks after the initial achievement of CR or PR 
response criteria. 
Progression-free survival ( PFS ): defined as the interval from the date of randomization to 
disease progression or death from any cause, whichever occurs first. For subjects without 
documented disease progression or death, the last censored date is used as the cutoff date. 
Disease control rate ( DCR ): the proportion of subjects confirmed to have CR, PR, or SD 
(RECIST 1.1) . 
Duration of response ( DOR ): The interval from the first assessment of CR or PR to the first 
assessment of PD or death from any cause (the percentage of subjects with DOR ≥6 months, ≥9 
months, and ≥12 months will be reported). 
Time to response ( TTR ): defined as the time from the date of randomization to the first 
evaluation of the subject as CR or PR (whichever occurs first) . 
Overall survival ( OS ) was defined as the interval from the date of randomization to the date 
of death from any cause. For subjects whose death was not recorded, those who had not died by 
the analysis cutoff date were censored at the time of last contact. 
7.1.2 Efficacy evaluation criteria 
This study will establish a BIRC and assess each subject's tumor status and treatment response 
(CR, PR, SD, or PD) using RECIST 1.1 criteria . If a PR or CR is achieved, the subject must 
undergo a confirmation evaluation no less than 4 weeks after the initial evaluation. Regular 
imaging assessments will be performed until PD is confirmed. 
Tumor efficacy assessment: 
screening assessments can be performed within 28 days prior to signing the informed consent 

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form. Imaging assessments can be performed using plain and contrast-enhanced MRI or CT, with 
the specific examination site determined by the investigator based on the patient's condition. An 
imaging assessment is required within 14 days prior to randomization as the study baseline . 
Thereafter , imaging (plain and contrast-enhanced MRI or CT) and tumor marker monitoring will 
be performed at scheduled visits as outlined in Section 6. Study Procedures and Visits until disease 
progression , death, or trial withdrawal (whichever occurs first) . 
7.2 Safety Assessment 
7.2.1 Safety evaluation indicators 
According to NCI CTCAE 5.0 ( except CRS and ICANS, according to 2019 ASTCT The 
CRC /ICANS grading standard was used to evaluate the type, incidence, and severity of adverse 
events after IMC -002 cell infusion , including abnormal clinically significant laboratory test 
results, abnormal physical examination results, and immunogenicity results after treatment. 
The relevance of adverse events to the IMC002 CAR-T treatment regimen will be assessed 
by the investigator according to the attribution assessment criteria specified in the protocol. 
7.2.2 Safety evaluation projects 
Clinically significant abnormal laboratory test values should be reported as AEs, except 
during the molecular pre-screening and screening periods. Blood samples for safety assessment 
may be repeated if necessary. Clinically significant results meet one or more of the following 
conditions: 
• Examination results and accompanying symptoms; 
• Leading to changes in study medication (such as dose changes, interruptions, or permanent 
discontinuation); 
• The test results require additional diagnostic testing or medical/surgical intervention; 
• Requires significant increase in concomitant medication or other treatment; 
• The investigators believe that this test result should be reported as an adverse event. 
An examination performed solely to review an abnormality that does not meet any of the 
above criteria is not considered an adverse event. Any abnormal test result that is determined to be 
an error does not need to be reported as an adverse event. 
7.2.2.1 ECOG activity score 
The Eastern Cooperative Oncology Group (ECOG) has developed a simplified activity status 
score, which categorizes patients' activity status into six levels, ranging from 0 to 5. For details, 
see Appendix 4 of 14.4 ECOG Performance Status Score . 
7.2.2.2 Vital signs 
Vital signs will be assessed according to the study flow chart 2 : 

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• 
Blood pressure (systolic and diastolic; mmHg) 
• 
Heart rate (beats per minute) 
• 
Body temperature (°C) 
• 
Respiratory rate (breaths per minute) 
After the subject rests in the supine position for 5 minutes, vital signs will be checked. 
Investigators will assess whether abnormal values are clinically significant. 
7.2.2.3 Blood oxygen saturation 
The non-invasive pulse oximetry is used to measure the arterial oxygen saturation at the finger 
site to characterize the cerebral oxygen saturation . 
7.2.2.4 Physical examination 
will be examined according to the scheduled visits in Section 6. Study Procedures and Visit 
Schedule : general appearance, head (ears, nose, throat, eyes), respiratory system, abdomen, 
genitourinary system, musculoskeletal system, nervous system, lymphatic system, and skin. 
7.2.2.5 Routine laboratory tests 
The indicators of routine laboratory examinations are described below, and the specific 
indicators of each center may be slightly adjusted. 
 
Routine blood tests include: white blood cell count, absolute lymphocyte count, absolute 
neutrophil count, absolute monocyte count, absolute eosinophil count, absolute basophil 
count, neutrophil percentage, lymphocyte percentage, red blood cell count, hemoglobin, 
hematocrit, mean corpuscular volume, mean corpuscular hemoglobin content, and 
platelets; 
 
Urinalysis includes: specific gravity, pH, bilirubin, urine protein, glucose, ketones, 
urobilinogen, nitrite, red blood cells and white blood cells; 
 
Routine stool and occult blood examination include: color, shape, white blood cells, red 
blood cells, and occult blood tests. 
 
Blood biochemistry tests include: Blood biochemistry needs to be tested in a fasting state, 
and the test items include: alanine aminotransferase (ALT), aspartate aminotransferase 
(AST), γ-glutamyl transpeptidase (γ-GT), total bilirubin (TBIL), direct bilirubin (D-BIL), 
indirect bilirubin, alkaline phosphatase (AKP or ALP); glucose, total protein (TP), 
albumin (ALB), globulin (G), albumin/globulin (A/G) ratio; urea, creatinine, uric acid; 
lactate dehydrogenase (LDH), creatine kinase (CK), creatine kinase isoenzyme (CK-MB), 
troponin; total cholesterol, triglycerides, high-density lipoprotein, low-density 
lipoprotein, sodium, potassium, chloride, calcium, magnesium; if the research center's 
creatine kinase (CK), creatine kinase isoenzyme (CK-MB) and other tests are not 
included in the biochemical test, they need to be tested separately. 

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 
Pancreatic function tests include: serum amylase, serum lipase; 
 
Coagulation function tests include: prothrombin time, activated partial thromboplastin 
time, thrombin time and international normalized ratio (INR), fibrinogen, fibrin 
degradation products, and DD dimer. 
7.2.2.6 Infectious disease inspection ( pathogen detection ) 
During the screening period, pathogen testing will be conducted. Indicators include HBsAg, 
HBsAb, HBeAg, HBcAb, HBeAb, HCV antibody, HIV antibody, syphilis antibody, Epstein-Barr 
virus, cytomegalovirus (CMV), human T- lymphotropic virus ( HTLV ) , and the novel 
coronavirus . Both HBsAg and hepatitis B core antibody should be negative. If any of these tests 
are positive, peripheral HBV DNA testing will be required. Enrollment will only be possible if the 
HBV DNA level is below the detection limit. HCV antibody-positive subjects should undergo 
HCV RNA testing, and only those with negative RNA levels will be eligible for enrollment. The 
results of these pathogen testing are subject to the central laboratory test results . 
7.2.2.7 C - reactive protein 
High-sensitivity C-reactive protein is the first choice. If detection is difficult, conventional C-
reactive protein can be considered. 
7.2.2.8 Electrocardiogram 
will be performed according to the study procedures described in Section 6. Study Procedures 
and Visit Arrangements . The subject should rest in the supine position for 5 minutes and then be 
examined while awake. Sleeping patients should be examined 5 minutes after being awakened and 
repositioned. All ECGs must be evaluated by a qualified physician. ECG parameters include heart 
rate, PR interval, QRS duration, QT interval, and QTc. 
7.2.2.9 Echocardiography 
Echocardiography uses the principle of ultrasonic ranging to measure the cyclical movement 
of underlying structures, including the heart wall, ventricles, and valves, by transmitting pulsed 
ultrasound waves through the chest wall and soft tissue. The images are displayed on a monitor as 
curves showing the relationship between the movement of each structure and time. Recording these 
curves with a recorder constitutes an echocardiogram. Essential test item: Left ventricular ejection 
fraction (LVEF). 
7.2.2.10 Tumor markers 
Tumor markers include AFP (alpha-fetoprotein), CEA (carcinoembryonic antigen) , CA724 , 
and other tumor marker tests that researchers believe need to be added (such as CA19-9 , CA125 , 
etc.) . 

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7.2.3 Adverse events and serious adverse events 
7.2.3.1 Definition of adverse events 
Adverse events (AEs) are defined as any adverse medical events that occur to clinical trial 
subjects after they sign informed consent, regardless of whether they are causally related to the 
study drug. AEs include but are not limited to the following: 
 
Exacerbation of existing medical conditions/diseases (before entering the clinical trial) 
(including aggravation of symptoms, signs, and abnormal examinations); 
 
Any new adverse medical condition (including symptoms, signs, and newly diagnosed 
diseases); 
 
Abnormal test results of significant clinical significance. 
Medical conditions/diseases that existed before signing the informed consent will be recorded 
as AEs only if they worsen after signing the informed consent. Any clinically significant abnormal 
laboratory or other abnormal safety assessment related to the underlying disease will not be 
recorded as an AE unless the investigator determines that the patient's condition is more severe 
than expected. Clinically significant laboratory test results during the screening period should be 
recorded as medical history and not as AEs unless the investigator believes that the abnormality is 
caused by the study procedure . Symptoms and signs related to the tumor at baseline should be 
recorded as adverse events if they worsen in severity or increase in frequency during the study. 
However, disease progression assessed by imaging methods to measure cancer lesions should not be 
reported as an adverse event unless it is more severe than expected or the investigator believes that 
tumor progression is related to study medication or study procedures. If a new primary malignant 
tumor occurs, such events are considered adverse events. 
7.2.3.2 Definition of Serious Adverse Events 
A serious adverse event (SAE) is an adverse event that meets at least one of the following 
criteria: 
 
resulting in death. 
 
an AE that may cause death if the event worsens ). 
 
Resulting in hospitalization or prolonged hospitalization, excluding the following: 
 Hospitalization or prolonged hospitalization not related to worsening of an AE is 
not an SAE in itself , for example, hospitalization for management reasons (such as 
physical examinations), hospitalization specified in the clinical trial protocol, etc.  
 Hospitalization or prolonged hospitalization due to the need for close attention or 
specific medical procedures (including but not limited to examination purposes, 
physical conditioning, apheresis, lympholysis, infusion, and intensive monitoring) 
of the subject is not considered an SAE . 

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 
Elective hospitalization not related to worsening of adverse events (e.g., elective 
surgery). 
 
Resulting in permanent or severe disability or loss of function. 
 
Cause congenital anomalies or birth defects. 
Other important medical events may not be immediately life-threatening or result in death or 
require hospitalization, but may endanger the subject or require intervention to prevent any of the 
outcomes defined above, such as intensive treatment of allergic bronchospasm in the emergency 
room or at home; cachexia or convulsions not requiring hospitalization; and ongoing drug 
dependence or abuse. 
7.2.3.3 Grading of adverse events 
Investigators should evaluate AEs according to the CTCAE 5.0 criteria ( except for CRS and 
ICANS , which should be evaluated according to the 2019 ASTCT CRC/ICANS grading criteria, 
see 15.3 Appendix 3 ASTCT CRS grading and ICANS grading for details ) and assess the severity 
of AEs. Severity grading of CTCAE 5.0 version: 
Grade 1 : Mild; asymptomatic or mildly symptomatic; clinical or diagnostic findings only; no 
treatment required 
Grade 2 : Severe; minor, local, or noninvasive treatment indications required; age-appropriate 
instrumental activities of daily living (ADLs) limited (instrumental ADLs include cooking, buying 
groceries or clothes, using the telephone, managing finances, etc.) 
Grade 3 : Severe or medically significant, but not immediately life-threatening; leading to 
hospitalization or prolonged hospitalization; causing disability; limited self-care activities (ADLs) 
(self-care ADLs include bathing, dressing and undressing, eating, using the toilet, taking 
medications, etc., and are not bedridden) 
Grade 4 : Life-threatening; urgent treatment required 
Grade 5:  AE -related death 
7.2.3.4 Determination of causal relationship of adverse events 
Investigators should use a dichotomous approach to assess the possible association between 
the AE and the study drug, assessing whether the AE is reasonably related to the study drug and 
recording this in the CRF : No (not related) or Yes (related). When assessing causality, the 
following aspects should be considered: 
 
The temporal relationship between the adverse event and the administration of the trial 
drug (including the sequence and reasonable time interval) 
 
Are other medications or treatments associated with adverse events? 
 
Whether the adverse event is consistent with the mechanism of action of the 
investigational drug 

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 
Whether the subject's indications or other underlying diseases/comorbidities may lead to 
the occurrence of adverse events 
 
Whether the adverse event improves or resolves after dose reduction or discontinuation 
of the trial drug (if applicable) 
 
After recovery from the adverse event, whether the adverse event recurs when the trial 
drug is used again (if applicable) 
 
7.2.3.5 Outcome of adverse events 
It can be described as follows: 
 
Recovered: The subject returned to baseline. 
 
Recovering: The event has not yet been fully resolved, but the subject is in the recovery 
stage. 
 
Unrecovered: The event is ongoing, e.g., an irreversible congenital malformation. 
 
Recovered with sequelae: Only if the subject will have long-lasting or lifelong sequelae, 
such as hemiplegia caused by a stroke. 
 
Fatal: The event resulted in the subject's death, and the date of death was the end date of 
the event . 
 
Unknown: The investigator cannot obtain information on the AE outcome, such as the 
subject being lost to follow-up. 
If the outcome of an AE is "recovered", "recovered with sequelae" , or "fatal" , the end date 
of the AE must be recorded. 
7.2.3.6 Collection of adverse events 
All adverse events (AEs) should be collected from the signing of the primary informed 
consent form until the 48-week visit after the subject completes the cell infusion or receives new 
anti-cancer treatment (whichever occurs first). For subjects who underwent leukapheresis but did 
not receive CAR-T cell transfusion, only adverse events reported within 30 days of the relevant 
procedure or treatment (e.g., leukapheresis, lympholysis pretreatment) or the start of new anti-
cancer treatment, whichever occurs first, should be collected. Serious adverse events occurring 
after this collection period and judged by the investigator to be related to the study procedures 
and/or study treatments should also be collected and recorded. 
If adverse events or serious adverse events occurred between the signing of the molecular 
prescreening consent form and the signing of the master informed consent form and were related 
to the prescreening tumor biopsy procedure , these AEs or SAEs needed to be recorded. 
Disease progression is defined as a worsening of the subject's condition due to the primary 
tumor targeted by the investigational drug. Symptoms and signs of disease progression do not need 

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to be recorded as AEs/SAEs. 
7.2.3.7 Follow-up of adverse events 
Adverse events should be followed up until recovery to normal/baseline levels, the subject is 
lost to follow-up or dies, or the investigator deems follow-up unnecessary for reasonable reasons 
(e.g., stabilization of the AE). If an adverse event does not resolve, a reasonable explanation should 
be documented in the original medical record, regardless of whether it is related to the study drug. 
The recovery status and date of the subject's AE or SAE should be recorded in the CRF and medical 
record. Changes in the severity of the adverse event, its causal relationship to the study drug, 
measures taken to address the study drug, therapeutic interventions administered, and outcomes 
should be assessed at each visit (more frequent visits may be necessary). 
7.2.3.8 Serious Adverse Event Reporting 
All SAEs occurring during the study, regardless of whether they are related to the study drug, 
should be reported to the ethics committee as soon as possible upon learning of them, in accordance 
with the requirements of the local ethics committee. Investigators must complete the Serious 
Adverse Event Report Form and submit it to the sponsor within 24 hours of learning of the SAE . 
Serious adverse reactions to active control drugs should be reported to the National Center for 
Drug Evaluation by the clinical trial institution. 
The first reported SAE should contain at least the following information: 
 
Identifiable subject (e.g., subject number); 
 
Suspicious research drugs; 
 
Identifiable source of the report (name of the researcher/reporter or institution); 
 
Other AE related information for reference: 
 If the diagnosis is known, record it as a single disease or syndrome; if the diagnosis 
is unknown, report signs and / or symptoms, avoiding colloquialisms and 
abbreviations; 
 Dates of onset and resolution of the event; 
 severity; 
 Determination of the relationship with the investigational drug; 
 Actions taken and results obtained with the investigational drug; 
 Treatment / remedial measures for the subject 's AE ; 
 Description of the adverse event process (including information on concomitant 
medication, etc.). 
When reporting for the first time, try to complete all the information in the SAE report form. 
The SAE must be recorded and filed with the ethics committee. 

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When filling in the adverse event form of the CRF, researchers will use the National Cancer 
Institute Common Terminology Criteria for Adverse Events (NCI CTCAE 5.0) to judge the 
severity of adverse events ( CRS and ICANS according to the 2019 ASTCT The severity of the 
adverse event should be assessed using the CRC /ICANS grading criteria , and the grading should 
be recorded in the CRF. If the severity of the adverse event changes, the original record information 
should be updated promptly . 
7.2.3.9 Suspected and Unexpected Serious Adverse Reactions (SUSAR) 
suspected and unexpected serious adverse reactions whose nature and severity exceed the 
information already provided in the study brochure of the investigational drug. 
All SUSARs that occur during the study should be reported to the ethics committee as soon 
as possible after becoming aware of them in accordance with the requirements of the local ethics 
committee. 
7.2.3.10 Adverse events of special concern and their management principles 
The trial site must be equipped with necessary medical rescue equipment, emergency 
medications, and emergency measures. If necessary, establish an emergency medical incident 
response team to handle emergency medical incidents and unexpected disasters in accordance with 
relevant standard operating procedures. Closely monitor potential adverse events, especially 
unexpected adverse events, and promptly analyze and communicate them. Complete an adverse 
event observation log. Establish liaison procedures with the hospital's intensive care unit for 
subject transfer and care. Establish communication and exchange between researchers, laboratories, 
and collaborating institutions to ensure timely communication and handling of potential adverse 
events. 
Adverse events associated with CAR-T therapy reported in the literature include cytokine 
release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), 
cerebral edema, cytopenia, cardiac toxicity, tumor lysis syndrome, hemophagocytic 
lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), disseminated intravascular 
coagulation (DIC), off-target toxicity, hypogammaglobulinemia, infectious complications, 
infusion reactions, and allergic reactions. 
Adverse events that may be related to the CLDN18.2 target include acute gastric mucosal 
injury/gastrointestinal bleeding. 
Appendix 5 lists the treatment and response measures for the common adverse events 
mentioned above, which can be used as a reference for researchers. However, they are subject to 
the researchers' actual clinical operations and should be recorded truthfully. 
Non-serious adverse events of special concern do not need to be reported to the sponsor in a 
timely manner. 

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7.2.3.11 Pregnancy 
Pregnancy itself is not considered an AE. If a subject or their partner becomes pregnant 
between the start of study drug administration and W48 of follow-up, regardless of whether the 
subject withdraws from the trial early, the subject should notify the investigator. The investigator 
must complete the " Pregnancy Report Form " and submit it to the sponsor within 24 hours of 
learning of the pregnancy. 
Researchers should provide counseling to female subjects and discuss the risks of continuing 
the pregnancy and the possible effects on the fetus and nursing infant. 
Investigators should follow up on pregnancy outcomes until one month after 
delivery/termination of pregnancy and report the results to the sponsor. If the pregnancy outcome 
is stillbirth, spontaneous abortion, or fetal malformation, it is considered a SAE and must be 
reported according to the SAE timeline requirements. 
7.3 Cellular Kinetics Assessment 
7.3.1 Cellular kinetics evaluation indicators 
PK parameters (PK) were assessed using ddPCR and flow cytometry to assess the expansion 
and persistence of CLDN18.2 CAR-T cells in peripheral blood after IMC002 infusion . Key 
evaluation indicators included: CAR-T cell peak ( peak CAR copy number and peak CAR-T cell 
number in peripheral blood after cell infusion), time to peak ( days to peak CAR copy number and 
peak CAR-T cell number after cell infusion) , AUC (area under the curve of CAR copy number in 
peripheral blood versus visit time from day 0 to 28 ) , T last ( the last time CAR copy number became 
detectable ) , final observable concentration (C last ), expansion rate ( C max /T max ), and persistence 
( from the end of infusion, qPCR was used to measure CAR copy number in peripheral blood at 
each visit until any two consecutive test results were negative or below the limit of detection). The 
duration of IMC002 persistence was recorded from the day of infusion to the first negative result 
or the time when the result fell below the limit of detection . 
7.3.2 Cytokinetic Blood Sample Collection and Testing 
Blood samples were collected before lymphoblastic leukemia (PLL) clearance (within 7 days), 
before IMC002 infusion, 30 minutes ± 5 minutes, 3 days, 7 days, 9 days , 14 days, and 28 days 
after cell infusion, and at W8 , W14 (±7 days), W26 (±7 days), W50 ( ±14 days), and W98 ( ±14 
days) after randomization. Blood samples were collected every 6 months for 2 years after cell 
infusion . Blood samples were collected until disease progression, undetectable CAR copy number 
for two consecutive days after CAR-T cell monitoring reached its peak , death, or other reasons 
for patient withdrawal (whichever occurred first). 
7. 4 Pharmacodynamic evaluation 
7.4.1 Pharmacodynamic evaluation indicators 
The peak concentration and time to peak of cytokines before and after treatment will be 

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evaluated , and the corresponding concentration-time curves will be drawn. 
7.4.2 Pharmacodynamic blood sample collection and testing 
inflammatory factors in the blood before and after treatment , including but not limited to IL-
2, IL-6, TNF-α, INF-γ, acute phase response-related factors CRP, ferritin, etc. 
Pharmacodynamic blood collection is consistent with PK blood collection , with the addition 
of sampling before lympholysis . 
7.5 Immunogenicity Evaluation 
Immunogenicity evaluation : Changes in anti-CAR anti-drug antibodies (ADA) in the blood 
before and after IMC002 treatment. 
ADA testing : Testing should be performed before lymphoblastic effusion (within 7 days of 
purging lymphoblastic effusion), on day 28 after cell infusion , and on days 14 (±7 days), 26 (±7 
days), 50 ( ±14 days) , and 98 (±14 days) after randomization . If CAR copies are still detectable 
in peripheral blood 2 years after cell infusion , ADA testing should be performed every 6 months 
thereafter. If CAR copies are undetectable for two consecutive times after W14 (including testing 
before W14) , in the event of death, withdrawal of informed consent, 15 years after cell infusion , 
or trial termination (whichever occurs first) , ADA testing will not be performed again . 
7.6 RCL detection 
Replication-competent lentivirus testing (RCL testing) : Testing should be performed 
before infusion, at Weeks 14 (±7 days), 26 (±7 days), 50 (±14 days) , and 8 (±14 days) after 
randomization. Blood samples should be collected annually for 2 years after cell infusion until the 
subject is lost to follow-up, dies, withdraws informed consent, 15 years after cell infusion, or trial 
termination (whichever occurs first). If the RCL test is negative within 26 weeks after 
randomization and there are no clinical signs of abnormal lentiviral expansion, blood samples 
collected after Week 24 can be retained and not tested. 
7.7 Lentiviral genome insertion site detection 
Lentiviral genome insertion site detection was performed after IMC002 treatment to assess 
lentiviral insertion site events. Testing was performed before infusion, and at W1 4 (±7 days), W2 
6 (±7 days), W50 (±14 days) , and W9 8 (±14 days) after randomization. Data were collected 
annually for 2 years after cell infusion until the subject was lost to follow-up, died, withdrew 
informed consent, 15 years after cell infusion, or trial termination (whichever occurred first). 
7.8 Other exploratory research indicator tests 
Other exploratory translational medicine indicators include:  
⦁ Detect changes in  
cytokines (such as IL-2 , IL-6 , TNF-α , INF-γ , etc.) before and 
after IMC002 administration before and after treatment . 
 
Additional exploratory testing may be conducted in research centers with appropriate 

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conditions to support the evaluation of changes in biomarkers (such as CLDN18.2, etc.) 
before and after administration of IMC002. 
 
Additional exploratory testing can be performed in research centers with appropriate 
conditions to support the evaluation of changes in CAR-T cell phenotype before and after 
IMC002 administration (at time points with CAR-T expansion, such as if there are 
surplus samples). 
 
In research centers with corresponding conditions, additional exploratory tests can be 
carried out to support the CAR-T expansion, immune cell composition (CD4+/CD8+ 
ratio, memory cell phenotype, etc.) and changes in patient tumor tissues. 
Quality of Life Questionnaire C30 
The EORTC-QLQ-C30 is a 30-item cancer-specific questionnaire consisting of five 
functional scales (physical functioning, role functioning, emotional functioning, social functioning, 
and cognitive functioning ) , nine symptom scales/items (fatigue, nausea/vomiting, general pain, 
dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties ) , and an 
overall health status scale. Higher scores on the functional scales indicate better functioning, while 
higher scores on the symptom scales/items indicate worse symptoms. 
Esophageal-gastric module 25 
The EORTC QLQ-OG25 questionnaire is a 25-item tool that assesses symptoms associated 
with gastric and GEJ cancer. This module includes six scales : dysphagia (3 items) , dietary 
restriction (4 items) , regurgitation (2 items) , odynophagia (2 items) , pain and discomfort (2 
items) , and anxiety (2 items) , as well as 10 individual items : eating in the presence of others, dry 
mouth, taste disturbance, body image, saliva swallowing disorder, choking when swallowing, 
coughing, difficulty speaking, weight loss, and hair loss. For each symptom scale/item, higher 
scores indicate worse symptoms. 
8. Statistical Analysis 
Details of data processing, statistical methods, and result tabulation will be described in detail 
in the Statistical Analysis Plan (SAP). The final version of the SAP will be finalized before the 
database is locked. 
8.1 Statistical analysis population 
8.1.1 Subject enrollment information 
The number and percentage of subjects enrolled and completing the study will be calculated 
for each treatment group. The reasons for withdrawal from the study before and after enrollment 
will be summarized. 
8.1.2 Deviation from the plan 
by dose group and listed by subject. 

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8.1.3 Rejection criteria 
Before statistical analysis of the data, the statisticians and the principal investigator will 
discuss and determine whether to exclude individual cases. In the following situations, the 
statisticians and the investigators should make a comprehensive judgment based on factors such 
as the degree of completion of the trial and the reason for withdrawal, and whether to exclude the 
subject from the per-protocol set, and provide relevant explanations: 
1) Subjects who are found to not meet the inclusion criteria or exclusion criteria after 
participating in the trial and are judged to have committed major protocol violations; 
2) Failure to comply with the trial plan during the trial (poor compliance, such as not having 
used IMC002 or ICT , or samples that cannot be evaluated for efficacy and safety as 
required by the trial protocol, and no data, etc.); 
3) In addition to the above situations, there are other major deviations or violations of the 
protocol during the trial that affect the efficacy and safety of IMC002. 
8.1.4 Analysis Set 
Intention-to-treat (ITT) analysis set included all randomized subjects. 
Modified intention-to-treat analysis set (mITT): all subjects who were randomized and 
received at least one dose of study treatment (IMC002 or ICT). 
Per-Protocol Set (PP): Subjects in the ITT set who did not experience major protocol 
violations that affected the efficacy evaluation and who had at least one efficacy evaluation. Major 
protocol violations that affected the efficacy evaluation will be determined after discussion in the 
blind review meeting before the database is locked. 
Safety Analysis Set ( SS ): includes all subjects who were randomized and received at least 
one dose of study treatment. Subjects will be analyzed based on the study treatment they received 
(IMC002 or ICT). 
Cell Kinetics Set ( PKS ): All subjects who received IMC002 cell infusion, had at least one 
valid PK data, and did not experience protocol deviations that seriously affected the PK evaluation 
will be used for PK analysis. 
Pharmacodynamic analysis set: All subjects who received IMC002 cell infusion and had 
baseline and at least one post-baseline evaluable pharmacodynamic index examination results. 
Immunogenicity analysis set: All subjects who received IMC002 cell infusion and had at least 
one post-dose ADA result. This dataset was used for immunogenicity analysis. 
Crossover analysis set: The crossover analysis set included subjects randomized to the control 
group who crossed over to receive IMC002 cell infusion. All analyses of safety parameters 
collected after subjects received crossover treatment were performed using this analysis set. 

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8.2 General principles 
All statistical analyses will be performed using SAS version 9.4 or later. Generally, continuous 
variables will be described using the number of cases, mean, median, standard deviation, minimum, 
and maximum values; categorical and ordinal variables will be described using the frequency and 
percentage of each category or level. Time-to-event metrics will be analyzed using the Kaplan-
Meier method. The median, 25th and 75th percentiles, and their 95% confidence intervals will be 
calculated for each cohort, and Kaplan-Meier curves will be plotted. Unless otherwise specified, 
missing values will not be included in the calculation of percentages. 
8.3 Demographics , medical history, baseline characteristics, and concomitant medications 
The FAS will be used to summarize demographic information and baseline characteristics. 
Demographic information and baseline characteristics, medical history, and concomitant 
medications will be analyzed using descriptive statistics (number of cases [n], mean, SD, median, 
minimum, and maximum) or frequency tables. 
Medical history will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA); concomitant medications will be coded according to the World Health Organization 
Drug Dictionary Enhanced (WHO-DDE) based on the Anatomical Therapeutic and Chemical 
Classification (ATC) system. Medical history and concomitant medications will be summarized in 
the FAS. 
The version of the dictionary used for encoding shall be described in the CSR. 
Demographic information and baseline characteristics included only those collected/assessed 
during the screening period/baseline. 
8.3.1 Subject demographics 
The demographic information of the subjects included: age, height, weight, ethnicity, and 
gender. 
8.3.2 Medical and treatment history 
Medical history: This refers to the subject's previous history of cancer and cancer treatment 
history. Treatment includes but is not limited to surgical treatment, chemotherapy, radiotherapy, 
drug therapy, and other treatments. In addition to cancer history, other past medical history or 
treatment history that the researcher considers important may also be recorded as appropriate. 
Treatment history: Tumor diagnosis and treatment history, including cancer-related medical 
history and treatment history, as well as previous biomarker expression; a complete history of past 
medical history, current medical history, and treatment history was collected during the screening 
period. Only new medical history was recorded during follow-up visits. 
The subject's previous surgical history or non-tumor chronic disease, which has been cured 
or recovered to a state of no clinical significance during the screening period, will be recorded as 
past medical history. 

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Allergy history: Previous allergy to immunotherapy, allergy to related drugs such as 
tocilizumab, cyclophosphamide, fludarabine, or albumin-paclitaxel, allergy to IMC002 
components such as albumin, DMSO, etc., or other severe allergic history. 
8.3.3 Concomitant diseases and concomitant medications 
Concomitant diseases and concomitant medications that existed in the subjects and still 
existed after entering the trial, excluding tumor-related diseases and treatments. 
Any non-tumor chronic disease suffered by the subject that is still clinically significant during 
the screening period or any clinically significant abnormal symptoms, signs, laboratory or auxiliary 
examination abnormal results related to non-study diseases discovered after the signing of the ICF 
and before the subject is enrolled in the study for leukocyte apheresis should be recorded as a 
concomitant disease: Abnormal results during the screening period caused by the study procedures 
should be recorded as AEs. 
8.4 Medication Adherence 
Treatment adherence was summarized using descriptive statistics (number of cases [n], mean, 
SD, median, minimum, and maximum) and/or frequency tables. 
Medication compliance (%) will be calculated as actual dosage/planned dosage × 100%. 
8.5 Efficacy analysis 
The primary endpoint of this study was progression -free survival (PFS), as assessed by BIRC. 
PFS was defined as the time from the date of randomization to the first documented disease 
progression (as assessed by BIRC according to RECIST 1.1) or death from any cause . PFS analysis 
was based on the ITT cohort. If two or more consecutive tumor assessments were missed before 
the date of a PFS event, PFS was censored to the date of the last evaluable tumor assessment before 
the missed assessment. The Kaplan-Meier method was used to calculate the median PFS, quartiles, 
and 95% confidence intervals (CIs) for each group. Censorship was summarized, and KM curves 
were plotted. 
The stratified log-rank test was used to compare PFS between the two groups. A stratified 
proportional hazards regression model (Cox Proportional Hazards Regression Model) was used to 
estimate the hazard ratio (HR) and its 95% CI for the experimental group versus the control group 
(with the exact method used for identical event times). The stratification factors used were the 
same as those used at randomization. Sensitivity analyses were also performed using data from the 
mITT and PP sets. 
The final analysis of PFS efficacy was performed approximately 3 months after the 
completion of enrollment of the subjects when at least 86 PFS events were observed. 
The primary estimated objective PFS analysis will take into account different concomitant 
events as follows: 
•  Discontinuation of study treatment: PFS analysis will take into account all tumor 

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assessments and deaths, regardless of discontinuation of study treatment for any reason (treatment 
strategy)  
• Patients who cross treatment (for patients in the control group) or start new anticancer 
treatment (for all patients) will be treated using a hypothetical strategy whereby PFS will be 
censored at the last adequate assessment date or the date of randomization before the cross 
treatment or start of new anticancer treatment if no PFS event was observed before the cross 
treatment or start of new anticancer treatment. 
• Any unforeseen concomitant events, such as those arising from a public health emergency, 
will be addressed through therapeutic strategies. 
Treatment of missing values not related to concurrent events 
The censoring rules for PFS follow the RECIST 1.1 guidelines and will be further detailed in 
the statistical analysis plan (SAP). 
Sensitivity analysis 
As a sensitivity analysis, the two treatment groups will be compared using a nonstratified log-
rank test. A nonstratified Cox model will be used to generate the PFS hazard ratio and 95% 
confidence interval based on BIRC review. The sensitivity analysis estimates are the same as the 
key secondary estimates. Additional sensitivity analyses and estimates, if any, will be detailed in 
the SAP. 
Supporting analysis 
Investigator-assessed PFS will be analyzed in the ITT using a stratified Cox model, and 
treatment effects will be summarized as hazard ratios with 95% confidence intervals. Kaplan-
Meier curves, medians, and 95% confidence intervals will be provided for each treatment group. 
In the ITT, hazard ratios and 95% confidence intervals for PFS based on BIRC review will be 
obtained from stratified and covariate-adjusted Cox models including sex and age. The final list of 
covariates included in the model will be provided in SAP. 
If statistical significance is achieved in the primary analysis of PFS, subgroup analyses will 
be performed to assess the homogeneity of the treatment effect across demographics and baseline 
disease characteristics. Different thresholds or variables used for subgroup analyses will be 
detailed in the SAP. The number of subjects censored in the PFS analysis and the reasons for 
censoring will be summarized by treatment group. 
Analyses supporting secondary objectives 
Secondary efficacy endpoints will be assessed using ITT. 
OS is defined as the interval from the date of randomization to the date of recorded death 
from any cause. For subjects whose deaths were not recorded, those who had not died by the 
analysis cutoff date were censored at the time of last contact. The analysis will be based on data 

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from the ITT population. The OS analysis will provide Kaplan-Meier curves, medians, and 95% 
confidence intervals for OS in each treatment group . A stratified Cox model will be used to 
calculate the hazard ratio (HR) for OS and its 95% confidence interval. 
The ORR is defined as the proportion of subjects achieving a best overall response (BOR) of 
complete response (CR) or partial response (PR). Tumor response status was assessed by the BIRC 
according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Confirmation was 
required by repeat assessment at least four weeks after the initial achievement of CR or PR 
response criteria. The disease control rate (DCR) was defined as the proportion of subjects 
achieving a BOR of CR, PR, SD, or non-CR/non-PD. DCR was analyzed using the same 
conventional analysis methods as ORR . 
Duration of response (DOR) was defined as the duration from the date of the first documented 
response (CR or PR) to the date of the first documented disease progression or all-cause death. If 
a patient had no events, the DOR was censored at the date of the last adequate tumor assessment. 
Subjects whose BOR never achieved a CR or PR were excluded from the analysis. The Kaplan-
Meier method was used to estimate the DOR distribution function. The median DOR and its 95% 
CI are presented by treatment group. 
Time to response (TTR), defined as the time from the date of randomization to the date of the 
first documented response (CR or PR, which must then be confirmed), was analyzed descriptively. 
The above analyses will be performed based on BIRC assessment and local investigator 
assessment (according to RECIST 1.1). 
The BOR for each subject was determined according to the order of overall response (lesion) 
as follows: 
• CR = at least two CRs before disease progression, with at least 4 weeks between the two 
CRs. 
• PR = at least two PRs before disease progression, with at least 4 weeks between the two 
PRs (and not meeting CR criteria). 
• SD = SD in at least one assessment > 5 weeks after randomization (and not meeting CR or 
PR criteria). 
• Non-CR/non-PD = non-CR/non-PD (and does not meet CR, PR, or SD criteria) in at least 
one assessment > 5 weeks after randomization. 
• PD = progressive disease after randomization (and not meeting CR, PR, SD, or non-
CR/non-PD criteria). 
• Not evaluable = all other lesions (i.e., not meeting confirmed CR or PR criteria or non-
CR/non-PD after > 5 weeks and no SD, or no early progression) 
Analysis Timing: The final analysis of PFS efficacy will be performed approximately 3 

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months after completion of enrollment when at least 86 PFS events have been observed . The 
interim analysis of OS will be performed at the time of the final analysis of PFS. The final analysis 
of OS efficacy will be performed approximately 10 months after the last subject is randomized 
when at least 112 deaths have been observed. 
8.6 Security Analysis 
All listings and tables are presented by treatment group using the safety set. 
Exposure to each study drug was summarized descriptively, including the number of cycles 
received (number and percentage of patients), duration of exposure (days), total cumulative dose 
per patient, dose intensity, and relative dose intensity. 
Adverse events (AEs) were coded verbatim using Medical Dictionary for Drug Regulatory 
Activities (MedDRA®) terms and graded according to NCI CTCAE 5.0 (except for CRS and 
ICANS, which were assessed according to the 2019 ASTCT CRS/ICANS grading criteria). All 
treatment-emergent adverse events (TEAEs) were summarized. 
Identify outliers in clinical laboratory data. Selected laboratory data are summarized by level. 
Changes in vital signs are also summarized by visit number. 
8.7 Cell kinetic analysis 
The main cellular kinetic parameters of each subject, including peak concentration (C max ), 
time to peak ( T max ), area under the concentration-time curve (AUC), final observable 
concentration (C last ), last detectable time (T last ), and expansion rate (C max /T max ), were calculated using 
the non-compartmental model of WinNonlin 8.2 (or newer ) pharmacokinetic software. 
Cellular kinetic analysis was performed based on PKS. Descriptive statistical analysis of 
blood CAR copy number versus time data was performed according to the planned sampling time. 
The arithmetic mean, standard deviation, median, maximum, minimum, coefficient of variation, 
and geometric mean of blood CAR copy number at each time point were calculated. Individual 
and mean blood CAR copy number versus time curves were plotted. 
8.8 Pharmacodynamic analysis 
Based on the pharmacodynamic analysis set, descriptive statistical analysis was performed on 
the pharmacodynamic indicators at each visit time point, and the mean, standard deviation, median, 
minimum value, maximum value, geometric mean, and geometric mean coefficient of variation 
were reported. 
If necessary, additional PK analyses can be performed. 
Exposure-response (efficacy or safety endpoint) analyses may be performed if supported by 
data. 
8.9 Immunogenicity analysis 
Immunogenicity samples will be collected for this study as described in the evaluation plan. 

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Immunogenicity results will be summarized by number of patients and percentage using 
descriptive statistics. The incidence of positive ADA and neutralizing ADA will be reported in 
patients with detectable ADA. The impact of immunogenicity on PK, efficacy, and safety will be 
assessed if data permit. 
8.10 Translational Research 
Translational studies will be conducted to analyze relevant biomarkers and their correlation 
with clinical outcomes. 
8.11 Analysis of Correlation between Companion Diagnostic Reagents and Drug Efficacy 
Claudin 18.2 protein expression was detected using a Claudin 18.2 antibody reagent 
(immunohistochemistry) to conduct a drug efficacy analysis to evaluate the effectiveness of 
IMC002 in treating patients with gastric or gastroesophageal junction adenocarcinoma that is 
positive for Claudin 18.2 expression. 
8.12 Sample Size and Interim Analysis 
8.12.1 Sample size 
This study used BIRC-assessed PFS as the primary endpoint. Early study data indicate that 
the median PFS (mPFS) observed in the IMC002 trial arm is approximately 6.9 months, while 
historical data indicate that the mPFS in the control arm (investigator's choice of treatment) ranges 
from 1.6 to 2.6 months. This study assumed mPFS of 5.2 and 2.6 months in the trial and control 
arms, respectively, and a true PFS hazard ratio ( HR: IMC002 vs. investigator's choice of treatment) 
of 0.5. With a power of 85%, a one-sided type I error rate of 0.025, and a 2:1 randomization ratio 
between the trial and control arms , the final analysis required approximately 86 events. 
Assuming complete enrollment within 12 months, the minimum follow-up is 3 months. 
The sample size was also calculated based on the key secondary endpoint of OS . Assuming 
an exponential distribution for OS, the median OS in the control group was approximately 6 
months, and the true OS hazard ratio (HR: IMC002 vs. investigator-selected treatment) was 0.56. 
OS will be tested at a one-sided 0.025 test level. With an assumed power of 80 % , the final analysis 
of OS will be conducted approximately 10 months after the last randomized subject, when 
approximately 112 events have been observed. 
Considering the 20% dropout rate of subjects, approximately 150 subjects need to be enrolled, 
with at least 100 subjects in the trial group. 
8.12.2 Interim Analysis 
The interim analysis of OS will be conducted at the same time as the final analysis of PFS . 
The O'Brien-Fleming spending function (Lan-Demets algorithm) will be used to calculate the 
significance level for both the interim and final analyses of OS. Gate keeping will be used to control 
type I error. Hypothesis testing for the key secondary endpoint of OS will only be conducted if the 
hypothesis test for the primary endpoint of PFS is significant . 

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8.12.3 Independent Data Monitoring Committee (IDMC) 
An IDMC will be established for this study. The IDMC will consist of at least three experts, 
including clinical and statisticians. Interim analyses will be conducted by the IDMC. The IDMC 
will evaluate the efficacy and safety data at the interim analysis in accordance with its protocols 
and make recommendations to the sponsor regarding trial continuation, protocol modification, or 
trial termination. 
9. Data quality and management 
9.1 Data Quality Assurance 
The sponsor or its designated personnel will conduct an on-site visit to the research center to 
verify the qualifications of the investigator, inspect the center facilities, and inform the investigator 
of the responsibilities and procedures to be followed to ensure the completeness and accuracy of 
the records. 
The investigator should fully and accurately record study-related observations and other data 
for each subject in the medical record. All information recorded in the CRF should be consistent 
with the subject's source documents (e.g., medical records). 
9.1.1 Data management and quality control 
All data collected by the research center and its laboratories will be recorded in the CRF. 
Once the clinical data in the CRF is transferred to the data management party and the database is 
frozen, changes to the data will be recorded as an audit trail. The reason for the change, the name 
of the person who made the change, and the time and date of the change will be recorded as an 
audit trail record. 
During routine monitoring, the relevant monitor or data manager will raise questions 
regarding the CRF. Authorized personnel at the research center will respond to the questions sent 
to the investigator. The name of the person who responded to the question, along with the time and 
date of the response, should be recorded. Once all raw data have been verified and all questions 
have been resolved, the monitor or data manager will freeze the database. 
9.2 Case Report Form and Source Documents 
All data obtained during the study should be entered into the CRF promptly. The source files 
for all data entered into the CRF should be kept in the medical record. These source files typically 
include laboratory tests, electrocardiograms, and echocardiography. Data entered directly into the 
CRF will be considered raw data. Clinical monitors will verify the raw data entered into the CRF 
with the source files during site monitoring. After completing the verification, the clinical monitor 
will discuss missing and unexplained data with the investigator. 
9.2.1 Data Collection 
The researcher (and appropriate authorized personnel) will be given access to the CRF, and 
only the researcher and authorized personnel can enter and correct data on the CRF. 

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The investigator (or appropriately authorized personnel) should complete a CRF for each 
enrolled subject, reflecting their findings from the most recent study observation. Therefore, the 
CRF should be completed as soon as possible after the subject completes a visit or assessment. The 
investigator should verify the accuracy of the data entered on the CRF. If some assessments cannot 
be performed, or if specific information is unavailable, inapplicable, or unknown, the investigator 
should indicate this in the CRF. 
The researcher must sign the CRF upon completion. 
The amount of study drug used by each subject and any dose changes will be recorded on the 
CRF. 
9.3 Monitoring of raw data 
During the study, the monitor will conduct site visits to verify protocol compliance, CRF entry, 
subject medical history, medication counts, and compliance with relevant regulatory requirements. 
CRF entries will be reconciled with the original data. This medical history verification will be 
conducted in a manner that protects subject confidentiality. 
CRF entries are reviewed for completeness and clarity and compared with the original data 
to monitor study progress. Additionally, regulatory authorities and the EC's clinical quality 
assurance department may review the original data and/or conduct on-site audits or inspections at 
the site. Audits or inspections provide direct access to the original data; parties with direct access 
will take every measure to ensure data and medical confidentiality. 
9.4 Data Processing 
The data review and data handling plan includes specific requirements for verifying the 
consistency and authenticity of the data, as well as principles for handling data with obvious errors. 
The database will be updated based on signed corrections. 
Previous medications and concomitant medications will be coded according to WHO-DDE 
using ATC categories, and past/present medical history and AEs will be coded according to 
MedDRA. 
The version of the encoding dictionary will be described in the CSR. 
9.5 Archiving of research records 
Researchers should retain clinical research data for 5 years after the completion of the clinical 
study. Sponsors should retain clinical research data for 5 years after the study drug is approved for 
marketing. 
9.6 Good Practices for Clinical Trials of Drugs 
This study protocol will be carried out in accordance with GCP, the Declaration of Helsinki 
(2008) and local regulatory requirements. 

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9.7 Informed Consent 
In accordance with local laws and regulations, a signed and dated ICF will be obtained from 
the subject before any study-related procedures begin. The researcher will retain the original signed 
ICF as a study document. The signing date of the ICF will be recorded in the CRF. 
If the protocol needs to be amended, the ICF may need to be amended to reflect the updated 
information in the protocol. If the ICF is amended, it must be submitted to the EC and approved in 
writing, and signed by the subjects who will be subsequently enrolled and are currently in the 
study. 
9.8 Plan Approval and Amendment 
In accordance with local regulations, the study protocol and/or other relevant documents will 
be approved by the EC/competent authority before the study begins, ensuring that all ethical and 
regulatory requirements are met before the first subject is enrolled. 
This study will be conducted strictly in accordance with this protocol. Any amendments to 
the protocol must be approved in writing by the relevant personnel and submitted to the 
EC/IRB/competent authority for approval before implementation. 
Changes in management (that do not affect the benefit/risk ratio for the subjects) do not 
require a formal protocol amendment. Each version of the protocol amendment will be distributed 
to all protocol recipients with corresponding instructions. 
9.9 Research cycle 
The completion of this study period was defined as the last subject completing the last visit 
specified in the protocol. 
Completion of the study cycle for each subject is defined as the completion of the last visit 
specified in the protocol. After signing the master informed consent form, each subject, based on 
treatment group, will undergo a screening period, treatment and follow-up period, exit visit, and 
survival/long-term follow-up. 
9.10 Early Termination of the Study 
If the investigator, sponsor, or monitor becomes aware of a situation or event that could 
endanger the subjects if the study continues, the study may be terminated after discussion among 
the relevant personnel. 
The study may be terminated early for the following reasons, but is not limited to: 
 
Unexpected, significant or unacceptable risks to enrolled subjects 
 
The sponsor decides to suspend or stop the development of the drug 

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9.11 Confidentiality 
All findings and documents related to the study will be treated as confidential. The researcher 
and his/her research team members shall not disclose such information without the written consent 
of the sponsor. 
Ensure that research subjects remain anonymous. Subjects should be identified in CRFs and 
submissions by subject number, initials, and/or date of birth, but not by their names. Researchers 
should maintain confidentiality regarding documents that do not need to be shared but that identify 
the subject (e.g., signed ICFs). 
9.12 Liability and Insurance 
The sponsor will provide insurance for the subjects participating in this study in accordance 
with legal requirements and will bear the cost of treatment and corresponding financial 
compensation for the subjects who suffer damage related to the study drugs or research process. 
9.13 Publishing Policy 
By signing this study protocol, the investigator agrees that the results of this study may be 
used for domestic or international registration applications, publication, or disclosure to medical 
professionals. If necessary, the investigator's name, address, qualifications, and responsibilities in 
the study will be disclosed to regulatory authorities. 
10. Research Monitoring and Project Management 
10.1 Study Monitoring Plan 
The study will be monitored according to the monitoring plan. Investigators will allocate 
sufficient time to cooperate with monitoring activities. Investigators will also ensure that the monitor 
or other quality assurance reviewers have access to all study-related documents and methods for 
accessing study-related facilities (such as pharmacies, diagnostic laboratories, etc.), as well as 
sufficient space for on-site monitoring. 
10.2 Audit and Inspection 
The researcher will allow the research-related ethics committee, government regulatory agencies, 
and quality assurance groups to monitor, review, and inspect all research-related documents (such as 
source documents, regulatory documents, data collection tools, research data, etc.). The researcher 
will ensure the capacity of research-related facilities (such as pharmacies, diagnostic laboratories, etc.). 
Research participation in this study means that it will be subject to inspection by government 
regulatory agencies and relevant quality assurance offices. 
10.3 Clinical Monitor 
The clinical monitor will conduct routine site monitoring and review all CRFs and 
corresponding source documents for each subject at a mutually convenient time during and after the 
study. During site monitoring, the monitor will ensure that the site has appropriate study-related 

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documentation, provides training and GCP guidance to investigators and other staff involved in the 
study, and ensures that appropriate facilities and sufficient professional staff are available. 
Regular monitoring during the study allows researchers to assess study progress and identify 
potential issues. The monitor will ensure that submitted data is accurate and consistent with source 
documents; review and properly store research products; obtain and archive informed consent from 
subjects; confirm that subjects entering the study meet the study inclusion and exclusion criteria; 
and ensure that all necessary documents required by GCP are properly stored. 
11. Ethical Standards and Informed Consent 
1.1 . Review by the Ethics Committee 
This study was conducted in compliance with Good Clinical Practice (GCP), the current 
Declaration of Helsinki, relevant laws and regulations, and the review opinions of the ethics 
committee. 
Before the study begins, researchers /institutions should obtain written approval from the 
independent ethics committee for the study protocol, informed consent form, subject recruitment 
procedures, and other written materials to be provided to subjects. During the study, any additions 
or revisions to the study protocol, informed consent form, etc. must be approved in writing by the 
independent ethics committee or filed. 
11.2 Informed Consent 
During the clinical research process, if any serious adverse events or unexpected adverse 
events related to clinical research safety occur and may affect the safety of the subjects and the 
implementation of the research, the researcher must inform the ethics committee in accordance 
with relevant regulatory requirements. 
The researcher is responsible for explaining to each subject the study's objectives, methods, 
procedures, benefits and potential risks, available treatment options, and their rights and 
obligations. The researcher should inform each subject that they have the right to withdraw from 
the study at any time without any personal harm. The researcher will recommend alternative 
treatments based on their individual circumstances. 
Before any study-related procedures begin, written informed consent must be obtained from 
the subject. Before obtaining informed consent, the researcher or their designee should provide the 
subject with sufficient time and opportunity to inquire about the details of the study and sufficient 
time to decide whether to participate. The informed consent process must be documented in the 
original medical record. The informed consent form must be dated and signed by each subject, 
their legal guardian or proxy, and the researcher conducting the informed consent process. One 
original copy of the signed informed consent form should be retained by the subject and one by 
the study center. 

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If any information related to the subject's willingness to continue participating in the study is 
obtained during the study, the subject must be notified in a timely manner to confirm whether the 
subject is willing to continue participating. 
The revised informed consent form needs to obtain ethical approval before it can be provided 
to the subjects. 
By signing the informed consent form, the subjects must also agree to allow the drug 
regulatory authorities, auditors and authorized clinical monitors to verify the original data and 
information obtained about the clinical research, and the reviewers must abide by the 
confidentiality statement. 
11.3 Confidentiality of subjects 
In this study, researchers must protect the privacy of the subjects. Data protection and privacy 
regulations must be followed when collecting, transmitting, processing, and storing subject data. 
After signing a written informed consent form, the subject will be given a unique screening 
number, which will serve as the subject's identifier in the study and database. All subject data 
collected in the study will be stored according to the subject number. Researchers can link study 
data to individual subjects using the identity information stored at the center. Monitoring, audit, 
and drug regulatory authorities must ensure that they have access to each subject's original medical 
data during inspections, while strictly protecting the subject's privacy. 
1 2．Paper publication 
As the sponsor, IMUF holds exclusive rights to this study. The authors and manuscript reflect 
collaboration among multiple researchers, research centers, and IMUF staff. Authorship was 
determined in consultation with the researchers before the manuscript was written. Researchers 
should not disclose trial results in any form without the sponsor's consent. 
13. References 
1. 
Freddie, Bray,Mathieu, Laversanne,Hyuna, Sung et al. Global cancer statistics 2022: GLOBOCAN 
estimates of incidence and mortality worldwide for 36 cancers in 185 countries.[J] .CA Cancer J Clin, 
2024, 74: 0. 
2. 
NCCN guidelines, gastric cancer 2024 v4;  
3. 
CSCO Guidelines for the Diagnosis and Treatment of Primary Gastric Cancer 2024 
4. 
Hansjochen, Wilke,Kei, Muro,Eric, Van Cutsem et al. Ramucirumab plus paclitaxel versus placebo plus 
paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction 
adenocarcinoma (RAINBOW): a double-blind, randomized phase 3 trial.[J] .Lancet Oncol, 2014, 15: 0. 
5. 
Rui-Hua, Xu, Yanqiao, Zhang, Hongming, Pan et al. Efficacy and safety of weekly paclitaxel with or 
without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal 
junction adenocarcinoma (RAINBOW-Asia): a randomized, multicentre, double-blind, phase 3 
trial.[J] .Lancet Gastroenterol Hepatol, 2021, 6: 0. 
6. 
Shuichi, Hironaka, Shinya, Ueda, Hirofumi, Yasui et al. Randomized, open-label, phase III study 

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comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal 
metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 
4007 trial.[J] .J Clin Oncol, 2013, 31: 0. 
7. 
Keun-Wook, Lee,Chi Hoon, Maeng,Tae-You, Kim et al. A Phase III Study to Compare the Efficacy and 
Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed 
in First-line Therapy (KCSG ST10-01).[J] .Oncologist, 2018, 24: 0. 
8. 
Jin, Li,Shukui, Qin,Jianming, Xu et al. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of 
Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the 
Stomach or Gastroesophageal Junction.[J] .J Clin Oncol, 2016, 34: 0. 
9. 
Sahin U, et al . Claudin-18 splice variant 2 is a pan-cancer target suitable for therapeutic antibody 
development [J]. Clin Cancer Res. 2008, 14: 7624–34. 
10. Sahin U, et al .Zolbetuximab combined with EOX as first-line therapy in advanced CLDN18.2+ gastric 
(G) and gastroesophageal junction (GEJ) adenocarcinoma:Updated results from the FAST trial. J Clin 
Oncol 2019;37 4 Suppl:16., 
11. Zhan X, et al . Phase I trial of Claudin, 18.2-specific chimeric antigen receptor T cells for advanced gastric 
and pancreatic adenocarcinoma. J Clin Oncol 2019;37:2509. 
12. Changsong, Qi,Chang, Liu,Jifang, Gong et al. Claudin18.2-specific CAR T cells in gastrointestinal 
cancers: phase 1 trial final results.[J] .Nat Med, 2024, 30: 0. 
13. T u reci O, et al . A multicentre, phase IIa study of zolbetuximab as a single agent in patients with 
recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study. 
Ann Oncol 2019;30:1487-95. 
14. Changsong Qi, et al. Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial interim 
results. Nat Med. 2022; 28(6): 1189–1198.  

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14. Appendix 
1 4 .1 Appendix 1 RECIST 1.1 criteria for evaluating response to treatment in solid tumors 
The following translation is for researchers' reference. 
Original English text: Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation 
criteria in solid tumors: Revised RECIST Guideline (version1.1). Eur J Cancer. 2009 Jan; 45(2): 
228-47. 
1. Measurement of tumor lesions 
1. Definition of baseline tumor lesions 
Tumor lesions were categorized as measurable lesions (at least one measurable lesion) at 
baseline: lesions that could be accurately measured using conventional techniques, with a diameter 
≥ 20 mm or ≥ 10 mm on spiral CT. Non-measurable lesions were defined as all other lesions 
(including small lesions with a diameter < 20 mm on conventional techniques or < 10 mm on spiral 
CT), including bone lesions, meningeal lesions, ascites, pleural effusion, pericardial effusion, 
inflammatory breast cancer, lymphangitic carcinomatosis of the skin or lung, and abdominal 
masses and cystic lesions that could not be diagnosed or followed up by imaging. 
2. Measurement method 
1) The same techniques and methods were used to assess lesions at baseline and follow-up. 
2) Clinically superficial lesions such as palpable lymph nodes or skin nodules can be considered 
measurable lesions, and color photographs with a ruler should be used for skin lesions. 
3) Chest X-ray: A clearly defined lesion can be used as a measurable lesion, but CT scan is best 
used. 
4) CT and MRI: CT and MRI are currently the best and most repeatable methods for identifying 
measurable target lesions and evaluating treatment efficacy. For the chest, abdomen, and 
pelvis, CT and MRI scans are performed using 10 mm or thinner slices, while spiral CT scans 
are performed using 5 mm continuous slices. Special protocols are used for the head, neck, 
and other specific areas. 
5) Ultrasound examination: When the endpoint of the study is objective tumor efficacy, 
ultrasound cannot be used to measure tumor lesions. It can only be used to measure superficial 
palpable lymph nodes, subcutaneous nodules and thyroid nodules. It can also be used to 
confirm the complete disappearance of superficial lesions after clinical examination. 
6) Endoscopy and laparoscopy: As objective tumor response assessments, they have not yet been 
widely and adequately used and are only used in controversial lesions or in high-level research 
centers with clear validation purposes. Biopsy specimens obtained with these methods can 
confirm pathologically confirmed CR. 
7) Tumor markers: They cannot be used alone to determine efficacy. However, if tumor markers 

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were elevated before treatment, all markers must return to normal for clinical evaluation of a 
complete response (CR). Disease progression requires that an increase in tumor markers be 
accompanied by visible lesion progression. 
8) Cytology and histopathology: In rare cases, cytology and histopathology can be used to 
differentiate between complete response (CR) and partial response (PR) and to distinguish 
between benign lesions after treatment and residual malignant lesions. Any effusion that 
occurs during treatment requires cytology to differentiate between remission, stability, and 
progression of the tumor. 
II. Evaluation of Tumor Response 
1. Baseline evaluation of tumor lesions 
To establish the overall tumor burden at baseline, against which subsequent measurements 
will be compared, at least one target lesion should be measurable, with limited, isolated lesions 
requiring histopathological confirmation. 
1) Measurable target lesions should represent all affected organs, with a maximum of two lesions 
per organ and a maximum of five lesions total. These lesions should be measured and recorded 
at baseline. Target lesions should be selected based on their long diameter size and 
reproducible measurability. The sum of the diameters of all target lesions (including the 
longest diameter of non-nodal lesions and the short diameter of nodal lesions) will be reported 
as the baseline diameter sum. If lymph node diameters are included, as mentioned above, only 
the short diameter will be included. The baseline diameter sum will serve as the reference 
value for the baseline disease level. 
2) Non-target lesions: All other lesions should be treated as non-target lesions and recorded at 
baseline. Lesions that do not need to be measured should be noted for their presence or 
disappearance during follow-up. 
2. Criteria for remission 
1) Evaluation of target lesions: 
• 
Complete remission (CR) : After treatment, all target lesions of the subject disappear, 
the short diameter of all pathological lymph nodes (including target nodules and non-
target nodules) must be reduced to <10 mm, and tumor markers return to normal. 
• 
Partial response (PR ): After treatment, the sum of the target lesion diameters of the 
subject is reduced by ≥30% compared with the baseline level. 
• 
Progressive disease (PD) : After treatment, the subject develops ≥1 new lesion or the 
minimum sum of the diameters of all target lesions is used as a reference, and the relative 
increase in the sum of diameters is ≥20% (if the baseline measurement value is the 
smallest, the baseline value is used as a reference); in addition, the absolute increase in 
the sum of diameters must be ≥5 mm. 

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• 
Stable disease (SD) : After treatment, the degree of reduction and increase of target 
lesions in the subjects is between PD and PR, and the minimum sum of diameters can be 
used as a reference. 
2) Evaluation of non-target lesions: 
• 
CR : All non-target lesions disappear, tumor marker levels return to normal, and all lymph 
nodes are non-pathological in size (short diameter <10 mm). 
• 
SD : One or more non-target lesions and/or tumor markers persist above normal levels. 
• 
PD : appearance of one or more new lesions and/or progression of non-target lesions. 
3. Overall efficacy evaluation 
The best overall response is the best response documented from the beginning of the trial to 
the end of the trial, taking into account any necessary conditions for confirmation. Sometimes a 
response occurs after the end of treatment, so the protocol should clarify whether a response after 
the end of treatment is considered in the best overall response. The protocol must clarify how any 
new treatment before progression affects the best response. The patient's best response depends 
primarily on the results of the target and non-target lesions and the manifestation of new lesions. 
It also depends on the nature of the trial, protocol requirements, and outcome measures. 
Specifically, in non-randomized trials, the response is the primary goal, and confirmation of a PR 
or CR is necessary to determine which is the best overall response. 
• 
Time point reaction 
It was assumed that a response would occur at the specific time points for each regimen. 
Appendix Table 1 provides a summary of the overall response at each time point for patients with 
measurable disease at baseline. For patients without measurable disease (no target lesions), 
assessments can be found in Appendix Table 2 . 
Assessment of Best Overall Response When Confirmation of Complete or Partial Response 
is Required: A complete or partial response can be declared only if each subject meets the trial-
specified criteria for a partial or complete response and a subsequent confirmation of response is 
performed as specifically mentioned in the protocol at a later time point (generally four weeks 
later). In this case, the best overall response is described in Table 3 in the Appendix . 
Appendix Table 1Time Point Response: Subjects with Target Lesions (Including or Excluding Non-
Target Lesions) 
Target Lesion 
Non-Target Lesion 
New Lesion 
Overall Response 
CR 
CR 
No 
CR 
CR 
Non-CR/Non-PD 
No 
PR 
CR 
Not evaluable 
No 
PR 

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PR 
Non-progressive or not fully 
evaluable 
No 
PR 
SD 
Non-progressive or not fully 
evaluable 
No 
SD 
Not fully evaluable 
Non-progressive 
No 
NE 
PD 
Any 
Yes/No 
PD 
Any 
PD 
Yes/No 
PD 
Any 
Any 
Yes 
PD 
 
Abbreviations: 
CR = Complete Response PR = Partial Response SD = Stable Disease PD = Progressive Disease NE 
= Not Evaluable 
Appendix Table 2Time Point Response - Subjects with Non-Target Lesions Only 
 
Note: For non-target lesions, "non-CR/non-PD" refers to an efficacy superior to SD. Because SD is 
increasingly used as an endpoint for evaluating efficacy , the term "non-CR/non-PD" was developed to address 
situations where no measurable lesions are specified. For ambiguous progression findings (e.g., very small, 
indeterminate new lesions; cystic or necrotic changes in existing lesions), treatment can be continued until the 
next evaluation. If disease progression is confirmed at the next evaluation, the progression date should be the 
date of the previously suspected progression. 
Appendix Table 3Best overall response required for confirmation of CR and PR efficacy 
Note: CR means complete remission, PR means partial remission, SD means stable disease, PD means 
progressive disease, and NE means not evaluable. Superscript "a": If a CR actually occurs at the first time point, 
and any disease appears at a subsequent time point, then even if the subject's efficacy meets the PR criteria 
relative to baseline, the efficacy evaluation at the subsequent time point will still be PD (because the disease will 
reappear after CR). The best response depends on whether SD occurs within the shortest treatment interval. 

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However, sometimes the first evaluation is CR, but scans at subsequent time points show that small lesions seem 
to still appear, so the subject's efficacy at the first time point should actually be PR rather than CR. In this case, 
the first CR judgment should be revised to PR, and the best response is PR. 
1. Best Relief Assessment 
The best response assessment refers to the smallest measurement recorded from the start of 
treatment until disease progression/recurrence (the smallest measurement serves as a guide for 
progression). Discontinuation of treatment due to systemic deterioration, even in the absence of 
PD, should be considered "symptomatic worsening," and detailed documentation of objective 
tumor progression should be obtained after discontinuation of treatment. Patients with early 
progression, early death, and those who cannot be evaluated should be identified. In some cases, it 
may be difficult to distinguish residual tumor lesions from normal tissue. When a complete 
response is assessed based on these circumstances, examination of residual lesions ( fine needle 
aspiration / biopsy ) is recommended to confirm the complete response . When residual imaging 
abnormalities are thought to be fibrosis or scarring , FDG PET can be used to 
confirm CR , similar to biopsy . 
2. Frequency of tumor re-evaluation 
The frequency of tumor reassessment depends on the treatment regimen. In reality, the 
duration of treatment benefit is unclear. Reassessment every two cycles (6-8 weeks) is reasonable, 
but shorter or longer intervals may be adjusted in special circumstances. The need for tumor 
reassessment after treatment is determined by the clinical study endpoint, whether it is response 
rate or time to event (TTE), also known as time to progression/death (TTP/TTD). If TTP/TTD is 
the endpoint, regular repeat assessments are required; there is no strict standard for the interval 
between reassessments. 
3. Confirm 
The goal of objective efficacy confirmation is to avoid overestimating the RR. Changes in 
tumor measurements for CR and PR must be repeatedly assessed and confirmed, with 
reconfirmation required at least 4 weeks after the initial evaluation. Longer confirmation times, as 
determined by the trial protocol, are also appropriate. Patients with SD should have at least one 
lesion measurement demonstrating SD at least 6-8 weeks after treatment. Clinical studies using 
progression-free survival (PFS) and overall survival (OS) as endpoints do not require repeated 
confirmation of changes in tumor size. 
4. Remission period 
It is measured from the time of first CR or PR until the first disease relapse or progression. 
5. Stable period 
It is the time from the start of treatment to disease progression. The correlation between SD 
stage and clinical symptoms varies with different tumor types and different degrees of 

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differentiation. 
The remission period, stable period and PFS are affected by the follow-up frequency after 
baseline evaluation. Due to the influence of multiple factors such as disease type, stage, treatment 
cycle and clinical practice, the basic follow-up frequency has not yet been determined, which to 
some extent affects the accuracy of the trial endpoints. 
IV. Results Report 
All patients, including those who deviated from the treatment plan or were ineligible, were 
assessed for response to treatment (ITT). Each patient was categorized as complete response (CR), 
partial response (PR), sustained death (SD), progressive death (PD), death from cancer, death from 
toxicity, death from other cancers, or unknown (insufficient data for evaluation). All eligible 
patients were included in the risk ratio (RR) analysis, and all PD and death were considered 
treatment failures. Conclusions were based on eligible patients, and further analyses were 
conducted in different patient subgroups, providing 95% confidence intervals. 
 
 

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1 4 .2 Calculation formulas involved in Appendix 2 scheme 
 
Renal function assessment: Cockcroft-Gault formula 
Creatinine is expressed in mg/dL: 
Men: Creatinine clearance (ml/min) = (140-age) × weight / (72 × Scr) 
Women: Creatinine clearance (ml/min) = (140-age) × weight × 0.85 / (72 × Scr) 
Creatinine unit is μmol/L: 
Men: Creatinine clearance (ml/min) = (140-age) × weight / 0.818 × Scr 
Women: Creatinine clearance (ml/min) = (140-age) × weight × 0.85 / 0.818 × Scr 
Note: Scr: serum creatinine (mg/dl) ; age in years; weight in kilograms (kg) 
 
 
Fridericia -corrected QTcF calculation formula: 
QTcF(ms) = QT(ms)/ (RR^0.33) 
Note: ECG does not include RR (RR=60/heart rate) 
 
 
Standard Stevenson formula : 
BSA = 0.0061 × height (cm) + 0.0128 × weight (kg) − 0.1529 
Note: BSA: body surface area. 
 
 

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1 4 .3 Appendix 3 ASTCT CRS and ICANS classifications 
1 4 .3.1 ASTCT CRS classification 
CRS 
parameters 
Level 1 
Level 2 
Level 3 
Level 4 
fever * 
Temperature 
≥38°C 
Temperature 
≥38°C 
Temperature ≥38°C 
Temperature ≥38°C 
and 
low 
blood 
pressure 
none 
No 
boost 
required 
Requires vasopressors with or 
without vasopressin 
Requirement of multiple 
vasopressors 
(excluding 
vasopressin) 
and/or † 
Hypoxia 
none 
Low-flow 
nasal cannula 
oxygen 
required ‡ 
Requires 
high-flow 
nasal 
cannula oxygen ‡ , face mask, 
non-rebreather mask, or Venturi 
mask 
Requirement for positive 
pressure ventilation (eg, 
CPAP, BiPAP, intubation, 
and 
mechanical 
ventilation) 
Note: Organ toxicities associated with CRS can be graded according to CTCAE 5.0, but they do not affect the 
CRS grade. 
*: Fever is defined as a temperature ≥ 38°C not attributable to any other cause. In patients who have had 
CRS and subsequently received antipyretic or anticytokine therapy, such as tocilizumab or steroids, fever is no 
longer required to grade the severity of subsequent CRS. In this setting, CRS grade is due to hypotension and/or 
hypoxia. 
†: CRS grade is determined by the more severe event: hypotension or hypoxia not attributable to any other 
cause. For example, a patient with a temperature of 39.5°C, hypotension requiring 1 vasopressor, and hypoxia 
requiring a low-flow nasal cannula is classified as Grade 3 CRS. 
‡: Low-flow nasal cannula is defined as oxygen delivered at a rate of ≤6 L/min. Low flow also includes 
insufflation oxygen, which is sometimes used in pediatrics. High-flow nasal cannula is defined as oxygen 
delivered at a rate of >6 L/min. 
Reference: Lee DW et al. / Biol Blood Marrow Transplant 25 (2019) 625-638. 
 
 

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1 4 .3.2 ASTCT ICANS classification 
Neurotoxicity 
Level 1 
Level 2 
Level 3 
Level 4 
ICE score * 
7~9 
3~6 
0~2 
0 
(patient 
cannot 
be 
awakened) 
Low 
level 
of 
consciousness † 
spontaneous 
awakening 
Awakened 
by sound 
Awakens only to tactile 
stimulation 
The patient cannot be aroused 
or requires strong or repeated 
tactile stimulation to arouse; 
coma or stupor 
epileptic 
seizures 
not 
applicable 
not 
applicable 
Any clinically focal or 
generalized 
seizure, 
nonconvulsive seizure that 
resolves rapidly on EEG or 
with intervention 
Life-threatening, 
prolonged 
seizures 
(> 
5 
minutes), 
repetitive clinical or electrical 
seizures, without recovery to 
baseline 
Exercise Results 
‡ 
not 
applicable 
not 
applicable 
not applicable 
Deep focal motor weakness, 
such 
as 
hemiparesis 
or 
paraparesis 
Increased 
intracranial 
pressure/cerebral 
edema 
not 
applicable 
not 
applicable 
regional 
edema 
on 
neuroimaging§ 
Diffuse 
cerebral 
edema, 
decerebrate rigidity, cranial 
nerve VI palsy, papilledema, 
or 
Cushing's 
triad 
on 
neuroimaging 
Note: The ICANS rating is determined by the most severe incident that cannot be attributed to any other cause.  
*: A patient with an ICE score of 0 may be classified as a Grade 3 ICANS if they have global aphasia when 
awake, but may be classified as a Grade 4 ICANS if they cannot be aroused. 
†: Not attributable to other causes (e.g., absence of sedative medication). 
‡ Tremor and myoclonus associated with immune effector cell therapy can be graded according to the 
CTCAE 5.0 scale, but they do not affect the ICANS grade. 
§: Intracranial hemorrhage with or without edema is not considered a neurotoxic feature and is not included 
in the ICANS classification. It can be graded according to the CTCAE 5.0 scale. 
ASTCT, American Society for Transplantation and Cellular Therapy; CTCAE, Common Terminology 
Criteria for Adverse Events; EEG, electroencephalogram; ICANS, immune effector cell-associated neurotoxicity 
syndrome; ICE, effector cell-associated encephalopathy; ICP, intracranial pressure. 
 
 

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1 4 .4 Appendix 4 ECOG Performance Status Score 
Grading 
Physical condition 
Level 0 
The ability to move is completely normal, with no difference from the ability to move before 
the onset of the disease. 
Level 1 
Able to move around freely and engage in light physical activities, including general 
housework or office work, but not able to engage in heavy physical activities. 
Level 2 
Able to move around freely and take care of themselves, but have lost the ability to work and 
can be out of bed and active for at least half of the day. 
Level 3 
He can only partially take care of himself and spends more than half of the day in bed or in a 
wheelchair. 
Level 4 
Bedridden and unable to take care of himself . 
Level 5 
die 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1 4 .5 Appendix 5 Possible risks and treatment measures 
The risks associated with lympholysis pretreatment mainly include cytopenia and infection. 
For treatment measures, please refer to IMC002 Treatment measures for cytopenia and 
infection. 
IMC002Possible risks and treatment measures 
Possible risks 
Treatment measures 
Immune 
effector 
cell-
associated hematotoxicity 
(ICAHT) 
• 
The risk of immune effector cell-associated hematologic toxicity 
(ICAHT) was assessed according to the CAR-HEMATOTOX scoring 
table in the CSCO Guidelines for CAR-T Cell Therapy for 
Hematologic Malignancies. 
• 
Administer concentrated red blood cell/platelet transfusions based on 
the subject's risk profile (pay attention to irradiation of blood 
products). 
• 
Subjects with high-risk features for ICAHT received prophylactic G-
CSF (starting on day +2). 
• 
Severe neutropenia (ANC < 500/ul) with or without infection should 
be treated with G-CSF. 
Cytokine 
release 
syndrome (CRS) 
Level 1 CRS processing 
 
Symptomatic supportive treatment ( antipyretic, fluid replacement, 
etc. ) . 
 
Exclude infection (if the patient also has agranulocytosis, give 
prophylactic antibiotics, use G-CSF, and contraindicate GM-CSF). 
 
If the fever persists ( > 3 days) or is refractory , tocilizumab ( 8 mg/kg ) 
can be given . If the symptoms do not improve, it can be repeated after 
8 hours. It is recommended not to exceed 3 times. If CRS does not 
improve after 24 hours of treatment, dexamethasone 5-10 mg qd can 
be given or upgraded to level 2 treatment. 
Level 2 CRS processing 
 
Symptomatic supportive treatment, low-flow oxygen inhalation, and 
anti-infection. 
 
If tocilizumab has not been used, tocilizumab can be given, using the 
same instructions as in level 1. 
 
For patients who are unresponsive to tocilizumab, dexamethasone 10 
mg every 12 hours or once a day for 1-3 days should be administered, 
and the dose should be reduced as soon as symptoms improve. 
 
There was no improvement after 24 hours of dexamethasone treatment 
and the patient was treated according to level 3. 
3-level CRS processing 
 
Consider transfer to the ICU for treatment.  
 
Symptomatic supportive treatment, high-flow oxygen inhalation, 
pressor drugs, and strong anti-infection drugs.  
 
If tocilizumab has not been used, tocilizumab can be given, using the 
same instructions as in level 1. 
 
Dexamethasone 10-20 mg every 6 hours for 1-3 days; reduce the dose 
as soon as symptoms improve. 
4-level CRS processing 
 
Transferred to the ICU, mechanical ventilation, and multiple drugs to 
increase blood pressure . 
 
Symptomatic supportive treatment, potent anti-infection, and 
tocilizumab treatment are the same as those for level 3.  
 
High-dose glucocorticoid therapy is used until symptoms are relieved 
to grade 1, after which the dose can be reduced, such as 
methylprednisolone 1 g/d for 3 consecutive days, followed by 250 mg 

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every 12 hours for 2 consecutive days, 125 mg every 12 hours for 2 
consecutive days, and 60 mg every 12 hours for 2 consecutive days. 
Immune Effector Cell-
Associated Neurotoxicity 
Syndrome (ICANS) 
Level 1 ICANS processing 
 
Without concurrent CRS: Strengthen symptomatic supportive 
treatment . 
 
Concurrent CRS: Tocilizumab can be given , with the same usage as 
CRS . 
 
If swallowing function is affected, oral medications and nutrition 
should be changed to intravenous infusion. 
 
Please consult the neurology department and perform examinations 
such as ophthalmoscopy, cranial imaging, lumbar puncture, and 
electroencephalogram. 
 
If it is assessed that the subject may subsequently develop severe 
neurotoxicity, 5-10 mg of dexamethasone and levetiracetam may be 
administered to prevent epileptic seizures. 
Level 2 ICANS Processing 
 
Symptomatic treatment and corresponding examinations are the same 
as those for level 1. 
 
Patients without CRS or with ineffective anti-IL6 treatment were 
given dexamethasone (10 mg/kg, Every 6 to 12 hours) or 
methylprednisolone equivalent (1 mg/kg, once every 12 hours) , and 
quickly reduce the dose after it drops to level 1 . 
 
Patients with CRS were treated with tocilizumab, with the same usage 
as level 1. 
 
Patients with CRS grade ≥2 are recommended to be transferred to 
the ICU. 
Level 3 ICANS Processing 
 
Symptomatic treatment and examination are the same as those for 
level 1. 
 
It is recommended to transfer to the ICU . 
 
Patients with CRS can be treated with tocilizumab, with the same 
usage as level 1. 
 
Dexamethasone 20 mg q6h was administered until symptoms 
improved to grade 1, after which the dose was rapidly reduced. 
 
Repeat imaging studies every 2–3 days . 
Level 4 ICANS Processing 
 
Symptomatic treatment and examination are the same as those for 
level 1. 
 
Transferred to the ICU and mechanically ventilated . 
 
The principles of anti-IL6 treatment and imaging examinations are the 
same as those for level 3. 
 
High-dose glucocorticoid therapy is used until symptoms are relieved 
to grade 1, after which the dose can be reduced, such as 
methylprednisolone 1 g/d for 3 consecutive days, followed by 250 mg 
every 12 hours for 2 consecutive days, 125 mg every 12 hours for 2 
consecutive days, and 60 mg every 12 hours for 2 consecutive days . 
 
If there is no response to corticosteroids, consider anakinra (an IL-1 
receptor antagonist) . 

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Tumor lysis syndrome 
(TLS) 
 
Provide adequate intravenous hydration.  
 
Allopurinol or febuxostat is given to lower serum uric acid.  
 
Sodium bicarbonate is given intravenously to alkalinize the urine. 
 
Closely monitor electrolytes and renal function, and actively correct 
electrolyte imbalances. 
Immune 
effector 
cell-
associated 
hemophagocytic 
lymphohistiocytosis-like 
syndrome (IEC-HS) 
First-line treatment 
 
Anakinra (adults: 200-800 mg/day) and/or corticosteroids (adults: 
dexamethasone 10-40 mg/day or methylprednisolone 1000 mg/day). 
Second-line treatment 
 
If remission is not achieved after 48 hours, the dose of first-line 
treatment is increased and dual therapy (anakinra + corticosteroids) is 
used. A JAK-2 inhibitor (such as ruxolitinib 5-10 mg/day) may be 
considered. 
Third-line treatment 
 
In addition to JAK-2 inhibitors, gamma interferon monoclonal 
monomers (Imazol), CTLA-4 agonists (such as abatacept), and CD52 
antibodies (alemtuzumab) can be considered. 
 
Etoposide is effective in both pHLH and sHLH, with a preferred dose 
of 50-100 mg/ m 2 
 
In rapidly progressive/life-threatening high-grade IEC-HS, TKIs (eg, 
dasatinib) may be considered as a third-line treatment option after 
failure of first- and second-line therapy. 
 
CAR-T 
associated 
coagulation 
disorder 
(CARAC) 
 
Regularly monitor blood routine and coagulation indicators to detect 
abnormal coagulation function in time. 
 
The main treatment measures include platelet and coagulation factor 
supplementation, appropriate use of anticoagulant or antifibrinolytic 
drugs, etc. 
 
Patients with APTT values >1.5 times the upper limit of normal should 
receive fresh frozen plasma. 
 
When blood fibrinogen is <1.0 g/L, transfuse blood products such as 
cryoprecipitate and/or fibrinogen. 
Hypogammaglobulinemia 
 
Supplement 
immunoglobulin 
therapy 
to 
restore 
serum 
immunoglobulin levels to normal levels. The researcher will refer to 
the treatment plan and make appropriate arrangements based on the 
patient's condition . 
 
Infect 
   Any level 
 
Prophylactic antiviral and Pneumocystis jiroveci pneumonia treatment 
until 6–12 months after CAR-T cell infusion and/or CD4 cell count > 
200 cells/μl . 
 
Antifungal drugs should be considered in high-risk patients. 
 
G-CSF is recommended for patients with persistent neutropenia for >7 
days after CRS . 
Level 1 
 
Provide supportive care. 
 
If fever occurs, empirical anti-infective treatment is recommended. 
Level 2 
 
Start oral antibiotics according to the course of treatment. 
Level 3 
 
Intravenous antibiotics were started. 
Level 4 
 
Intensive care supportive treatment . 
 
Allergic reaction 
 
Use anti-allergy drugs prophylactically . 
 
Treat the symptoms. When a severe allergic reaction occurs, 

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researchers should immediately provide emergency treatment 
according to relevant diagnosis and treatment routines. 
 
Abnormal proliferation of 
CAR-T cells 
 
Glucocorticoids and other immunosuppressants (eg, antithymocyte 
globulin or anti-CD52 antibodies) . 
 
Severe patients may use two or more immunosuppressants. 
Acute gastric mucosal 
injury/gastrointestinal 
bleeding 
According to the severity of the disease and the risk of death, patients are 
divided into dangerous acute gastric mucosal lesion (AGML) patients and non-
risk AGML patients. Patients with AGML accompanied by high-risk underlying 
diseases or severe gastrointestinal bleeding (including AGML patients with 
abnormal coagulation mechanism and difficult to stop bleeding) or even 
perforation are classified as dangerous AGML patients, otherwise they are non-
risk AGML patients. 
 
In this clinical study, strict inclusion and exclusion criteria must be adhered 
to, excluding patients at high risk for gastrointestinal bleeding. Prophylactic 
use of proton pump inhibitors and gastric mucosal protective agents can be 
administered during the three days before cell infusion and the four-week 
intensive observation period after cell infusion. Gastric protection, 
antiemetics, and nutritional support can also be administered as appropriate. 
Before and after cell infusion, fecal occult blood, routine blood tests, 
coagulation function, cytokines, CAR copy number, and imaging studies 
should be closely monitored. For patients with a higher risk of bleeding due 
to the primary tumor site, changes after tumor treatment should be closely 
monitored. Drugs that may damage the gastric mucosa and increase the 
incidence of gastrointestinal bleeding should be avoided. 
 
Treatment principles for dangerous AGML and non-dangerous AGML: The 
main "risks" of dangerous AGML come from, on the one hand, large blood 
loss or difficult-to-control gastrointestinal bleeding, secondary hemorrhagic 
shock, multiple organ dysfunction and failure; on the other hand, they also 
come from gastrointestinal perforation and bacterial translocation that occur 
in dangerous AGML, which lead to disease progression and multiple organ 
dysfunction and failure. The focus of early treatment is on emergency organ 
function assessment and emergency organ function resuscitation and 
support. Only in the later stage will AGML be treated in a targeted manner. 
The treatment principles for non-dangerous AGML are, first, to inhibit 
factors that damage the gastric mucosa, such as inhibiting gastric acid and 
increasing the pH value in the stomach; second, to strengthen the protective 
mechanism of the gastric mucosa; and third, to adjust the coagulation 
function to prevent worsening of gastrointestinal bleeding. 
 
When acute gastric mucosal injury or gastrointestinal bleeding occurs, it is 

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recommended to refer to the "Chinese Expert Consensus on Emergency 
Treatment of Acute Gastric Mucosal Lesions", "Guidelines for the 
Diagnosis and Treatment of Acute Non-varicose Upper Gastrointestinal 
Bleeding", and "Guidelines for the Diagnosis and Treatment of Lower 
Gastrointestinal Bleeding" for treatment according to the condition. If 
necessary, please consult and implement the treatment in collaboration with 
relevant disciplines. 
 
For subjects diagnosed with acute gastrointestinal bleeding, the bleeding 
site, urgency, cause, and volume should be assessed as soon as possible. For 
subjects diagnosed with acute upper gastrointestinal bleeding, active 
treatment should include withholding water, high-dose proton pump 
inhibitors for acid suppression, fluid replacement, infusion, and vasoactive 
medications. The severity and prognosis can be assessed using the GBS or 
Rockall scoring systems. Signs of bleeding should also be closely 
monitored, including recording the frequency, color, nature, frequency, and 
total volume of vomiting, melena, and hematochezia. Red blood cell (RBC), 
hemoglobin, hematocrit, and blood urea nitrogen should be regularly 
checked, and vital signs and circulatory status should be monitored. For 
subjects unresponsive to medical treatment, endoscopic hemostasis should 
be initiated as soon as possible, and surgery or interventional embolization 
may be necessary if necessary. For subjects diagnosed with lower 
gastrointestinal bleeding, the basic principles of management include rapid 
assessment, hemodynamic stabilization, localization and qualitative 
diagnosis, and treatment as needed. Treatment options include supportive 
care, medical therapy, endoscopic therapy, vascular embolization, and 
surgical intervention. 
When grade 3 to 4 gastrointestinal bleeding occurs, the researcher should 
decide whether to suspend or stop the trial drug based on the patient's condition. 
 
 
 
 
 
 
 
 
 
 
 

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Possible risks and treatment measures of important adverse reactions of apatinib mesylate 
 
Possible risks 
Treatment measures 
hypertension 
Blood pressure should be monitored regularly during medication. If necessary, 
antihypertensive treatment or dosage adjustment should be initiated under the guidance of a 
specialist. If Grade 3/4 blood pressure elevation occurs, medication suspension/dose 
adjustment or discontinuation is recommended, depending on the specific circumstances. 
For patients experiencing hypertensive crisis, this product should be discontinued during this 
period. 
proteinuria 
Patients are advised to have their urine routine and renal function checked regularly during 
medication. Seek medical attention promptly if proteinuria occurs. If grade 2 or higher 
proteinuria occurs, medication should be suspended. If necessary, the dosage should be 
adjusted or the medication should be discontinued based on the specific circumstances. 
Bleeding 
Prothrombin time and international normalized ratio should be closely monitored during 
medication. Once severe (grade 3/4) abnormalities occur, consideration should be given to 
suspending the medication, adjusting the dose, or discontinuing the medication based on the 
specific circumstances. 
Skin toxicity 
If hand-foot syndrome occurs, necessary symptomatic supportive treatment can be taken 
under the guidance of a physician. If hand-foot syndrome of grade 2 or higher occurs three 
times in a row and worsens, it is recommended to suspend medication; if necessary, adjust 
the dose or discontinue the medication. 
Hepatotoxicity When patients experience grade 3/4 elevation of transaminase or total bilirubin, it is 
recommended to suspend medication and monitor serum transaminase and total bilirubin 
until their levels drop significantly before resuming medication. If the adverse reaction 
reappears after resuming medication or persists, it is recommended to stop the medication. 
Cardiotoxicity 
Close monitoring of electrocardiogram (ECG) and cardiac function should be performed 
during medication. If a grade 3/4 adverse reaction occurs, medication suspension is 
recommended. If the adverse reaction recurs after resumption or persists, dose adjustment 
or drug discontinuation is recommended based on the specific circumstances. 
Discontinuation of medication is recommended for patients with grade III-IV heart failure 
or a left ventricular ejection fraction <50% as determined by cardiac ultrasound. 
 
Possible risks and treatment measures of important adverse reactions of paclitaxel 
Possible risks 
Treatment measures 
Myelosuppression The complete blood count should be closely monitored during medication, and 
symptomatic supportive treatment should be taken in a timely manner according to the 
degree of bone marrow suppression. 
Allergic reaction 
All patients should receive pre-treatment with corticosteroids (such as dexamethasone), 
diphenhydramine, and an H2 receptor antagonist (such as cimetidine or ranitidine) before 
paclitaxel treatment, and undergo ongoing safety monitoring, including the occasional 
occurrence of chills, shock, and back pain associated with allergic reactions. 
Cardiovascular 
toxicity 
Vital sign monitoring is recommended during paclitaxel treatment, especially within one 
hour of paclitaxel infusion. 
 
 

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Possible risks and treatment measures of important adverse reactions of docetaxel 
 
Possible risks 
Treatment measures 
Hematological 
toxicity 
neutrophil counts <1500 cells/mm³ . Frequent blood counts should be performed in all 
patients receiving docetaxel to monitor for the development of neutropenia and prevent it 
from developing into a severe infection. Dosage adjustments should be made according to 
the labeling. 
Allergic 
reaction 
Equipment for treating hypotension and bronchospasm should be readily available. Close 
monitoring of key functional indicators is recommended during medication use. Unless 
contraindicated, patients should receive prophylactic medication prior to docetaxel 
treatment. 
Hepatotoxicity 
Docetaxel should be avoided in patients with bilirubin levels above the upper limit of the 
recommended daily limit (ULN) or AST and/or ALT levels >1.5×ULN combined with 
alkaline phosphatase levels >2.5×ULN. Patients with elevated bilirubin or abnormal 
transaminases with elevated alkaline phosphatase are at increased risk for grade 4 
neutropenia, febrile neutropenia, infection, severe thrombocytopenia, severe gastritis, 
severe skin toxicity, and toxic mortality. Therefore, bilirubin, AST or ALT, and alkaline 
phosphatase should be measured before starting docetaxel each cycle. 
Gastrointestinal 
reactions 
Particular caution should be exercised in patients with neutropenia, particularly those at risk 
for gastrointestinal complications. Enterocolitis can occur at any time and can be fatal 
within the first day of illness. Patients should be closely monitored for early clinical 
manifestations of severe gastrointestinal toxicity. 
Fluid retention 
Unless contraindicated, patients should receive prophylaxis before docetaxel treatment to 
reduce the incidence and severity of fluid retention and to reduce the severity of allergic 
reactions. 
Skin 
and 
subcutaneous 
tissue diseases 
Patients should be informed of the signs and symptoms of severe skin manifestations and 
monitored closely. If adverse skin reactions are observed, discontinuation of treatment 
should be considered. 
 
Possible risks and treatment measures of important adverse reactions of irinotecan 
hydrochloride injection 
Possible risks 
Treatment measures 
Contraindications 
It is contraindicated in patients with chronic inflammatory bowel disease and/or 
intestinal obstruction, bilirubin exceeding 3 times the upper limit of normal value; 
severe bone marrow suppression: patients with WHO performance status score greater 
than 2 points. 
diarrhea 
65 years or older are more likely to develop early-onset diarrhea and should be 
monitored more closely. Late-onset diarrhea may last longer and may lead to 
dehydration, electrolyte imbalance, or infection, and may even be fatal. If late-onset 
diarrhea occurs, prompt treatment with Imodium is necessary. Patients should be 
instructed to have Imodium available and to start treatment with Imodium if they 
experience unformed or loose stools or increased bowel movement frequency. 
Prophylactic administration of Imodium is not recommended. Patients with diarrhea 
must be closely monitored. If dehydration occurs, water and electrolytes should be 
supplemented. If intestinal obstruction, fever, or severe neutropenia occurs, antibiotics 
should be administered. Medication should be suspended, dosage adjusted, and 
hospitalization may be necessary depending on the specific situation. 
Hematologic 
toxicity 
If febrile neutropenia occurs or the absolute neutrophil count falls below 1.5 × 10 9 
/L, irinotecan hydrochloride chemotherapy should be suspended. A new course of 
chemotherapy should be initiated after the granulocyte count returns to >1.5 × 10 9 
/L. After the patient recovers, the subsequent irinotecan hydrochloride dose should be 
reduced based on the patient's neutropenia. Routine administration of colony-
stimulating factor (CSF) is not required, but physicians may consider administering 
CSF to patients with neutropenia. 

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Hepatotoxicity 
Patients should undergo regular laboratory evaluation of liver function. 
Immunosuppressant 
effects / increased 
susceptibility 
to 
infection 
Administration of live or live-attenuated vaccines to patients who are 
immunocompromised due to chemotherapy, including irinotecan hydrochloride, may 
result in serious or fatal infections. Live vaccines should be avoided in patients taking 
irinotecan hydrochloride. Killed or inactivated vaccines are acceptable, but their 
effectiveness may be reduced. 

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14.6 Appendix 6 Central Laboratory Information 
Central Laboratory 1: Tissue section - Claudin 18.2 detection; Whole blood - CAR copy number, 
CAR-T cell subsets/phenotype, immunogenicity detection, RCL detection, lentiviral genome 
insertion site; Serum - cytokines 
Name of testing and analysis unit: Guorui Yikang Medical Laboratory (Shanghai) Co., Ltd. 
Unified social credit code: 91310118MA1JL5119D 
Address: 2nd and 3rd Floor, Block B, 14th Building, South District, E-Tong World, No. 685, Huaxu 
Road, Xujing Town, Qingpu District, Shanghai 
Name of the remaining sample processing unit: Shanghai Solid Waste Disposal Co., Ltd. 
Unified Social Credit Code: 913101147294906145 
Address: No. 2491, Jiazhu Road, Jiading District, Shanghai 
 
Central Laboratory II: Serum-Infectious Disease Testing (HBsAg, HBsAb, HBeAg, HBcAb, 
HBeAb, HCV Antibody, Syphilis Antibody, HIV Antibody, HBV-DNA, HCV-RNA, EBV IgM 
Antibody, CMV IgM Antibody, HTLV Antibody, SARS-CoV-2 Antibody (IgM)) 
Name of testing and analysis unit: Wuxi Guanhe Medical Laboratory Co., Ltd. 
Unified Social Credit Code: 91320214MA20PUKD2P 
Address: 1st and 5th Floor, Building A, Xingye Building, No. 99 Linghu Avenue, Xinwu District, 
Wuxi City, Jiangsu Province 
Name of the remaining sample processing unit: Hangzhou Dadi Weikang Medical Environmental 
Protection Co., Ltd. 
Unified Social Credit Code: 913301057544069124 
Address: Room 325, Building 2, No. 28, Xiangyuan Road, Gongshu District, Hangzhou, Zhejiang 
Province