Clinical trial NCT06703398: A Multicenter, Randomized, Controlled,Open Label, Phase II Trial of Autologous Tumor Infiltrating Lymphocytes (GC101 TIL) in Subjects With Advanced Melanoma
Official title: A Multicenter, Randomized, Controlled,Open Label, Phase II Trial of Autologous Tumor Infiltrating Lymphocytes (GC101 TIL) in Subjects With Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Melanoma
Keywords: Randomized-controlled trial
Tumor Infiltrating Lymphocytes
Chemotherapy
Lead sponsor: Shanghai Juncell Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-11-25
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial，this trail is expected to be finished in 24 months

Detailed description: This study is to investigate the efficacy and safety of autologous tumor infiltrating lymphocyte (GC101 TIL) therapy versus investigator's choice of chemotherapy in patients with advanced melanoma. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with cyclophosphamide and hydroxychloroquine.

Eligibility criteria: Inclusion Criteria:

* Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
* Aged ≥18 years and ≤75 years, regardless of gender;
* Patients with unresectable advanced, recurrent or metastatic melanoma (excluding uveal melanoma) ;
* Patients who have failed or resisted to PD-1 antibodies；
* TILs can be isolated from a surgically resectable tumor region: the tissue volume must be \>150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;There are still at least 1 measurable lesion (according to RECIST1.1 criteria \[see Appendix 4\]) even after TIL sampling and resection of surgically resectable tissue;
* ECOG performance status 0-1;
* Expected survival time \>3 months;
* With sufficient hematology and end-organ function;
* Good compliance and able to adhere to the study visit plan and other agreement requirements.

Exclusion Criteria:

* Participation in a clinical trial of another drug or biologic therapy or receipt of a comparable cellular therapy within 28 days prior to screening;
* Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer or malignant nevus of freckle-like nevus without evidence of disease recurrence; adequately treated carcinoma in situ without evidence of disease recurrence;
* Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;
* Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, etc., which in the judgment of the investigator pose no safety risk);
* Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation;
* Uncontrolled co-morbidities including, but not limited to, uncontrolled arterial hypertension (systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥100 mmhg) even with standardized treatment or any unstable cardiovascular disease including transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina pectoris within 6 months prior to enrollment; new york heart association ( nyha class iii or iv congestive heart failure with an ejection fraction \<50%; or severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree ii-iii atrioventricular block, etc., requiring clinical intervention; ecg results showing clinically significant abnormalities or a qtcf ≥450ms (if the first test is abnormal, it may be retested at least 5 minutes apart twice and the combined result/mean value to determine eligibility) ;
* Patients with esophageal or gastric varices that require immediate intervention (e.g., taping or sclerotherapy) or are considered to be at high risk for bleeding based on the opinion of the investigator or consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegaly detected on imaging), or have a prior history of variceal bleeding must have undergone endoscopic evaluation within 3 months prior to enrollment;
* Uncontrolled metabolic disorders, such as diabetes mellitus known to be uncontrolled, or other non-malignant organ or systemic diseases or secondary reactions to cancer, and which can lead to higher medical risk and/or uncertainty in survival evaluation;
* Hepatic encephalopathy, hepatorenal syndrome or child-pugh class b or more severe cirrhosis, liver failure;

Primary outcomes:
measure: Progression-free survival
timeFrame: Every 6 weeks for 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: Maximum 2 years
measure: Progression-free survival
timeFrame: Every 6 weeks for 12 months
measure: Objective Response Rate
timeFrame: Maximum 360 days
measure: Disease Control Rates
timeFrame: Every 6 weeks for 12 months
measure: Duration of Response
timeFrame: Every 6 weeks for 12 months
measure: Adverse Events
timeFrame: Maximum 360 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
References: