Clinical trial NCT06682117: A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor
Official title: A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment
Neoantigen
Vaccine
Solid Tumor Cancer
Keywords: advanced solid tumors
DC vaccine
neoantigen
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm, single center, open label study designed as \&#34;3+3\&#34; model to explore the MTD and DLT of personalized self-DC vaccine targeting neoantigen in treatment of advanced solid tumor.
Primary purpose: TREATMENT

Brief summary: This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.

Detailed description: This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors (especially head and neck cancer, non-driver gene sensitive mutation of non-small cell lung cancer). The investigators plan to enroll about 9 patients to explore the dose limited toxicity or recommended dose for future study of Neo-DC vaccine. The study is designed as 3 plus 3 model, and set two dose levels.

Eligibility criteria: Inclusion Criteria:

1. 18-75 years.
2. Histologically or cytologically confirmed advanced solid tumor, with at least one tumor lesion measurable (basis RECIST1.1 standard).
3. HLA typing was HLA-A0201/1101/2402 (containing at least one of the typing, according to the central laboratory issued).
4. Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (for tumors with easy sampling).
5. Before enrollment, systemic standard treatment failure or standard treatment intolerance, and meet the following tumor requirements : new antigen positive（head and neck tumors, non-small cell lung cancer without driver genes (no EGFR sensitive mutation / ALK fusion positive), esophageal squamous cell carcinoma).
6. Voluntary to participate in clinical research ; the person or legal guardian fully understands and is informed of this study and sign the informed consent; willing to follow and be able to complete all test procedures;
7. ECOG score 0-1.
8. Have a venous access to meet single collection or venous blood collection;
9. Expected survival time ≥ 6 months.
10. Subjects were willing to study the use of reliable contraceptive methods during treatment and within 3 months after the end of treatment, and women of childbearing age.
11. Have adequent organ functions.
12. Before administration of Neo-DCV injection : 1) any chemotherapy, targeted drugs, immune checkpoint inhibitors, other clinical trial research drugs, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments received have passed the 4-week elution period, and the toxic and side effects returned to grade 1 or lower (except for alopecia, vitiligo and other tolerable events judged by researchers) ; 2) If undergoing major surgery within 3 weeks, the adverse reactions have returned to grade 1 or lower.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Patients with a history of severe immediate allergies to the cells and any drugs used in this study.
3. Those with a history of organ transplantation.
4. Known central nervous system metastasis.
5. Any active autoimmune disease or any autoimmune disease that has been determined by the researchers to be unsuitable for this study.
6. Uncontrolled concomitant diseases or infectious diseases, such as the need for systemic antibiotics within 2 weeks before enrollment.
7. Suffering from severe liver and kidney function damage (liver, kidney treatment but still not controllable, biochemical indicators can not meet the inclusion criteria of NO.11, or can not control the diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poor drug control of hypertension ( systolic blood pressure more than 160mmHg and/or diastolic blood pressure more than 90mmHg), or with clinical Bed meaning (e.g. activity ) of cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (6 months before signing informed consent) unstable angina, myocardial infarction (within 6 months before signing informed consent), unstable angina, New York Heart Association, or any circumstances which, in the opinion of the researcher, may increase the risk of the subject or interfere with the results of the test.
8. Subjects planned to receive sugar within 4 weeks before the first Neo-DCV injection and during the study period due to certain conditions.

   Corticosteroids (prednisone or the same drug dose less than 10mg/day ) or other immunosuppressive agents were excluded.
9. Subjects were scheduled to receive Neo-DCV injection within 4 weeks before the first administration and during the study period due to certain conditions.
10. The researchers assessed that the subjects were unable or unwilling to comply with the requirements of the study protocol.
11. The defects of antigen presentation, antigen recognition and cell killing related genes were detected by sequencing.
12. There was a history of other malignant tumors in the past 5 years, except for curable basal cell carcinoma, papillary thyroid carcinoma, and uterus.
13. Subjects have any disease or medical condition that may affect the evaluation of the safety or efficacy of the study drug.

Primary outcomes:
measure: Adverse events
timeFrame: Within 28 days after the first Neo-DC vaccine cell infusion
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: up 2 years
measure: Dose limited toxicity
timeFrame: Within 28 days after the first Neo-DC vaccine cell infusion
Other outcomes:
measure: IFN-γ activity detected by ELISPOT, cell factor and T cell subsets detection.
timeFrame: up 2 years
measure: iDCR
timeFrame: up 2 years
measure: iPFS
timeFrame: up 2 years
measure: iDOR
timeFrame: up 2 years
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xianghua Wu, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Qinghai Ji, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Dongmei Ji, M.D
role: PRINCIPAL_INVESTIGATOR
References: