Actively Recruiting
A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-11-08
48
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
T
The First Affiliated Hospital of Nanchang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CD70-targeted CAR-T cells in treating patients with CD70-positive advanced or metastatic solid tumors. This phase 1, single-center study involves two groups based on the delivery method: intravenous infusion and intraperitoneal injection. The study aims to find the recommended doses and infusion patterns for these treatments using a dose-escalation design. Each group undergoes two phases: a dose discovery phase with four dose levels using a 3+3 design to recruit about 12 subjects, followed by a dose expansion phase where one or two dose levels are further tested for safety and efficacy with about 6 subjects per dose group. Before CAR-T cell infusion, patients receive lymphodepletion with fludarabine and cyclophosphamide. The doses range from 1 to 10 million cells per kilogram. During the study, participants will be closely monitored for side effects and treatment responses. Researchers will measure adverse events within 28 days and determine the maximum tolerated dose. Effectiveness outcomes include disease control rate, objective response rate, duration of response, progression-free survival, and overall survival over periods up to two years. The study also evaluates the behavior of CAR-T cells in the body over three months. Participants' organ functions, quality of life, and safety will be regularly assessed throughout the trial.
CONDITIONS
Brief Title
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Confirmed advanced or metastatic solid tumor with positive CD70 expression (IHC 3+) by histology or pathology
- Disease progression or intolerance after TKI/PARPi, anti-vascular drug treatment, or no effective standard treatment available
- Measurable and evaluable lesions defined by RECIST version 1.1, including MRI lesion size criteria
- ECOG performance status of 0 to 2
- Expected survival time greater than 12 weeks
- No serious mental disorder
- Basic normal function of important organs including hematopoietic, cardiac, renal, and liver functions
- Oxygen saturation above 92% without oxygen support
- Suitable for apheresis or venous blood collection without contraindications
- Agreement to use effective contraception for 1 year after CAR-T infusion
- Informed consent signed by participant or guardian
You will not qualify if you...
- Previous treatment with anti-CD70 drugs
- Active or symptomatic central nervous system or meningeal metastases unless stable for at least 4 weeks post-treatment
- Participation in other interventional clinical studies with recent use of unmarketed or marketed drugs within specified timelines
- Recent chemotherapy, targeted therapy, or systemic corticosteroids above 10 mg/day prednisone equivalent before apheresis
- Recent live attenuated vaccine within 4 weeks before screening
- Active or uncontrolled infection requiring systemic treatment within 1 week before screening
- Other malignant tumors within 3 years except treated non-active cancers
- Severe heart diseases including NYHA stage III-IV heart failure, recent myocardial infarction or CABG, significant arrhythmias, or severe cardiomyopathy
- Active or uncontrolled autoimmune diseases
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus above normal ranges
- Recent venous thromboembolic events requiring anticoagulation or severe bleeding sequelae
- Poorly controlled hypertension above 150/90 mmHg unless controlled with treatment
- Pregnancy, breastfeeding, or planning pregnancy within 1 year after CAR-T infusion
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days after CAR-T cell infusion
Participants receive lymphodepletion followed by infusion or injection of CD70-targeted CAR-T cells to treat CD70-positive advanced or metastatic solid tumors.
1 infusion or injection visit and multiple follow-up visits within 28 days
Duration - Up to 2 years
Participants are monitored for safety, disease response, and survival outcomes after treatment with CD70-targeted CAR-T cells.
Regular visits for up to 2 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
F
Fei Li, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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