Actively Recruiting
A Phase I Clinical Study of CD70-targeting CAR-T Therapy in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
Led by Weijia Fang, MD · Updated on 2025-05-31
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Weijia Fang, MD
Lead Sponsor
C
Chongqing Precision Biotech Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a new CAR-T cell therapy targeting CD70 in patients with advanced or metastatic solid tumors that express CD70. This phase I study aims to find the highest dose patients can safely receive and to recommend a dose for future studies. The trial focuses on patients who have not responded to or cannot tolerate standard treatments and have measurable tumors. The study has two groups receiving CD70-targeted CAR-T cells either by intravenous infusion or intraperitoneal injection. Each group includes three dose levels using a dose-escalation design called 3+3, with about nine patients planned for each group. Before receiving the CAR-T cells, patients are treated with Fludarabine and Cyclophosphamide. This is an open-label trial without randomization or masking. Participants will be closely monitored for adverse events and dose tolerance during the first 28 days after infusion. Researchers will also assess disease control, objective response rates, treatment duration, and pharmacodynamics over three months. Evaluations include imaging scans, blood tests, and clinical assessments. The total study duration includes safety monitoring, with ongoing follow-up to understand the therapy’s effects and safety profile.
CONDITIONS
Brief Title
A Clinical Study of 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
- Diagnosed with advanced or metastatic solid tumor with positive tumor CD70 expression confirmed by pathology
- Disease progression or intolerance after standard treatments like surgery, chemotherapy, or radiotherapy, with no current effective treatment
- At least one measurable target lesion according to RECIST 1.1 criteria
- ECOG performance status between 0 and 2
- Expected survival time of more than 12 weeks
- No serious mental disorder
- Normal important organ functions including hematopoietic, cardiac, renal, and liver functions
- Oxygen saturation greater than 92% without oxygen support
- Eligible for apheresis or venous blood collection without contraindications
- Agree to use effective contraception methods for 1 year after CAR-T infusion
- Provide informed consent and understand the trial procedures
You will not qualify if you...
- Prior treatment with anti-CD70 drugs before screening
- Active or symptomatic central nervous system or meningeal metastases
- Participation in other interventional clinical studies within 3 months or use of certain drugs within specified times before cell reinfusion
- Recent chemotherapy, targeted therapy, or high-dose corticosteroids before apheresis
- Live attenuated vaccine within 4 weeks before screening
- Active or uncontrolled infections requiring systemic treatment
- Other malignant tumors within 3 years except treated non-melanoma skin cancers or tumors without active disease
- Severe heart conditions including NYHA stage III or IV heart failure, recent myocardial infarction, significant arrhythmia, or severe cardiomyopathy
- Active or uncontrolled autoimmune diseases
- Positive for certain infections including hepatitis B or C, HIV, syphilis, or cytomegalovirus with abnormal lab values
- History of serious venous thromboembolic events requiring ongoing anticoagulation or with lasting symptoms
- Poorly controlled hypertension
- Pregnancy, breastfeeding, or planning pregnancy within 1 year after CAR-T treatment
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 28 days
Participants receive pre-treatment with Fludarabine and Cyclophosphamide followed by infusion of CD70-targeted CAR-T cells either intravenously or via intraperitoneal injection.
1 pre-treatment visit and 1 infusion visit
Duration - Up to 3 months
Participants are monitored for safety, tolerability, and treatment response after CAR-T cell infusion.
Weekly visits for up to 4 weeks followed by monthly visits for 2 months
Trial Site Locations
Total: 1 location
1
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
W
Weijia Fang, 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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