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 Gynecologic Cancer
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2024-01-22
36
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
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 gynecologic cancers. This Phase 1 study focuses on patients who have not responded to standard treatments and aims to find the best doses and infusion methods for these CAR-T cell therapies. The study has two groups based on how the CAR-T cells are given: one group receives the treatment through intravenous infusion, and the other through intraperitoneal injection. Each group undergoes two phases: a dose discovery phase that uses a dose-escalating design to find recommended doses, followed by a dose expansion phase to further evaluate safety and effectiveness at those doses. Participants receive doses ranging from 1 to 10 million cells per kilogram. Participants will be closely monitored for adverse events and treatment effects over time. Researchers will assess safety outcomes within the first 28 days after infusion and effectiveness outcomes such as disease control and response rates over three months, with longer-term follow-up up to two years. Various lab tests, imaging scans, and clinical evaluations will be done to track how the CAR-T cells behave and impact the cancer. The total study duration and detailed monitoring are designed to ensure participant safety and collect data on how well the CAR-T cells work.
CONDITIONS
Brief Title
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Gynecologic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed advanced or metastatic gynecologic tumor with CD70 positive expression by histology or pathology
- Failure or intolerance to standard treatments with no effective current options
- At least one measurable target lesion per RECIST 1.1 criteria
- ECOG performance status between 0 and 2
- Expected survival time greater than 12 weeks
- No serious mental disorders
- Basic normal function of important organs, including hematopoietic, cardiac, renal, liver, and adequate blood oxygen saturation
- Able to undergo blood collection and no contraindications for cell collection
- Agree to use reliable contraception excluding safe period contraception for one year after treatment
- Willing and able to provide informed consent
You will not qualify if you...
- Prior treatment with anti-CD70 drugs
- Active or symptomatic central nervous system or meningeal metastasis at screening
- Recent participation in other interventional studies or recent anti-tumor therapies including chemotherapy, targeted therapy, or radiation within specified timeframes
- Use of systemic corticosteroids above 10mg/day prednisone equivalent within two weeks before cell collection (with some exceptions)
- Received live attenuated vaccines within 4 weeks before screening
- Active or uncontrolled infections requiring systemic treatment within 1 week before screening
- Other malignancies within 3 years except certain treated skin cancers or cancers without active disease for 3 or more years
- Significant heart conditions including advanced heart failure, recent myocardial infarction, serious arrhythmias, or severe cardiomyopathy
- Active or uncontrolled autoimmune diseases
- Positive tests for certain infections such as hepatitis B or C, HIV, syphilis, or cytomegalovirus with elevated viral loads
- History of venous embolism requiring anticoagulation or persistent complications thereof
- Poorly controlled hypertension despite treatment
- Pregnancy or breastfeeding, or plans to have a family within 1 year post treatment
- Any 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
Participants receive CD70-targeted CAR-T cells after lymphodepletion with Fludarabine and Cyclophosphamide via intravenous infusion or intraperitoneal injection to treat CD70-positive advanced or metastatic gynecologic cancer.
Multiple visits during the 28-day treatment period
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes, including disease control, response rates, and survival over time.
Visits for assessments over 2 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Actively Recruiting
Research Team
G
Guantai Ni, 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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