Actively Recruiting
A Clinical Research About 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
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic Gynecologic Cancer, and obtain recommended doses and infusion patterns.
CONDITIONS
Official 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
- Advanced or metastatic gynecologic tumor confirmed by histopathology or cytology with CD70 positive tumor expression (IHC 3+)
- Disease progression or intolerance after standard treatments with no effective options currently
- At least one measurable target lesion by RECIST 1.1 criteria
- ECOG performance status between 0 and 2
- Expected survival time longer than 12 weeks
- No serious mental disorders
- Adequate function of important organs including hematopoietic, cardiac, renal, liver functions, and blood oxygen saturation above 92%
- Eligibility for blood collection without contraindications
- Agreement to use reliable contraception for one year from consent to CAR T cell infusion
- Willingness to participate and signed informed consent
You will not qualify if you...
- Prior anti-CD70 drug therapy
- Active or symptomatic central nervous system or meningeal metastases at screening
- Participation in other interventional clinical studies or recent use of unmarketed or marketed drugs within specified washout periods
- Recent chemotherapy, targeted therapy, radiation, or systemic corticosteroid therapy above specified thresholds
- Live attenuated vaccine within 4 weeks prior to screening
- Active or uncontrolled infection requiring systemic treatment within 1 week prior to screening
- Other malignancies within 3 years except adequately treated non-melanoma skin cancer
- Serious heart conditions including advanced heart failure, recent myocardial infarction or coronary surgery, significant arrhythmias, or severe cardiomyopathy
- Active or uncontrolled autoimmune diseases
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus beyond normal ranges
- History of venous embolism needing anticoagulants or significant ongoing complications
- Poorly controlled hypertension despite treatment
- Pregnancy or breastfeeding, or plans for family within 1 year after CAR T cell transfusion
- Other conditions judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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