Actively Recruiting
A Single-arm, Open, Exploratory Clinical Study of Allogeneic CAR-T Cells in the Treatment of Relapsed/Refractory Brain Gliomas With Positive CD70 Expression
Led by JIANG LONGWEI · Updated on 2025-02-14
3
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
J
JIANG LONGWEI
Lead Sponsor
N
Nanjing Kanghe Cell Gene Engineering Research Institute Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if allogeneic CAR-T cells can treat patients with advanced gliomas. The main questions it aims to answer are: Evaluate the safety of allogeneic CAR-T cells in the treatment of advanced gliomas. To evaluate the effectiveness of allogeneic CAR-T cells in the treatment of advanced gliomas and to study its immunological properties in patients.
CONDITIONS
Official Title
A Single-arm, Open, Exploratory Clinical Study of Allogeneic CAR-T Cells in the Treatment of Relapsed/Refractory Brain Gliomas With Positive CD70 Expression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to follow the study treatment and visit plan, voluntarily enroll, and sign informed consent
- Aged 18 years or older at consent
- Have recurrent or refractory glioma with confirmed CD70 positive expression by cytology or histology
- CD70 expression in tumor site meets positive standard (≥2+ by immunohistochemistry), tested within 2 years
- Have at least one measurable lesion according to RANO criteria
- Expected survival of at least 12 weeks
- Kanofsky performance score of 70 or higher
- Adequate organ and bone marrow function as defined by specific blood counts and liver, kidney, and coagulation test limits
- Fully recovered from previous treatment toxicity to Grade 1 or below except for certain conditions
- Fertile participants must use effective contraception from consent until 6 months after CAR-T and have negative pregnancy test before dosing
You will not qualify if you...
- Received any CD70-targeted treatment within 3 years
- Used experimental drugs or devices within 28 days before CAR-T
- Received systemic anti-tumor treatment within 28 days or 5 half-lives before CAR-T
- Had radiotherapy within 3 months before CAR-T
- Used other non-CD70 cell therapy products within 2 months before CAR-T
- Positive for replication-competent lentivirus after prior cell therapy
- Used therapeutic doses of glucocorticoids within 14 days before CAR-T
- Used anticoagulants within 7 days before CAR-T
- Have other active or recent malignant tumors except certain cured cancers
- History of allogeneic organ or stem cell transplantation
- Immunodeficiency, autoimmune diseases, or need for immunosuppressants
- Received live vaccines within 14 days before screening or during study
- Severe or uncontrolled systemic disease or unstable conditions
- Known severe cardiovascular disease or abnormal heart function
- Positive tests for certain infections including HIV, CMV, EBV, hepatitis B or C
- Pregnant or breastfeeding women
- Other conditions affecting compliance or suitability as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanjing Jinling Hospital
China, Jiangsu, China, 210002
Actively Recruiting
Research Team
J
Jiang Longwei, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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