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
103 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
Researchers are studying whether allogeneic CAR-T cells can treat patients with advanced gliomas, a type of brain tumor. This early-phase study focuses on evaluating the safety and effectiveness of these cells, which are designed to target tumors expressing the CD70 protein. The trial aims to better understand how these immune cells work in patients with relapsed or refractory gliomas who have limited treatment options. Participants with confirmed advanced gliomas showing CD70 expression will receive a single infusion of allogeneic CAR-T cells, which are cultured from healthy adult donors. This treatment is given through an intrathecal injection, meaning the cells are delivered directly into the fluid surrounding the brain and spinal cord. The study is open-label and involves only one treatment group receiving this experimental therapy. During the study, participants will undergo evaluations to monitor safety and treatment effects over a two-year period. Researchers will regularly assess tumor response and immune activity, and check for any side effects. Participants will have scheduled visits including tests of organ function, blood work, and imaging to measure tumor changes. Their overall health and quality of life will also be tracked throughout the study.
CONDITIONS
Brief 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 and provide written informed consent
- Aged 18 years or older at the time of consent
- Have recurrent or refractory glioma that has failed or cannot tolerate standard treatment
- Confirmed positive CD70 expression in tumor by cytology or histology (score 4+)
- At least one measurable lesion according to RANO criteria
- Expected survival of at least 12 weeks
- Baseline Kanofsky performance score of 70 or higher
- Adequate organ and bone marrow function as defined by specific laboratory values
- Fully recovered from previous treatment toxicities to Grade 1 or less except for specified exceptions
- Use effective contraception from consent until 6 months after CAR-T and until two negative PCR tests for CAR-T cells
- Negative pregnancy test within 7 days before first dose (for women of childbearing age)
You will not qualify if you...
- Received any CD70-targeted treatment within the last 3 years
- Received experimental drugs or devices within 28 days before CAR-T administration
- Received systemic anti-tumor treatments or certain Chinese medicines within specified timeframes before CAR-T
- Received radiotherapy within 3 months before administration
- Received non-CD70 targeted cell therapy within 2 months before administration
- Positive RCL test if previously treated with other cell therapies
- Received therapeutic glucocorticoids within 14 days before CAR-T (physiological doses allowed)
- Received oral or IV anticoagulation within 7 days before CAR-T
- Have other malignant tumors except certain cured or remission cases
- History of allogeneic organ or stem cell transplantation
- Have immunodeficiency, autoimmune diseases, or need immunosuppressants
- Received live vaccines within 14 days before screening or require live vaccines during study
- Severe or unstable systemic diseases including uncontrolled hypertension, hyperglycemia, liver/kidney dysfunction, or CNS diseases
- Known severe cardiovascular disease or specific heart conditions
- Positive tests for certain infections including HIV, CMV, EBV, hepatitis B or C
- Pregnant or lactating women
- Any other condition that may affect study compliance or suitability as judged by researchers
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) for tumor specimen testing and eligibility confirmation
Duration - Single treatment event with ongoing monitoring
Participants receive a single infusion of allogeneic CAR-T cells targeting CD70 administered intrathecally.
1 infusion visit followed by multiple safety and efficacy monitoring visits over 2 years
Trial Site Locations
Total: 1 location
1
Nanjing Jinling Hospital
China, Jiangsu, China, 210002
Actively Recruiting
Research Team
J
Jiang Longwei, master
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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