Status:
UNKNOWN
Clinical Study of CLL1 CAR-T Cells in the Treatment of Hematological Malignancies
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Yake Biotechnology Ltd.
Conditions:
AML
Eligibility:
All Genders
Phase:
EARLY_PHASE1
Brief Summary
Clinical Study on the Safety and Effectiveness of CLL1 CAR-T Cells in the Treatment of CLL1-positive Hematological Malignancies
Detailed Description
Human C-type lectin-like molecule 1 (CLL1) is a type II transmembrane glycoprotein ，CLL1 expression is restricted to bone marrow cells and most AML blasts. In addition, CLL1 is expressed in leukemia s...
Eligibility Criteria
Inclusion
- 1\. Patients is histologically diagnosed with CLL1-positive AML according to the NCCN Clinical Practice Guidelines in Oncology：Acute Myeloid Leukemia（Version 2.2021） 2. The diagnosis is consistent with r/r CLL1 + AML, and includes any of the following conditions:
- No CR was obtained after 2 courses of standard chemotherapy
- The first induction was CR, but the duration of CR was less than 12 months
- No CR was obtained after the first or multiple remedial treatment;
- Relapse twice or more; 3. The number of blast cells in bone marrow was more than 5% (morphology) and / or \> 1% (flow cytometry).
- 4\. No active lung infection, inhaled air oxygen saturation ≥92% 5. The estimated survival time is more than 3 months 6. ECOG score was 0-2 7. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
Exclusion
- 1\. Patients with history of epilepsy or other central nervous system diseases; 2. Patients with prolonged QT or severe heart disease; 3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown); 4. The patients with uncontrolled active infection; 5. Active hepatitis B or hepatitis C virus infection; 6. Previous application of gene therapy; 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 8. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl; 9. Those who suffer from other uncontrolled diseases are not suitable to join the study; 10. HIV infection; 11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05252572
Start Date
February 28 2022
End Date
November 30 2024
Last Update
February 23 2022
Active Locations (2)
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1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
2
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310003