Status:
UNKNOWN
Clinical Study of CD38 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 CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
Detailed Description
The CAR-T cell injection uses immune cells from healthy donors, and is the final product obtained after CAR genetic modification, cell expansion, culture, screening, preparation, sub-packaging, and re...
Eligibility Criteria
Inclusion
- 1\. Patients is histologically diagnosed with CD38-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 CD38 + 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 :
December 5 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05239689
Start Date
February 28 2022
End Date
December 5 2024
Last Update
February 15 2022
Active Locations (1)
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1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003