Phase I/II Study of Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
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- STATUS
- Recruiting
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- End date
- Sep 8, 2024
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- participants needed
- 25
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- sponsor
- Beijing Boren Hospital
Summary
This is a open-label, nonramdominzed, single-arm, Phase I/II Study to evaluate safety and tolerability of functionally enhanced CD33 CAR-T cells in subjects with relapsed or refractory acute myeloid leukemia. 25 subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 5 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m^2( body surface area) and cyclophosphamide 250 mg/m^2( body surface area) for 3 days. Then the Bayesian optimal interval phase I/II (Boin12) trial design will be used in this study: The protocol preset 2 dose levels: Dose 1 (DL-1) was 510^5 (20%) CAR T cells/kg, and dose 2 (DL-2) was 110^6 (20%) CAR T cells/kg. Phase I was the dose exploration phase. After determining the optimal biological dose (OBD), phase II will be expanded at the OBD dose by 10 cases, enrollment will reach 25 cases, and the trial will be discontinued. Moreover, the first 3 enrolled subjects per dose group will be on one by one dosing regimen.
The expected initial dose of 510^5 (20%) CAR T cells/kg could not be achieved due to preparation problems and should be placed in the reduced dose group. The number of cells will be collected by the above regimen as far as possible. If this is not possible, subjects can still enter the study upon investigator consideration but require documentation of dosing. The lowest dose is 110^5 CAR T cells/kg (20%), and the highest dose is 110^6 CAR T cells/kg (20%). If the dose is out of the range mentioned above, entry into the trial will not be considered.
Details
| Condition | Acute myeloid leukemia, Relapse Leukemia, acute myeloblastic leukemia, Refractory Acute Myeloid Leukemia, refractory acute myeloid leukemia (aml), anll, Acute Myeloid Leukemia, acute myelogenous leukemia, Acute Myelogenous Leukemia (AML) |
|---|---|
| Treatment | Chimeric antigen receptor T cell |
| Clinical Study Identifier | NCT04835519 |
| Sponsor | Beijing Boren Hospital |
| Last Modified on | 23 September 2021 |
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