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Safety and Efficacy of BT-007 CAR-T Cells in the Treatment of Patients With Relapsed/Refractory T Cell Lymphoblastic Lymphoma (R/R T-LBL)
This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of T cells expressing CD7 chimeric antigen receptors (referred to as "BT-007 CAR-T cells") in patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL).
Details
| Lead sponsor | Bioceltech Therapeutics, Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 15 |
| Start date | 2022-10 |
| Completion | 2024-09 |
Conditions
- T Cell Lymphoblastic Lymphoma
Interventions
- BT-007 CD7 CAR-T cells
Primary outcomes
- Objective response rate (ORR) — The changes between baseline and Day 28, Month 3, Month 6, as well as Month 24 for termination.
The percentage of participants who achieved complete remission (CR) over all participants. The tumor status of patient is assessed for the baseline when assigned into treatment group. The overall CR is assessed by the Lugano Classification Lymphoma Response Criteria 2014 on Day 28, Month 3, Month 6, as well as Month 24 for termination. The overall CR is also assessed for the case withdraw from treatment before the termination of 24 months. The percentage of participants who achieved partial remission (PR) over all participants. The assessment criteria and time frame are the same as CR.
Countries
China