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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).
Primary objective:
To investigate the safety and efficacy of CD7 CAR-T cells in the treatment of patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL).
Secondary objective:
To assess the patient's quality of life after receiving the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BT-007 CD7 CAR-T cells in R/R T-LBL | Experimental | Subjects will receive BT-007 CD7 CAR-T cells infusion on Day 0 : 100% of total dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT-007 CD7 CAR-T cells | Biological | T cells purified from the peripheral blood mononuclear cell (PBMC) of subjects or subjects' relatives which depend on their conditions, transduced with 4-1BB/CD3ζ lentiviral vector, expanded in vitro for future administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 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. | The changes between baseline and Day 28, Month 3, Month 6, as well as Month 24 for termination. |
| Measure | Description | Time Frame |
|---|---|---|
| The retention amount of CAR-T cells remaining in vivo | The retention amount of CAR-T cells in all subjects within 24 months when terminated. The retention amount of CAR-T cells in all subjects is assessed on Day 1, 7, 14, 28 during first month after cell infusion. The retention amount is also assessed every month during Month 2 and 6, and every three months during Month 6 and 24 when terminated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongwei Xu, MD, PhD | Contact | +0086-10-69739722 | willyxu001@bioceltech.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiping Liu, MD, PhD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
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| The retention amount of CAR-T cells in all subjects is assessed on Day 1, 7, 14, 28 during first month after cell infusion, and every month during Month 2 and 6, and every three months during Month 6 and 24 when terminated. |
| The retention time of CAR-T cells remaining in vivo | The retention time of CAR-T cells in all subjects within 24 months when terminated. The retention time of CAR-T cells in all subjects is assessed on Day 1, 7, 14, 28 during first month after cell infusion. The retention time is also assessed every month during Month 2 and 6, and every three months during Month 6 and 24 when terminated. | The retention time of CAR-T cells in all subjects is assessed on Day 1, 7, 14, 28 during first month after cell infusion, and every month during Month 2 and 6, and every three months during Month 6 and 24 when terminated. |