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| Name | Class |
|---|---|
| Nanjing Bioheng Biotech Co., Ltd. | INDUSTRY |
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This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RD13-02 cell infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RD13-02 cell infusion | Drug | CAR-T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity and Maximum Tolerated dose | The DLT is evaluated as the proportion of patients who experienced adverse events related to RD13-02 that meet the criteria for DLT events after the first infusion. | Up to 28 days after CAR-T cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate,ORR | The proportion of patients with CR (complete remission) /CRi (complete remission with incomplete blood count recovery); The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response). | Evaluate at 4, 8, and 12 weeks after CAR-T infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of medical college of zhejiang university | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| Overall response rate with MRD-negative,MRD-ORR | Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow | Up to 1 years after CAR-T infusion |
| Duration of remission,DOR | The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion | Up to 1 years after CAR-T infusion |
| Event-free survival, EFS | The time from first achieving CR/CRi to relapse or death | Up to 1 years after CAR-T infusion |
| The proportion of patients who receive hematopoietic stem cell transplantation | The proportion of patients who receive hematopoietic stem cell transplantation | Up to 1 years after CAR-T infusion |
| Overall survival, OS | The time from CAR-T infusion to death due to any cause | Up to 1 years after CAR-T infusion |