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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 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory natural killer/T cell lymphoma, 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 | RD13-02 cells targeting CD7 were injected intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RD13-02 cell infusion | Drug | CAR-T cells |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) | Evaluate at 4 weeks after CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heng Mei, Ph.D&M.D | Contact | 027-8572600 | hmei@hust.edu.cn | |
| Yinqiang Zhang | Contact | 15007101371 | zhang_yq@hust.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
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The time from first achieving CR/CRi to relapse or death
| 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 |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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