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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Shanghai Liquan Hospital | OTHER |
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This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD5 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD5 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD5 CAR-T therapy | Experimental | Enrolled patients were treated with anti-CD7 CAR-T cells, with or without allo-HSCT bridging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD5 CAR-T cells infusion | Drug | Approximately 3-5 days prior to CD5 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD7 CAR-T infusion. | 21 days |
| Adverse events (AEs) | Total number, incidence and severity of adverse events (AEs) within 21 days of CD7 CAR-T infusion. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The assessment of ORR by dose group at 21 and 90 Days after CD7 CAR T infusion. | 21, 90 days |
| Duration of response (DOR) | DOR is defined as the date when CR response criteria are first met to the date of relapse or death caused by T-NHL in the absence of documented relapse |
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Inclusion Criteria (Patients who met all the inclusion criteria were eligible for enrolment):
Exclusion Criteria (Patients who fulfil any of the following criteria may not be enrolled):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyang LU, Ph.D | Contact | 86+ 18221015770 | lhy13062@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tengyu Wang, Ph.D | Beijing GoBroad Hospital, Beijing, Beijing 102200 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Hospital | Recruiting | Beijing | 102200 | China |
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| up to 2 years |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200025 | China |
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| Shanghai Liquan Hospital | Recruiting | Shanghai | 200435 | China |
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |