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This study is an open and prospective clinical study, taking patients with relapsed or refractory CD7+ lymphoma as the test subjects, in order to evaluate the safety and efficacy of Senl-T7 CAR-T for patients with CD7+ lymphoma.
Main research purposes:
To evaluate the safety and efficacy of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma
Secondary research purpose:
To investigate the cytokinetic characteristics of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD7 CAR-T | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senl-T7 | Biological | Patients will be treated with CD7 CAR-T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence and severity of adverse events | To evaluate the possible adverse events occurred within first one month after CD7 | First 1 month post CAR-T cells infusion |
| Remission Rate | Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR) | 3 months post CAR-T cells infusion |
| duration of response (DOR) | duration of response (DOR) | 24 months post CAR-T cells infusion |
| progression-free survival (PFS) | progression-free survival (PFS) time | 24 months post CAR-T cells infusion |
| CAR-T proliferation | the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method | 3 months post CAR-T cells infusion |
| CAR-T proliferation | percentage of CD7 CAR- T cells measured by flow cytometry method | 3 months post CAR-T cells infusion |
| Cytokine release | Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method | First 1 month post CAR-T cells infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peihua MD Lu, PhD | Contact | 008618611636172 | peihua_lu@126.com | |
| Jianqiang MD Li, PhD | Contact | 008615511369555 | limmune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peihua MD Lu, PhD | Hebei Yanda Ludaopei Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei yanda Ludaopei Hospital | Recruiting | Yanda | Hebei | China |
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |