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This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK/PD indexes of Senl-T7 were collected.
The CARs consist of an anti-CD7 single-chain variable fragment(scFv), a portion of the human CD137(4-1BB) molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD-7 CART | Experimental | Patients will be treated with CD7 CAR-T cells |
|
| 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 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity | First 1 month post CAR-T cells infusion |
| Remission Rate | To obsere the efficacy of CAR-T cells after infusion, complete remission (CR), complete remission with incomplete recovery of blood cells (CRi), minimal tumor residual positive(MRD+) or negative (MRD-) CR/CRi, disease recurrence or progression (PD) will be used for evaluation. | 3 months post CAR-T cells infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xian Zhang | Contact | 008618611636172 | xian_zhang@126.com | |
| Jianqiang Li, MD, PhD | Contact | 008615511369555 | limmune@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei yanda Hospital | Recruiting | Beijingcun | Hebei | China |
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| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |