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The trial was suspended due to the inability to enroll qualified participants
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The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1 positive T-cell hematological maliganacies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-TRBC1 CAR-T cell | Experimental | Administration with anti-TRBC1 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-TRBC1 CAR-T cell therapy | Drug | TRBC1 positve patients with relapsed or refractory T cell malignacy will receive CAR-T cell therapy targetting TRBC1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0 | 28 days post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| CAR-T cell expansion and persistence | To evaluate anti-TRBC1 CAR-T cell expansion and persistence after infusion | 2 years post infusion |
| Total response rate (ORR) after administration | CR+CRi for T-ALL CR+PR for T cell lyphoma |
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Inclusion Criteria:
(1)18 to 70 Years Old, Male and female; (2) Expected survival > 12 weeks; (3) ECOG score 0-2; (4) Confirmed diagnosis of acute T cell leukemia and screened for TRBC1 positive, including following conditions:
a. Peripheral T cell lymphoma NOS, or b. Angioimmunoblastic T cell lymphoma, or c. Anaplastic large cell lymphoma (6) Confirmed T lymphoblatic lymphoma
a. Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction >50%; c. Baseline oxygen saturation>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST ≤ 3×ULN; (9) Able to understand and sign the In
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xianmin Song | Shanghai | Shanghai Municipality | 200080 | China |
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| 3 months post infusion |
| Duration of remission (DOR) after administration | Duration of remission (DOR) after administration | 2 years post infusion |
| Overall Survival (OS)after administration | Overall Survival (OS)after administration | 2 years post infusion |
| Progression Free Survival (PFS) after infusion | Progression Free Survival (PFS) after infusion | 2 years after infusion |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D007119 | Immunoblastic Lymphadenopathy |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072281 | Lymphadenopathy |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
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