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| Name | Class |
|---|---|
| iCAR Bio Therapeutics Ltd. | INDUSTRY |
| Peking University Shenzhen Hospital | OTHER |
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This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.
CD4-specific CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD4 antigen. CD4+ T cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein CD4. The purpose of this study is to evaluate the efficacy and safety of CD4 CAR T cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD4 CAR T cells | Experimental | Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD4 CAR T cells | Biological | CD4 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events after CD4 CAR T cells cell infusion | Determine the toxicity profile of CD4 CAR T cell therapy | 2 years particularly the first 28 days after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Incidence of treatment-emergent adverse events | up to 6 months |
| Disease Free Survival (DFS) | Disease Free Survival (DFS) (IMWG criteria) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Pinz, MS | Contact | 6315386218 | kevin.pinz@icellgene.com | |
| Yupo Ma, MD/PhD | Contact | 7024658132 | yupo.ma@icellgene.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongyu Zhang, MD/PhD | Peking University Shenzhen Hospital, China | Principal Investigator |
| Fang Liu, MD/PhD | Chengdu Military Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | China |
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D015458 | Leukemia, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg
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| up to 2 years |
| Progression-Free Survival (PFS) | Progression-Free Survival (IMWG criteria) | up to 2 years |
| Overall Survival (OS) | overall survival | up to 2 years |
| Chengdu Military General Hospital | Not yet recruiting | Chengdu | Sichuan | China |
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |