Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| iCAR Bio Therapeutics Ltd. | INDUSTRY |
| Peking University Shenzhen Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia
Anti-CD7 CAR is a chimeric antigen receptor immunotherapy treatment designed to treat leukemia/lymphoma expressing CD7 antigen. T-cell acute lymphoblastic leukemia, T-acute lymphoblastic lymphoma and T-cell non-Hodgkin lymphoma are a subset of leukemias and lymphomas that are positive for the surface protein CD7. The purpose of this study is to evaluate the efficacy and safety of anti-CD7 CAR T cells.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-CD7 CAR T cells | Experimental | anti-CD7 CAR T cells Dose escalation phase: anti-CD7 CAR T cells transduced with a lentiviral vector to express CD7 chimeric receptor domain on T cells with an escalation approach, 1 e6 to 5 e6 CAR-T cells/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD7 CAR T cells | Biological | Non-gene edited anti-CD7 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 |
|---|---|---|
| Dose limiting toxicity (DLT) | Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | The first 28 days after infusion |
| Type of dose-limiting toxicity (DLT) | Type of dose-limiting toxicity (DLT) | The first 28 days after infusion |
| Adverse event by severity | Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate of ant-CD7 CAR | Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies | 1 year |
| Progression-free survival (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Peking University Shenzhen Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D016399 | Lymphoma, T-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Progression-free survival (PFS) |
| 1 year |
| Overall survival | Overall survival | 1 year |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |