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The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting CD7 in patients with relapsed or refractory CD7 positive T-cell hematological maliganacies
This study is single-armed,open lable,dose escalation clinical trial.The main purpose is to evaluate the safety and efficacy of anti-CD7 CAR-T cells in relapsed/refractory patients with CD7 positive T cell malignancies,including T lymphoblastic lymphoma/leukemia ,T-cell non-Hodgkin lymphoma(peripheral T cell lymphoma,NOS,angioimmunoblastic T cell lymphoma and anaplastic large cell lymphoma).There will be three CAR T cell dose groups:0.25*10^6 cells per kilogram of body weight;0.5*10^6 cells per kilogram of body weight,1 *10^6 ells per kilogram of body weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-CD7 CAR T cells | Experimental | Administration with anti-CD7 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD7 CAR-T cells | Drug | Administration with anti-CD7 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | The occurence of study related adverse effects defined by NCI CTCAE5.0 | 28 days post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| CAR-T cell expansion | Using flow cytometry to reveal cell surface expression of the CAR protein on T cells;and using quantitative polymerase chain reaction to detect DNA copies of the transgene irrespective of gene expression(per ug DNA) to evaluate anti-CD7 CAR-T cell expansion after infusion | 2 years post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of CAR-T cells | Using flow cytometry to detect whether anti-car antibodies are contained in serum of patients receiving CAR-T cells infusion,and to evaluate the number of participants with antibodies | 2 years post infusion |
Inclusion criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xianmin G Song, M.D. | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xianmin General Song | Shanghai | China |
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| CAR-T cell persistence |
Using flow cytometry to reveal cell surface expression of the CAR protein on T cells;and using quantitative polymerase chain reaction to detect DNA copies of the transgene irrespective of gene expression(per ug DNA) to evaluate anti-CD7 CAR-T cell persistence after infusion |
| 2 years post infusion |
| Number of CD7+ lymphocytes of peripheral blood | To evaluate CD7 positive cells of peripheral blood after infusion | 2 years post infusion |
| Total response rate (ORR) after administration | CR+CRi for T-ALL ;CR+PR for T cell lyphoma and T lymphoblastic lymphoma | 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 administration | Progression Free Survival (PFS) after administration | 2 years post infusion |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D007119 | Immunoblastic Lymphadenopathy |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007938 | Leukemia |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| 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 |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D006402 | Hematologic Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D000072281 | Lymphadenopathy |
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