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This is an open label, phase I study to assess the safety and efficacy of ThisCART19A in patients with AIDS related B cell lymphoma/lympholeukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ThisCART19A 2×10^6 cells/kg for dose level 1 | Experimental | Patients will receive 2×10^6 cells/kg of ThisCART19A |
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| ThisCART19A 3×10^6 cells/kg as dose level 2 | Experimental | Patients will receive 3×10^6 cells/kg of ThisCART19A |
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| Patients will receive 4×10^6 cells/kg as dose level 3 | Experimental | Patients will receive 4×10^6 cells/kg of ThisCART19A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThisCART19A | Biological | ThisCART19A is a new type CAR-T cells therapy for patients with lymphoma and lympholeukemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level | DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response rate in patients with AIDS related lymphoma | The incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment | 12 months |
| The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Ming Zhang, Doctor | Contact | 13656674208 | mingmingzhang@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| He Huang, Doctor | First hospital affiliated Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of medical college of zhejiang university | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D016483 | Lymphoma, AIDS-Related |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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Track CAR-T cells expansion in patients after infusion |
| 6 months |
| Analysis the change characteristics of cytokines and immune effect cells number in patients after infusion | Analysis the effect cells and cytokines in patients after infusion | 3 months |
| Analysis the severity and Incidence of Adverse Events in each dose level | Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, the adverse events with special consideration | 12 months |
| Analysis the immunogenicity(Anti-therapeutic antibody and neutralizing antibody) of CAR-T cells in patients after infusion | Analysis the Anti-therapeutic antibody and neutralizing antibody level after infusion | 24 months |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |