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This is a phase I, single center study to assess the efficacy and safety of ThisCART19A in adult with Non-Hodgkins Lymphoma in China.
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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 |
|
| 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 | each patient will receive a dose level per body weight(kg) for only once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limited toxicity(DLT) observation in patient with NHL during dose escalation stage | DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level. | 28 days |
| Objective Response Rate in patient with NHL during dose expansion stage | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate during dose escalation stage and expansion stage | 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 |
| Duration of response(DOR) during dose escalation stage and expansion stage |
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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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The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) |
| 12 months |
| OS(overall survival) during dose escalation stage and expansion stage | Overall survival (OS) is defined as the time from the date of lymphodepletion until death from any cause. | 12 months |
| Time to remission(TTR) during dose escalation stage and expansion stage | Time to remission(TTR) is defined as the time from the date of ThisCART19A infusion until the date of first remission. | 12 months |
| Analysis the change characteristics of CART cell number and copy number during dose escalation and expansion stages | Track CAR T cells expansion in patients after infusion | 6 months |
| Analysis the change characteristics of cytokines and immune effect cells number during dose escalation and expansion stages | Analysis the effect cells and cytokines in patient after infusion | 3 months |
| Analysis the severity and Incidence of Adverse Events in each dose level during dose expansion stage | Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, or the adverse events with special attention | 3 months |
| Analysis the immunogenicity(anti-therapeutic antibody and neutralizing antibody) of CAR-T cells after infusion | 12 months |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| 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 |
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