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| Name | Class |
|---|---|
| Shanghai Mingju Biotechnology Co., Ltd. | UNKNOWN |
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This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells in adult subjects with relapsed and refractory B-cell Non-Hodgkin lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JWCAR029 | Experimental | The safety and efficacy of JWCAR029 will be evaluated in a standard 3+3 dose escalation approach. 5 CAR T dosage will be tested in this study: 1×10^7, 2.5×10^7, 5×10^7, 1×10^8, 1.5^108 CAR+ T cells. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JWCAR029 | Biological | Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with JWCAR029 by intravenous (IV) injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related adverse events (AEs) | Physiological parameter | 2 years |
| Dose-limiting toxicities of JWCAR029 | Physiological parameter | 28 days after JWCAR029 infusion |
| Objective response rate (ORR) | Lugano criteria | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of JWCAR029 in the peripheral blood and bone marrow | Flow cytometry and qPCR | 1 year after JWCAR029 infusion |
| Time to maximum concentration (Tmax) of JWCAR029 in the peripheral blood and bone marrow |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be enrolled in this study:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from participation in this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34515338 | Derived | Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000718412 | relmacabtagene autoleucel |
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Flow cytometry and qPCR
| 1 year after JWCAR029 infusion |
| Area-under the concentration-vs-time-curve (AUC) of JWCAR029 in the peripheral blood and bone marrow | Flow cytometry and qPCR | 1 year after JWCAR029 infusion |
| Complete response (CR) rate | Lugano criteria | 2 years |
| Duration of response | Lugano criteria | 2 years |
| Progression-free survival (PFS) and PFS ratio | Lugano criteria | 2 years |
| Overall survival | Physiological parameter | 2 years |
| Health-related quality of life (HRQoL) | Questionnaire | 2 years |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |