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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 patients 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. 4 CAR T dosage will be tested in this study: 1×10^7, 2.5×10^7, 5×10^7, 1×10^8 CAR+ T cells. |
|
| 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 |
|---|---|---|---|---|---|---|
| Ruijin hospital | Shanghai | Shanghai Municipality | 200025 | 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. | |
| 31444250 |
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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 |
| Yan ZX, Li L, Wang W, OuYang BS, Cheng S, Wang L, Wu W, Xu PP, Muftuoglu M, Hao M, Yang S, Zhang MC, Zheng Z, Li J, Zhao WL. Clinical Efficacy and Tumor Microenvironment Influence in a Dose-Escalation Study of Anti-CD19 Chimeric Antigen Receptor T Cells in Refractory B-Cell Non-Hodgkin's Lymphoma. Clin Cancer Res. 2019 Dec 1;25(23):6995-7003. doi: 10.1158/1078-0432.CCR-19-0101. Epub 2019 Aug 23. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |