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| Name | Class |
|---|---|
| Hunan Provincial People's Hospital | OTHER |
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This is a single arm, open-label, single-center, phase 1/2 study, to determine the safety and efficacy of TriCAR-T-CD19, an autologous tri-functional anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory/Relapsed Non-Hodgkin Lymphoma (NHL).
The tri-functional anti-CD19 chimeric antigen receptor contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the TriCAR-T-CD19 to simultaneously targeting the CD19 positive NHL,blocking the inhibitory PD-L1 signal and stimulating T/NK cell activation and expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TriCAR-T-CD19 | Experimental | Tri-functional anti-CD19 chimeric antigen receptor transduced autologous T cells will be administered intravenously |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TriCAR-T-CD19 | Biological | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously at a target dose of 0.5-1 x 10^6 CAR+ T cells/kg |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.0) | Incidence of treatment-related adverse events as assessed by CTCAE v4.0 | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma) | Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma | 12 months |
| Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Zhou | Contact | +86 0731 83928147 | zhouming_0321@163.com | |
| Bin Gao | Contact | +86 022 59060560 | 803 | bin.gao@timmune.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Zhou | Hunan Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | 410005 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21832238 | Background | Kalos M, Levine BL, Porter DL, Katz S, Grupp SA, Bagg A, June CH. T cells with chimeric antigen receptors have potent antitumor effects and can establish memory in patients with advanced leukemia. Sci Transl Med. 2011 Aug 10;3(95):95ra73. doi: 10.1126/scitranslmed.3002842. | |
| 28129122 | Result | Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 Results of ZUMA-1: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. doi: 10.1016/j.ymthe.2016.10.020. Epub 2017 Jan 4. |
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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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Partial response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma |
| 12 months |
| Duration of Response (The time from response to relapse or progression) | The time from response to relapse or progression | 12 months |
| Progression Free Survival(The time from the first day of treatment to the date on which disease progresses.) | The time from the first day of treatment to the date on which disease progresses. | 12 months |
| Overall Survival(The number of patient alive, with or without signs of cancer) | The number of patient alive, with or without signs of cancer | 24 months |
| 28925994 | Result | Neelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, Locke FL, Komanduri KV, Lin Y, Jain N, Daver N, Westin J, Gulbis AM, Loghin ME, de Groot JF, Adkins S, Davis SE, Rezvani K, Hwu P, Shpall EJ. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |