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This is a single arm, open-label, early phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Non-Hodgkin lymphoma treatment.
CD19-TriCAR contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the CD19-TriCAR-T/SILK to simultaneously targeting the CD19 positive Non-Hodgkin lymphoma,blocking the inhibitory PD-L1 signal and stimulating innate T/NK cell activation and expansion, thus make it a tri-functional CAR (Tri-CAR). CD19-TriCAR-T is an autologous tri-functional CAR-T cell therapy, CD19-TriCAR-SILK is an Allogeneic tri-functional CAR-NK cell therapy, patients ineligible for leukapheresis or CAR-T therapy will be recommended for CD19-TriCAR-SILK therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19-TriCAR-T/SILK | Experimental | CD19-TriCAR-T/SILK cells will be administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19-TriCAR-T/SILK | Biological | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of CD19-TriCAR-T cells or 4 repeat infusions of CD19-TriCAR-SILK cells. |
| Measure | Description | Time Frame |
|---|---|---|
| safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03) | Incidence of treatment-related adverse events as assessed by CTCAE v4.03 | 24 months |
| 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 | 24 months |
| Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yao Hongxia | Contact | +86 13876081106 | yaohongxia768@163.com | |
| Gao Bin | Contact | +86 13910899150 | bin.gaoa@timmune.com |
| Name | Affiliation | Role |
|---|---|---|
| Yao Hongxia | Hainan General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hainan Cancer Hospital | Recruiting | Haikou | Hainan | 570100 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28129122 | Background | 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. | |
| 28925994 |
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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 |
| 24 months |
| Duration of Response (The time from response to relapse or progression) | The time from response to relapse or progression | 24 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 | 24 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 |
| Hainan General Hospital | Recruiting | Haikou | Hainan | 570100 | China |
|
| The Second Affiliated Hospital of Hainan Medical University | Recruiting | Haikou | Hainan | 570100 | China |
|
| Background |
| 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. |
| 29499750 | Background | Porter D, Frey N, Wood PA, Weng Y, Grupp SA. Grading of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel. J Hematol Oncol. 2018 Mar 2;11(1):35. doi: 10.1186/s13045-018-0571-y. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |