Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single arm, open-label, phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T, an autologous tri-functional anti- CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in Refractory/ Relapsed CD19 Positive 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 CD19-TriCAR-T to simultaneously targeting the CD19 positive NHL cells,blocking the inhibitory PD-L1 signal and stimulating T/NK cell activation and expansion.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19-TriCAR-T | Experimental | Tri-functional anti-CD19 chimeric antigen receptor transduced autologous T cells will be administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19-TriCAR-T | 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 0.1-1 x 10^6 CAR+ T cells/kg body weight. |
| 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) |
Not provided
Inclusion Criteria:
All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
All subjects must be able to comply with all the scheduled procedures in the study;
Histologically or cytologically confirmed CD19 positive non-Hodgkin lymphoma;
At least one measurable lesion per revised IWG Response Criteria;
Aged 18 to 69 years;
Expected survival ≥12 weeks;
Eastern cooperative oncology group (ECOG) performance status of ≤2;
Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
All other treatment induced adverse events must have been resolved to
≤grade 1;
Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB >70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haifeng Lin | Contact | +86 13322060949 | 13322060949@163.com | |
| Bin Gao, Dr. | Contact | +86 022 59060560 | bin.gao@timmune.com |
| Name | Affiliation | Role |
|---|---|---|
| Haifeng Lin | The Second Affiliated Hospital of Hainan Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Hainan Medical University | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| 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. |
| 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. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |