drugset / Trial / NCT04464200
19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to test the safety of 19(T2)28z1xx CAR T cells in people with relapsed/refractory B-cell cancers. The researchers will try to find the highest dose of 19(T2)28z1xx CAR T cells that causes few or mild side effects in participants. Once they find this dose, they can test it in future participants to see if it is effective in treating their relapsed/refractory B-cell cell cancers. This study will also look at whether 19(T2)28z1xx CAR T cells work against participants' cancer.
Timeline
- Start
- 2020-07-06
- Primary completion
- 2026-07
- Completion
- 2026-07
Publications
- Park JH, Palomba ML, Perica K, Devlin SM, Shah G, Dahi PB, Lin RJ, Salles G, Scordo M, Nath K, Valtis YK, Lynch A, Cathcart E, Zhang H, Schoder H, Leithner D, Liotta K, Yu A, Stocker K, Li J, Dey A, Sellner L, Singh R, Sundaresan V, Tong X, Zhao F, Mansilla-Soto J, He C, Meyerson J, Hosszu K, McAvoy D, Wang X, Riviere I, Sadelain M. Results From First-in-Human Phase I Study of a Novel CD19-1XX Chimeric Antigen Receptor With Calibrated Signaling in Large B-Cell Lymphoma. J Clin Oncol. 2025 Jul 20;43(21):2418-2428. doi: 10.1200/JCO-24-02424. Epub 2025 Jan 30.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 19(T2)28z1xx CAR T cells | Cell therapy | 1.25e+07 cells | Intravenous |
| Subject | 19(T2)28z1xx CAR T cells | Cell therapy | 2.5e+07 cells | Intravenous |
| Subject | 19(T2)28z1xx CAR T cells | Cell therapy | 5e+07 cells | Intravenous |
| Subject | 19(T2)28z1xx CAR T cells | Cell therapy | 1e+08 cells | Intravenous |
| Subject | 19(T2)28z1xx CAR T cells | Cell therapy | 2e+08 cells | Intravenous |