drugset / Trial / NCT01840566
High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to test the safety of delivering the patients' own immune cells, called T cells, after the high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT).
Timeline
- Start
- 2013-04
- Primary completion
- 2027-04
- Completion
- 2027-04
Publications
- 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.
- Sauter CS, Senechal B, Riviere I, Ni A, Bernal Y, Wang X, Purdon T, Hall M, Singh AN, Szenes VZ, Yoo S, Dogan A, Wang Y, Moskowitz CH, Giralt S, Matasar MJ, Perales MA, Curran KJ, Park J, Sadelain M, Brentjens RJ. CD19 CAR T cells following autologous transplantation in poor-risk relapsed and refractory B-cell non-Hodgkin lymphoma. Blood. 2019 Aug 15;134(7):626-635. doi: 10.1182/blood.2018883421. Epub 2019 Jul 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 19-28z T CELLS | Cell therapy | 5e+06 cells/kg | — |
| Subject | 19-28z T CELLS | Cell therapy | 1e+07 cells/kg | — |
| Subject | 19-28z T CELLS | Cell therapy | 2e+07 cells/kg | — |
| Background | Cytarabine | Small molecule | — | — |
| Background | Etoposide | Small molecule | — | — |
| Background | Melphalan | Small molecule | — | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Background | carmustine | Small molecule | — | — |