drugset / Trial / NCT04245722
FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I dose-finding study of FT596 as monotherapy and in combination with Rituximab or Obinutuzumab in subjects with relapsed/refractory B-cell Lymphoma or Chronic Lymphocytic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Timeline
- Start
- 2020-03-19
- Primary completion
- 2023-09-27
- Completion
- 2023-09-27
Publications
- Background Li Y, Hermanson DL, Moriarity BS, Kaufman DS. Human iPSC-Derived Natural Killer Cells Engineered with Chimeric Antigen Receptors Enhance Anti-tumor Activity. Cell Stem Cell. 2018 Aug 2;23(2):181-192.e5. doi: 10.1016/j.stem.2018.06.002. Epub 2018 Jun 28.
- Ghobadi A, Bachanova V, Patel K, Park JH, Flinn I, Riedell PA, Bachier C, Diefenbach CS, Wong C, Bickers C, Wong L, Patel D, Goodridge J, Denholt M, Valamehr B, Elstrom RL, Strati P. Induced pluripotent stem-cell-derived CD19-directed chimeric antigen receptor natural killer cells in B-cell lymphoma: a phase 1, first-in-human trial. Lancet. 2025 Jan 11;405(10473):127-136. doi: 10.1016/S0140-6736(24)02462-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FT596 | Cell therapy | 3e+07 cells | — |
| Subject | FT596 | Cell therapy | 1.8e+09 cells | — |
| Subject | Obinutuzumab | Monoclonal antibody | — | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Bendamustine | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |