drugset / Trial / NCT05618925
Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma
RandomizedSingle-groupOpen-labelTreatment
Summary
Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma. Up to 20 subjects will be enrolled and randomized 1:1 to 1 of 2 cohorts, as outlined below. The initial 3 subjects will be sequentially enrolled in a staggered fashion, with a 7 day interval between each subject to enable the capture and monitoring of any acute and subacute toxicities.
Timeline
- Start
- 2025-08-22
- Primary completion
- 2026-05-15
- Completion
- 2027-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD19 t-haNK | Cell therapy | — | — |
| Subject | N-803 | Protein / enzyme biologic | — | — |
| Subject | Rituximab | Monoclonal antibody | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |