drugset / Trial / NCT07510828
PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This Phase 1/2, open-label, biomarker-guided platform study evaluates the safety, tolerability, and preliminary anti-tumor activity of banked allogeneic donor-derived chimeric antigen receptor natural killer (CAR-NK) cells in adults with advanced solid tumors. During screening, tumor antigen profiling is performed using tissue biopsy and/or liquid biopsy (circulating tumor DNA and/or circulating tumor cells). Participants are assigned to receive either a single-target CAR-NK product (matched to the dominant tumor antigen) or a dual-target CAR-NK product (matched to two co-expressed antigens) to reduce the risk of antigen escape.
Timeline
- Start
- 2026-03-02
- Primary completion
- 2027-03-14
- Completion
- 2028-04-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EB-PT-CAR-NK-D | Unknown | — | Intravenous |
| Subject | EB-PT-CAR-NK-S | Unknown | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | aldesleukin | Protein / enzyme biologic | — | — |
Indications
No indication recorded.