drugset / Trial / NCT04898543
QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a two-part, open-label phase 1 study to evaluate safety and preliminary efficacy of M-CENK Suspension for Infusion, Cryopreserved, and N-803 for subcutaneous administration in subjects with locally advanced or metastatic solid tumors. The study consists of two cohorts: cohort 1 includes subjects with either newly diagnosed solid tumors who have not received prior therapy or subjects who have received prior first line treatment; and cohort 2 that includes subjects with relapsed/refractory (r/r) solid tumors who have progressive disease after receiving ≥ 2 prior therapies. The two cohorts will be conducted simultaneously.
Timeline
- Start
- 2021-06-21
- Primary completion
- 2026-05-31
- Completion
- 2026-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | M-CENK | Cell therapy | 0.25 cells | Intravenous |
| Subject | M-CENK | Cell therapy | 0.75 cells | Intravenous |
| Subject | N-803 | Protein / enzyme biologic | 15 ug/kg | Subcutaneous |