drugset / Trial / NCT04898543

QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors

NCT04898543

Phase 1 Active not recruiting 50 enrolled ImmunityBio, Inc.
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

EvaluationDrugModalityDoseRoute
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

Indications