Clinical Trial

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

Active, Not Recruiting Phase 1

Record status

This record was last updated December 11, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 9 amendments

This ClinicalTrials.gov record has been amended 9 times since 2021-05-18; most recent amendment 2025-12-09.

Status change: Recruiting → Active, Not Recruiting 2025-05-06

Status change: Not Yet Recruiting → Recruiting 2021-07-19

Trial Details

NCT Number	NCT04898543
Lead Sponsor	ImmunityBio, Inc.
Conditions	Metastatic Solid Tumor
Enrollment	50 participants
Start Date	2021-06-21
Primary Completion	2026-05-31 (estimated)
Study Completion	2026-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-11