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

NCT04898543 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-11

No results posted yet for this study

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.

Conditions

  • Metastatic Solid Tumor

Interventions

BIOLOGICAL

M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B)

M-CENK will be administered up to 10 times weekly via intravenous (IV) infusion starting on study day 1 with a minimum of 7 days between each M-CENK dose. The dose of MCENK will be 0.25 - 0.75 × 10e9 cells per infusion.

BIOLOGICAL

N-803 (Cohort 2 part B)

N-803 15 μg/kg will be administered subcutaneously prior to every other dose of M-CENK for up to 5 doses of N-803.

OTHER

Apheresis collection of MNCs (part A)

Subjects in cohort 1A will participate in apheresis collection of lymphocytes (part A) and will not receive any investigational therapy in this study.

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Leonard Sender, MD · ImmunityBio, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898543 on ClinicalTrials.gov