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NCT04898543 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Solid Tumor, sponsored by ImmunityBio.

Active
Registry status
Phase 1
Development phase
50
Enrollment target
2
Study locations

NCT04898543 is a Phase 1 study of Metastatic Solid Tumor that is active but no longer recruiting, run by ImmunityBio. The registered enrollment target is 50 participants, below the 191-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT04898543, a Phase 1 study of Metastatic Solid Tumor, is active but no longer recruiting, sponsored by ImmunityBio.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
50 participants
Enrollment target
2
Study locations

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 Studied

Interventions

  • BIOLOGICAL M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B)
  • BIOLOGICAL N-803 (Cohort 2 part B)
  • OTHER Apheresis collection of MNCs (part A)

Study Locations (2)

California

  • Chan Soon-Shiong Institute for Medicine - El Segundo
  • Hoag Memorial Hospital Presbyterian - Newport Beach

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2021-06-21
Est. Completion 2026-05-31
Phase Phase 1

Sponsor

ImmunityBio

46 total trials

What the Registry Record Tells You About NCT04898543

The ClinicalTrials.gov registry entry for NCT04898543 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 191-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (74% lower). The listed sponsor is ImmunityBio, which has 46 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 3 interventions - of which M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B) is the first listed.

NCT04898543 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04898543 about?

NCT04898543 is a clinical study titled "QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors". 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 subj...

What is the current status of trial NCT04898543?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2021-06-21. Estimated completion is 2026-05-31.

What conditions does trial NCT04898543 study?

This clinical trial studies the following conditions: Metastatic Solid Tumor.

What interventions are being tested in trial NCT04898543?

The interventions under investigation include: M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B) (BIOLOGICAL), N-803 (Cohort 2 part B) (BIOLOGICAL), Apheresis collection of MNCs (part A) (OTHER).

Who is sponsoring clinical trial NCT04898543?

This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04898543 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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