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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: Active Phase 1 study of Metastatic Solid Tumor, sponsored by ImmunityBio.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
\- Safety of apheresis collection as indicated by incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to apheresis, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, or in the case of cytokine release syndrome (CRS), using the specified grading system.
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
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-06-21 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
What the registry record for NCT04898543 still lists
NCT04898543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 191-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (74% lower).
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 a single indexed study location in 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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