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

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary and study completion dates: May 31, 2025 to May 31, 2026v10
  2. Trial status: Recruiting to Active, Not Recruiting Primary and study completion dates: Mar 31, 2025 to May 31, 2025 · Site details revised at 2 of 2 sitesv9 Show 2 more changesShow less
    • Primary and study completion dates: Mar 31, 2025 to May 31, 2025
    • Site details revised at 2 of 2 sites
  3. Primary completion date: Jun 21, 2024 to Mar 31, 2025 Completion date: Dec 31, 2024 to Mar 31, 2025v8 Show 1 more changeShow less
    • Completion date: Dec 31, 2024 to Mar 31, 2025
  4. Primary endpoints revised (6) Interventions: Apheresis collection of lymphocytes (part A) (Other), M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Biological), N803… to Apheresis collection of MNCs (part A) (Other), M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B) (Biological)… · Eligibility criteria expanded, about 170 words · Secondary endpoints revised (10) · 2 morev7 Show 5 more changesShow less
    • Interventions: Apheresis collection of lymphocytes (part A) (Other), M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Biological), N803… to Apheresis collection of MNCs (part A) (Other), M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B) (Biological)…
    • Eligibility criteria expanded, about 170 words
    • Secondary endpoints revised (10)
    • Study description shortened, about 79 words
    • Site details revised at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Enrollment target: 30 to 50 Primary completion date: Jun 2022 to Jun 21, 2024 · Primary endpoints: 2 to 6 · Completion date: Jun 2022 to Dec 31, 2024 · 3 morev5 Show 6 more changesShow less
    • Primary completion date: Jun 2022 to Jun 21, 2024
    • Primary endpoints: 2 to 6
    • Completion date: Jun 2022 to Dec 31, 2024
    • Eligibility criteria expanded, about 178 words
    • Secondary endpoints: 14 to 10
    • Study description expanded, about 662 words

    See this version in full on ClinicalTrials.gov ↗

  2. Site contacts updated at 2 of 2 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2021 to Jun 21, 2021 · Site details revised at 2 of 2 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2021 to Jun 21, 2021
    • Site details revised at 2 of 2 sites
  4. Study sites: 1 to 2 Start date: May 2021 to Jun 2021v2 Show 1 more changeShow less
    • Start date: May 2021 to Jun 2021
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04898543
Lead Sponsor ImmunityBio, Inc.
Conditions Metastatic Solid Tumor
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov