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A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 1 of 2 sitesv6
  2. Site contacts updated at 1 of 2 sitesv5
  3. Study sites: 1 to 2 Start date changed from estimate of Mar 2025 to Nov 6, 2024v4 Show 1 more changeShow less
    • Start date changed from estimate of Mar 2025 to Nov 6, 2024
  4. Start date: Dec 2024 to Mar 2025 Site contact updatedv3 Show 1 more changeShow less
    • Site contact updated
  5. Trial status: Not Yet Recruiting to Recruiting Start date: Nov 2024 to Dec 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Nov 2024 to Dec 2024
    • Site details revised
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
ImmunityBio, Inc.
33 trials monitored
See 2 trials at risk
Ovarian Cancer
1,245 trials monitored
See 80 trials at risk
This is phase 2 single arm study evaluating the safety and preliminary efficacy of M-CENK adoptive cell therapy and fixed dose of N-803 in combination with gemcitabine in participants with platinum-resistant high-grade ovarian cancer (HGOC).Up to 20 participants will receive M-CENK (IV) and N-803 (SC) in combination with gemcitabine (IV). Participants will undergo an apheresis procedure for the collection of mononuclear cells (MNCs) at least 1 day prior to Cycle 1 for manufacturing of M-CENK. Starting in Cycle 1, participants will receive gemcitabine and starting in Cycle 2 they will also receive M-CENK and N-803, until no additional M-CENK is available or confirmed PD per iRECIST, unless the participant is potentially deriving benefit per Investigator's assessment. Participants who complete the study treatment or discontinue study treatment will be followed for survival/disease status every 12 weeks (± 2 weeks) for up to 12 months after the last study treatment or until death, lost to follow-up, or withdrawal of consent.
Trial Details
NCT Number NCT06710288
Lead Sponsor ImmunityBio, Inc.
Conditions Platinum-resistant Ovarian Cancer
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov