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

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 rec

Trial Details

NCT ID
NCT06710288
Phase
PHASE2
Sponsor
ImmunityBio, Inc.
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Gemcitabine
  • N-803
  • M-CENK
Locations (sample)
  • El Segundo, California, United States|33.91918,-118.41647
  • Newport Beach, California, United States|33.61891,-117.92895

Key Eligibility Criteria

  • ≥18 years and \<85 years old.
  • Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committe…
  • Participants must be appropriate for single-agent therapy as the next line of therapy, as determined by the Investigator.
  • Participants must have received prior treatment with bevacizumab.

For full eligibility, visit ClinicalTrials.gov.

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