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

Part of paid clinical trials in El Segundo, California.

Sponsor
ImmunityBio, Inc.
Study ID
NCT06710288
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Dose: 800 mg/m2 intravenously (IV) Frequency: administered on Day 1, Day 8, and Day 15 of each cycle (every 4 weeks)
  • N-803 — BIOLOGICAL
    Dose: fixed dose of 1.2 mg subcutaneously (SC) Frequency: administered on Day 1 and Day 15 of each cycle starting at Cycle 2 (every 4 weeks) and when the last dose of M-CENK is administered, N-803 will be administered on Days 1 and 15 of the same cycle followed by 3 additional doses, 2 weeks apart (total of 5 N-803 doses).
  • M-CENK — BIOLOGICAL
    Dose: 0.15 to 0.75 × 109 cells per infusion intravenously (IV) Frequency: administered on Day 1 of each cycle as long as M-CENK cells are available.

Study Details

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.

Key Dates

Start date
Nov 6, 2024
Status verified
Oct 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All subjects
    Gemcitabine plus M-CENK plus N-803

Primary Outcome Measure

Evaluate Progression Free Survival (PFS) [ Time Frame: Cycle 1 Day 1 through End of Study, up to 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Chan Soon-Shiong Institute for MedicineEl SegundoCalifornia90245
Jacqui Parnin
[email protected]
213-266-5604
Jaya (Mini) Gill
[email protected]
213-266-5639
Chaitali Nangia, MD (PRINCIPAL_INVESTIGATOR)
HoagNewport BeachCalifornia92663
Tiffany Beck, M.D., MPH, FACOG
[email protected]
949-642-1361
Ana Navarrete
[email protected]
Tiffany L Beck, M.D., MPH, FACOG (PRINCIPAL_INVESTIGATOR)

Find similar trials in El Segundo, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Chan Soon-Shiong Institute for Medicine· El Segundo, CAHoag· Newport Beach, CA

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