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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 6, 2024

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

Conditions
Platinum-resistant Ovarian Cancer
Interventions
DRUG

Gemcitabine

Dose: 800 mg/m2 intravenously (IV) Frequency: administered on Day 1, Day 8, and Day 15 of each cycle (every 4 weeks)

BIOLOGICAL

N-803

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).

BIOLOGICAL

M-CENK

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.

Trial Locations (2)

90245

RECRUITING

Chan Soon-Shiong Institute for Medicine, El Segundo

92663

RECRUITING

Hoag, Newport Beach

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImmunityBio, Inc.

INDUSTRY