RecruitingPhase 2NCT06710288

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

A Phase 2, Open-label, Single-arm Study Of Autologous Memory Cytokine Enriched Natural Killer (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


Sponsor

ImmunityBio, Inc.

Enrollment

20 participants

Start Date

Nov 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of a patient's own immune cells (called NK cells, re-engineered in the lab) plus an immune booster (N-803) and the chemotherapy drug gemcitabine for women with ovarian cancer that has come back after platinum-based chemotherapy. **You may be eligible if...** - You are between 18 and 84 years old - You have high-grade ovarian, fallopian tube, or primary peritoneal cancer that stopped responding to platinum chemotherapy (relapsed within 6 months) - You have already received bevacizumab as a prior treatment - You have at least one measurable tumor on scans - You have received at least a certain number of prior treatment regimens **You may NOT be eligible if...** - You have not received bevacizumab previously - Your cancer is not the high-grade epithelial type - Your overall health or organ function does not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine

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

BIOLOGICALN-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).

BIOLOGICALM-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.


Locations(2)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, United States

Hoag

Newport Beach, California, United States

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NCT06710288


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