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NCT06710288 · ClinicalTrials.gov registry record · Phase 2

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 study of Platinum-resistant Ovarian Cancer, sponsored by ImmunityBio.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
2
Study locations

NCT06710288 is a Phase 2 study of Platinum-resistant Ovarian Cancer that is actively recruiting participants, run by ImmunityBio. The registered enrollment target is 20 participants, below the 185-participant average among 17 other Platinum-resistant Ovarian Cancer trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT06710288, a Phase 2 study of Platinum-resistant Ovarian Cancer, is actively recruiting participants, sponsored by ImmunityBio.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
2
Study locations

Study 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.

Conditions Studied

Platinum-resistant Ovarian Cancer

Interventions

  • DRUG Gemcitabine
  • BIOLOGICAL N-803
  • BIOLOGICAL M-CENK

Study Locations (2)

California

  • Chan Soon-Shiong Institute for Medicine - El Segundo
  • Hoag - Newport Beach

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-11-06
Est. Completion 2027-05
Phase Phase 2

Sponsor

ImmunityBio

46 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06710288

The ClinicalTrials.gov registry entry for NCT06710288 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 185-participant average among 17 other Platinum-resistant Ovarian Cancer trials with a reported enrollment target (89% lower). The listed sponsor is ImmunityBio, which has 46 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Platinum-resistant Ovarian Cancer appearing as the primary indexed condition, and to 3 interventions - of which Gemcitabine is the first listed.

NCT06710288 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT06710288 about?

NCT06710288 is a clinical study titled "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 (S...

What is the current status of trial NCT06710288?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-11-06. Estimated completion is 2027-05.

What conditions does trial NCT06710288 study?

This clinical trial studies the following conditions: Platinum-resistant Ovarian Cancer.

What interventions are being tested in trial NCT06710288?

The interventions under investigation include: Gemcitabine (DRUG), N-803 (BIOLOGICAL), M-CENK (BIOLOGICAL).

Who is sponsoring clinical trial NCT06710288?

This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06710288 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.