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Platinum-resistant Ovarian CancerPhase 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 study testing Gemcitabine, N-803 and M-CENK in people with Platinum-resistant Ovarian Cancer, run by ImmunityBio, Inc. at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years, women only
Conditions the study is for
Platinum-resistant Ovarian Cancer
What is being tested?
Gemcitabine, N-803 and M-CENK
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
6 Nov 2024to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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 Committee (IEC) guidelines.
  • 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.
  • Confirmed diagnosis of platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal or fallopian tube. Platinum-resistant is defined as a relapse within 6 months of receiving 1 to 3 platinum-based chemotherapy regimens.
  • Must have at least one lesion that meets the definition of measurable disease defined by RECIST v1.1 criteria.
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  • Must have received at least one but no more than three prior systemic lines of anticancer therapy and had progressive disease (PD) while receiving or immediately after receiving the previous therapy. Progression will be calculated from the date of the last administered dose of platinum based therapy to the date of radiographic imaging that showed evidence of progression.
  • Participants who had received one line of platinum-based therapy must have received at least four cycles of their initial platinum-containing regimen, had a response (complete or partial), and then had PD between 3 and 6 months after their last dose.
  • Participants who had previously received two or three lines of platinum-based therapy must have had PD while receiving the therapy or within 6 months after the last dose.
  • Participants with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment.
  • Must have adequate peripheral venous access on both arms, or be willing to have temporary vascular access placed for apheresis collection, if deemed necessary by the Investigator.
  • Must be able to sit or recline with limited movement for approximately 6 hours during apheresis procedure.
  • Participants must have been previously tested for FRα. If the test result was positive, they must have been offered treatment with mirvetuximab soravtansine-gynx.
  • Agreement to practice effective contraception for female participants of childbearing potential. Female participants of childbearing potential must agree to use effective contraception for up to 7 months after completion of study treatment. Effective contraception includes surgical sterilization (eg, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, diaphragm), intrauterine devices (IUDs), and hormonal therapy.
  • Eastern cooperative oncology group (ECOG) performance status of ≤ 1.
  • Major surgery must be completed and recovered at least 4 weeks prior to the first dose of study treatment.
  • Participants must meet the following organ and marrow function as defined below:
  • Absolute neutrophil count ≥ 1,000/mm3
  • Platelets ≥ 100,000/mm3
  • AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
  • Total bilirubin ≤1.5 × institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then < 3 × ULN)
  • Albumin ≥ 3.0 g/dL
  • Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min/1.73 m2 by Cockcroft-Gault Formula (Appendix C.1)
  • Oxygen saturation: ≥ 90% on room air
  • Participants with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification (Appendix B.2). To be eligible for this trial, participants should be class 2B or better.
  • Expected survival > 16 weeks.
  • Stated willingness to comply with study procedures.
  • Able to attend required study visits and return for adequate follow-up, as required by this protocol.
  • All inclusion criteria must be answered "yes" for a participant to participate in the trial.

Who cannot join

  • In order to participate in the study, participants must not meet any of the following criteria:
  • Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low grade or borderline ovarian tumor.
  • Distant metastasis outside of the abdominopelvic cavity (e.g., central nervous system, pulmonary, osseous, etc.).
  • Have had anti-tumor chemotherapy or other investigational agents within 2 weeks prior to M-CENK cell infusion, or immunotherapy within 4 weeks prior, or those who have not recovered from adverse events due to agents administered more than two weeks prior. The intent of the language is to ensure that anti-tumor chemotherapy or other investigational agents are not administered to participants within the specified window since they can potentially affect M-CENK cell activity. Therefore, the washout period is defined by time from NK cell infusion and not patient enrollment. During eligibility confirmation from the study team is requested to confirm that according to the planned M-CENK cell dosing schedule, the washout period should be completed, based on each drug class.
  • Current bowel obstruction, history of bowel obstruction, or high risk for bowel obstruction (in the opinion of the investigator).
  • Poor oral intake requiring parenteral nutrition or dependence on intravenous fluids.
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  • Presence or history of ascites.
  • Receiving any other investigational agents.
  • Solid organ transplant (allograft) recipients.
  • Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study treatment with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other non-invasive or indolent malignancy, or cancers from which the patient has been disease-free for > 1 year after treatment with curative intent.
  • Known hypersensitivity or anaphylaxis to sulfa-containing study medication(s).
  • Known allergy to dimethyl sulfoxide (DMSO).
  • Prior history of immune-related toxicity during immune therapy that resulted in permanent discontinuation of therapy (as recommended per product label or consensus guidelines) OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well-controlled on replacement hormones) are excluded.
  • Autoimmune disease: history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [Wegener's granulomatosis]) and motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis). participants with Hashimoto thyroiditis are eligible.
  • Systemic corticosteroid therapy (> 10 mg of prednisone or equivalent dose of systemic steroids for at least 4 weeks prior to NK cell infusion). The intent of this language is to ensure that systemic steroids are not administered to participants within the specified window since this can potentially affect NK cell activity. Therefore, the washout period is defined by time from NK cell infusion and not patient enrollment. During eligibility confirmation the study team is requested to confirm that according to the planned NK cell dosing schedule, the washout period should be completed.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  • Active uncontrolled hepatitis B or C are ineligible as they are at high-risk of lethal treatment-related hepatotoxicity in the setting of marrow suppression. Known non-infectious pneumonitis or any history of interstitial lung disease.
  • Receipt of a live vaccine within 30 days of start of study treatment. During eligibility confirmation the study team is requested to confirm that according to the planned NK cell dosing schedule, the washout period should be completed.
  • All exclusion criteria must be answered "no" for a participant to participate in the trial.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jayson Garmizo contact

310-912-2230

jayson.garmizo@immunitybio.com

Kamin Personett contact

Kamin.Personett@Immunitybio.com

United States2 sites, 2 recruiting

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, California, 90245

    Jacqui Parnin, 1-213-266-5604, Jacqueline.Parnin@cssifm.org

    Jaya (Mini) Gill, 213-266-5639, Jaya.Gill@cssifm.org

    Recruiting

  • Hoag

    Newport Beach, California, 92663

    Tiffany Beck, M.D., MPH, FACOG, 949-642-1361, tiffany.beck@hoag.org

    Ana Navarrete, ana.navarrete@hoag.org

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Being tested
Gemcitabine, N-803, M-CENK
Keywords
high grade ovarian cancer, M-CENK, N-803

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called gemcitabine hydrocholoride, Gemzar

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

  • N-803Biological

    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-CENKBiological

    Also called Autologous Memory Cytokine Enriched Natural Killer

    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 groups in NCT06710288
Study groupRoleWhat they receive
All subjectsExperimentalGemcitabine plus M-CENK plus N-803
Receives: Drug: Gemcitabine; Biological: N-803; Biological: M-CENK

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate Progression Free Survival (PFS)

    Measured by RECIST v1.1 and iRECIST

    Measured: Cycle 1 Day 1 through End of Study, up to 2 years

  2. Evaluate Overall Survival (OS)

    Measured: Cycle 1 Day 1 through End of Study, up to 2 years

  3. Evaluate Objective Response Rate (ORR)

    Measured by RECIST v1.1 and iRECIST

    Measured: Cycle 1 Day 1 through End of Study, up to 2 years

  4. Evaluate Duration of Response (DOR)

    Measured by RECIST v1.1 and iRECIST

    Measured: From time of first response to the date of disease progression or death, up to 2 years

  5. Evaluate Disease Control Rate (DCR)

    Measured by RECIST v1.1 and iRECIST

    Measured: Cycle 1 Day 1 through End of Study, up to 2 years

  6. Evaluate the time to progression or death on the next line of treatment (PFS2) of participants receiving M-CENK adoptive cell therapy and N-803 in combination with gemcitabine.

    Measured by RECIST v1.1 and iRECIST and survival status

    Measured: Cycle 1 Day 1 through End of Study, up to 2 years

  7. Evaluate the CA-125 response rate (RR) per Gynecologic Cancer Intergroup (GCIC) CA-125 criteria.

    Measured by the CA-125 result

    Measured: Cycle 1 Day 1 through End of Study, up to 2 years

Secondary outcomes (8)

  1. Safety: Evaluate adverse events

    Measured: Apheresis to 30 days after the last dose of study treatment or the end of treatment visit, up to 13 months

  2. Safety: Incidence of clinically significant changes in comprehensive metabolic panel (CMP)

    Standard blood chemistry panel made up of 14 separate chemistry measurements so can detect a range of abnormalities in blood sugar, nutrient balance, and liver and kidney health. Each clinical site will use their local laboratory upper limit of normal (ULN) range. The treating investigator will assess each result composing the CMP and determine if each result is within expected normal range or outside of the expected normal range.

    Measured: Screening through Follow-up, up to 2 years

  3. Safety: Incidence of clinically significant changes in Hematology blood panel

    Blood test checking the levels for White Blood Cell, Red Blood Cell, Platelets, Hemoglobin, Hematocrit, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils per unit volume. Each clinical site will use their local laboratory upper limit of normal (ULN) range. The treating investigator will assess each component of the Hematology panel and determine if each result is within expected normal range or outside of the expected normal range.

    Measured: Screening through Follow-up, up to 2 years

  4. Safety: Incidence of clinically significant changes in Temperature

    Temperature measured in either Fahrenheit or Celsius and for any abnormalities. Each site will assess to determine if temperature is within expected normal range or outside of the expected normal range.

    Measured: Screening through Follow-up, up to 2 years

  5. Safety: Incidence of clinically significant changes in Heart Rate

    Heart rate measured in beats/minute. Each site will assess to determine if heart rate is within expected normal range or outside of the expected normal range.

    Measured: Screening through Follow-up, up to 2 years

  6. Safety: Incidence of clinically significant changes in Respiratory Rate

    Respiratory rate measured in breaths/minute. Each site will assess to determine if respiratory rate is within expected normal range or outside of the expected normal range.

    Measured: Screening through Follow-up, up to 2 years

  7. Safety: Incidence of clinically significant changes in Blood Pressure

    Blood pressure measured in Systolic and Diastolic mmHg. Each site will assess to determine if blood pressure is within expected normal range or outside of the expected normal range.

    Measured: Screening through Follow-up, up to 2 years

  8. Safety: Incidence of clinically significant changes in Oxygen Saturation

    A pulse oximeter measures oxygen saturation as a percentage. Determines the ratio of the current levels of oxygenated hemoglobin to deoxygenated hemoglobin. Each site will assess to determine if oxygen saturation is within expected normal range or outside of the expected normal range.

    Measured: Screening through Follow-up, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start6 Nov 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06710288
Sponsor's protocol ID
ResQ209
Status last verified
Oct 2025
First submitted
5 Nov 2024
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, N-803 and M-CENK in people with Platinum-resistant Ovarian Cancer, run by ImmunityBio, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jayson Garmizo (310-912-2230, jayson.garmizo@immunitybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate Progression Free Survival (PFS) (time frame: Cycle 1 Day 1 through End of Study, up to 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06710288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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