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Immune cell cocktail takes on Platinum-Resistant ovarian cancer

NCT ID NCT06710288

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This phase 2 trial tests a new approach for people with platinum-resistant high-grade ovarian cancer, a type that no longer responds to standard chemotherapy. Up to 20 participants will receive their own immune cells (M-CENK) that have been trained to fight cancer, along with an immune booster (N-803) and the chemotherapy drug gemcitabine. The goal is to see if this combination can shrink tumors or slow the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
M-CENK (memory cytokine enriched natural killer cells), N-803 (IL-15 superagonist), and gemcitabine
What this could lead to
If it works, this could offer a new treatment option for people with ovarian cancer that no longer responds to platinum-based chemotherapy.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The combination therapy may cause side effects and may not shrink tumors or extend survival.
Why investors are watching

ImmunityBio is running a small phase 2 trial testing its cell therapy M-CENK plus the immune booster N-803 alongside the chemotherapy gemcitabine in 20 patients with platinum-resistant ovarian cancer. For a small company, this readout matters because it tests whether its experimental combination can control a cancer that has stopped responding to standard platinum drugs, a hard-to-treat setting where any sign of benefit stands out. A clear result could validate the company's platform and support further development, while a weak result would leave it without a key clinical catalyst.

If it works: If the trial shows the combination is safe and controls the disease in a meaningful share of patients, ImmunityBio could advance the regimen into a larger study or attract partnership interest. Positive efficacy data in platinum-resistant ovarian cancer would give the company a new, credible clinical story to tell investors and regulators.

If it fails: Phase 2 trials in this patient group often fail, and with only 20 participants, a few poor outcomes could sink the readout. A failure or delay would likely set back the program and pressure the stock, since the company's value depends heavily on this and similar early-stage results.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥18 years and \<85 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Participants must be appropriate for single-agent therapy as the next line of therapy, as determined by the Investigator. 4. Participants must have received prior treatment with bevacizumab. 5. 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. 6. Must have at least one lesion that meets the definition of measurable disease defined by RECIST v1.1 criteria. 7. 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. 8. Participants with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment. 9. 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. 10. Must be able to sit or recline with limited movement for approximately 6 hours during apheresis procedure. 11. Participants must have been previously tested for FRα. If the test result was positive, they must have been offered treatment with mirvetuximab soravtansine-gynx. 12. 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. 13. Eastern cooperative oncology group (ECOG) performance status of ≤ 1. 14. Major surgery must be completed and recovered at least 4 weeks prior to the first dose of study treatment. 15. 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 16. 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. 17. 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. 18. Expected survival \> 16 weeks. 19. Stated willingness to comply with study procedures. 20. 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. Exclusion Criteria: In order to participate in the study, participants must not meet any of the following criteria: 1. Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low grade or borderline ovarian tumor. 2. Distant metastasis outside of the abdominopelvic cavity (e.g., central nervous system, pulmonary, osseous, etc.). 3. 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. 4. Current bowel obstruction, history of bowel obstruction, or high risk for bowel obstruction (in the opinion of the investigator). 5. Poor oral intake requiring parenteral nutrition or dependence on intravenous fluids. 6. Presence or history of ascites. 7. Receiving any other investigational agents. 8. Solid organ transplant (allograft) recipients. 9. 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. 10. Known hypersensitivity or anaphylaxis to sulfa-containing study medication(s). 11. Known allergy to dimethyl sulfoxide (DMSO). 12. 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. 13. 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. 14. 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. 15. 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. 16. 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. 17. 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. 18. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chan Soon-Shiong Institute for Medicine

    RECRUITING

    El Segundo, California, 90245, United States

  • Hoag

    RECRUITING

    Newport Beach, California, 92663, United States

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