A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-… (NCT06710288) | Clinical Trial Compass
RecruitingPhase 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
United States20 participantsStarted 2024-11-06
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate Progression Free Survival (PFS)
Timeframe: Cycle 1 Day 1 through End of Study, up to 2 years
2
Evaluate Overall Survival (OS)
Timeframe: Cycle 1 Day 1 through End of Study, up to 2 years
3
Evaluate Objective Response Rate (ORR)
Timeframe: Cycle 1 Day 1 through End of Study, up to 2 years
4
Evaluate Duration of Response (DOR)
Timeframe: From time of first response to the date of disease progression or death, up to 2 years
5
Evaluate Disease Control Rate (DCR)
Timeframe: 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.
Timeframe: 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.
. 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 with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment.
Exclusion 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.
. Presence or history of ascites.
. Receiving any other investigational agents.
. Solid organ transplant (allograft) recipients.
Timeframe: Cycle 1 Day 1 through End of Study, up to 2 years