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About
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.
Enrollment
Sex
Ages
Volunteers
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.
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.
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:
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.
Exclusion criteria
In order to participate in the study, participants must not meet any of the following criteria:
All exclusion criteria must be answered "no" for a participant to participate in the trial.
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
Lauren Wilkins; Deana Martz
Data sourced from clinicaltrials.gov
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