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New treatment option for Platinum-resistant Ovarian Cancer
Official title 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
ClinicalTrials.gov ID: NCT06710288
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for platinum-resistant ovarian cancer.
Also referred to as gemcitabine hydrocholoride, Gemzar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85, women only
You may be able to join if
- ≥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...
- 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...
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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 how well it works 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...
- 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 must be answered "yes" for a participant to participate in the trial.
What rules you out
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- El Segundo, California, United States
- Newport Beach, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include El Segundo, California, United States; Newport Beach, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.