Actively Recruiting
Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer
Led by Dana-Farber Cancer Institute · Updated on 2026-03-04
18
Participants Needed
2
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy in recurrent, high grade ovarian cancer (HGOC). Names of the study therapies involved in this study are: CIML NK (cellular therapy) Interleukin-2 (IL-2)
CONDITIONS
Official Title
Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically or cytologically confirmed recurrent epithelial ovarian cancer, including high grade serous, high grade endometrioid, and clear cell ovarian carcinoma.
- Participants must have measurable cancer based on RECIST 1.1 criteria.
- Must have received at least one line of prior systemic therapy and be classified as platinum resistant or intolerant.
- Participants with BRCA1 or BRCA2 mutations must have had prior PARP inhibitor therapy.
- Age between 18 and less than 85 years.
- ECOG performance status of 0 or 1.
- Adequate organ and marrow function including neutrophil count ≥1,000/mcL, platelets ≥75,000/mcL, liver enzymes ≤3x institutional upper limit, total bilirubin ≤1.5x ULN (or <3x ULN with certain exceptions), serum creatinine ≤2.0 mg/dL or GFR ≥40 mL/min/1.73 m2, oxygen saturation ≥90% on room air, and left ventricular ejection fraction ≥40%.
- No laboratory evidence of ongoing hemolysis.
- Prior or concurrent malignancies allowed if they do not interfere with safety or efficacy assessments.
- Cardiac function assessment showing New York Heart Association Functional Classification class 2B or better.
- Ability to tolerate placement of an intraperitoneal port for NK cell infusion.
- Ability to understand and willing to sign informed consent.
- Women of childbearing potential and men must agree to use adequate contraception during the study.
You will not qualify if you...
- Anti-tumor chemotherapy or investigational agents within two weeks prior to NK cell infusion (six weeks for certain drugs) or immunotherapy within six weeks prior, or not recovered from prior adverse events.
- Bowel obstruction within last three months or high risk for bowel obstruction or dependence on intravenous fluids.
- Receiving other investigational agents.
- Solid organ transplant recipients.
- Additional malignancy that is progressing or requires active treatment, or history of other malignancy within two years, with some exceptions.
- History of severe allergic reactions to similar compounds.
- Prior immune checkpoint inhibitor therapy with severe or prolonged immune-related toxicity.
- History of autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis, systemic sclerosis, lupus, autoimmune vasculitis, or motor neuropathy considered autoimmune (Hashimoto thyroiditis allowed).
- Systemic corticosteroid therapy greater than 10 mg prednisone (or equivalent) within four weeks prior to NK cell infusion.
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance.
- Pregnant or breastfeeding women.
- HIV positive status.
- Active uncontrolled hepatitis B or C.
- Known non-infectious pneumonitis or history of interstitial lung disease.
- Receipt of live vaccine within 30 days of study treatment.
- Anaphylactic reactions to murine-based antibody therapy or iron dextran.
- Prior history of grade 2 or higher hemolytic anemia.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
D
DFCI Clinical Trials Hotline DFCI Clinical Trials Hotline
CONTACT
R
Rebecca Porter, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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