Actively Recruiting
A Phase 1/2, Open-Label Study of Dual-Targeting CAR-NK Cells Against Mesothelin, Folate Receptor Alpha, and MUC16 in Recurrent or Refractory High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Led by Beijing Biotech · Updated on 2026-03-18
36
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells for participants with recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer. This Phase 1/2 study aims to assess the safety, tolerability, and early anti-tumor activity of CAR-NK cells matched to the tumor's expression of Mesothelin, Folate Receptor alpha, and MUC16 to reduce antigen escape. The study is sponsored by Beijing Biotech and involves biomarker assignment to guide treatment selection. The study has two parts: dose escalation using a 3+3 design to identify a recommended Phase 2 dose, followed by dose expansion to explore efficacy and biomarkers. Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, then CAR-NK cells administered mainly intraperitoneally via an implanted port, with optional intravenous dosing. Three CAR-NK products target different pairs of tumor antigens: MSLN/FRalpha, MSLN/MUC16, or FRalpha/MUC16, assigned based on tumor antigen expression. Participants undergo tumor tissue testing for target expression and are monitored closely for side effects such as cytokine release syndrome, neurotoxicity, infections, and blood count changes. Disease response is assessed regularly using RECIST criteria and CA 125 tumor marker trends. Safety is followed for 12 months, and survival is tracked for up to 24 months, with possible long-term monitoring for gene-modified cell therapy safety. The study includes various laboratory tests and clinical evaluations throughout participation.
CONDITIONS
Brief Title
Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (high-grade serous preferred)
- Recurrent or refractory disease after at least 2 prior systemic treatment lines including platinum-based therapy unless contraindicated
- Measurable disease per RECIST v1.1
- Tumor expresses at least two targets: Mesothelin (MSLN), Folate Receptor alpha (FOLR1), MUC16 (CA 125) above protocol-defined threshold
- ECOG performance status 0-1
- Adequate organ function including ANC ≥ 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L, hemoglobin ≥ 8 g/dL, AST/ALT ≤ 3 x ULN (≤ 5 x ULN with liver metastases), total bilirubin ≤ 1.5 x ULN, creatinine clearance ≥ 50 mL/min
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception through 12 months post-infusion
- Ability to comply with study procedures and follow-up schedule
- Written informed consent
You will not qualify if you...
- Prior gene-modified cellular therapy within 6 months or any prior therapy targeting the same antigens
- Active central nervous system metastases or carcinomatous meningitis needing therapy
- Uncontrolled infections including active tuberculosis or significant viral infections
- Known HIV infection with uncontrolled viremia; active hepatitis B or C with detectable viral load
- Significant cardiovascular disease such as recent heart attack, uncontrolled arrhythmia, or severe heart failure
- Active autoimmune disease requiring systemic immunosuppression within 30 days (except physiologic steroid replacement)
- Concurrent anti-cancer therapy not permitted within protocol-defined washout period
- Major surgery within 4 weeks prior to lymphodepletion (minor procedures allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - A few days prior to CAR-NK cell administration
Participants receive lymphodepleting chemotherapy to prepare for CAR-NK cell infusion.
1 to 2 visits for chemotherapy administration
Duration - Up to 28 days for initial dose-limiting toxicity assessment, with possible continued treatment per protocol
Participants receive dual-target CAR-NK cells administered intraperitoneally via an implanted port, with optional intravenous dosing as per investigator judgment.
Several visits for CAR-NK cell administration and monitoring
Duration - Up to 24 months
Participants are monitored for adverse events, disease response, and survival outcomes following CAR-NK cell treatment.
Regular visits for safety assessments and response evaluations, including monitoring for cytokine release syndrome, neurotoxicity, and other adverse events
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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