Actively Recruiting
A Phase 1/2, Open-Label, Biomarker-Assigned Study of Dual-Targeting CAR-NK Cells Directed Against Mesothelin (MSLN), Folate Receptor Alpha (FRα/FOLR1), and/or MUC16 (CA125) in Patients With Recurrent or Refractory High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Led by Beijing Biotech · Updated on 2026-06-01
36
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and early anti-tumor effects of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in women with recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer. This Phase 1/2 study assigns participants to CAR-NK products based on their tumor's expression of Mesothelin (MSLN), Folate Receptor alpha (FRalpha/FOLR1), and MUC16 (CA 125) to target two of these proteins and reduce the risk of tumor escape. The trial aims to find safe doses and explore preliminary effectiveness and biological markers. The study has two parts: dose escalation to determine safe dosing levels using a 3+3 design within antigen-specific groups, followed by dose expansion at the recommended dose. Before treatment, participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine. CAR-NK cells are then administered, mainly into the abdominal cavity via an implanted port, with optional intravenous dosing. Participants receive supportive care as needed and are monitored closely for side effects such as immune reactions and infections. Participants undergo tumor assessments using imaging criteria (RECIST v1.1) and blood markers like CA 125 at regular intervals. Safety is tracked for 12 months, and survival for up to 24 months, with potential long-term follow-up due to gene therapy regulations. The study includes frequent evaluations of adverse events and treatment responses. Participants are followed closely throughout the study and after treatment to monitor outcomes and safety.
CONDITIONS
Brief Title
Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) pt2
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 a platinum-based regimen unless contraindicated
- Measurable disease per RECIST v1.1
- Tumor expresses at least two of the following targets above protocol-defined threshold: MSLN, FRalpha (FOLR1), MUC16 (CA 125)
- ECOG performance status 0-1
- Adequate organ function: 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 directed to the same target
- Active central nervous system metastases or carcinomatous meningitis requiring therapy
- Uncontrolled infection including active tuberculosis or clinically significant uncontrolled viral infection
- Known HIV infection with uncontrolled viremia; active hepatitis B or C with detectable viral load
- Clinically significant cardiovascular disease such as recent myocardial infarction, uncontrolled arrhythmia, or NYHA Class III/IV heart failure
- Active autoimmune disease requiring systemic immunosuppression within 30 days (physiologic steroid replacement allowed)
- Concurrent anti-cancer therapy not permitted within protocol-defined washout period
- Major surgery within 4 weeks prior to lymphodepletion (except minor procedures)
- Pregnant or breastfeeding
- Any condition increasing risk or interfering with study interpretation as judged by investigator
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 visit (in-person)
Duration - 28 days
Participants receive lymphodepleting chemotherapy followed by dual-target CAR-NK cell therapy administered intraperitoneally via an implanted port, with optional intravenous dosing. Participants are monitored closely for side effects including cytokine release syndrome, neurotoxicity, cytopenias, infections, and other adverse events.
Multiple visits during treatment period for administration and monitoring
Duration - Up to 24 months
Participants are followed for adverse events through 12 months and for survival up to 24 months after treatment. Long-term safety monitoring for gene-modified cell therapy may be required.
Regular visits for adverse event monitoring and survival follow-up
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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