Actively Recruiting
Dual-Target MSLN/FAP CAR-NK Cells for Pleural and Peritoneal Mesothelioma
Led by Beijing Biotech · Updated on 2026-04-06
36
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This example study evaluates locoregional allogeneic dual-target mesothelin/FAP CAR-NK cells in adults with unresectable, recurrent, or refractory pleural or peritoneal mesothelioma. Eligible participants must have central confirmation of MSLN-positive tumor cells and FAP-positive tumorassociated stroma. The phase 1 portion defines the recommended phase 2 dose and schedule, and the phase 2 expansion explores preliminary antitumor activity, persistence, and biomarker response in pleural and peritoneal disease cohorts.
CONDITIONS
Official Title
Dual-Target MSLN/FAP CAR-NK Cells for Pleural and Peritoneal Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at the time of consent.
- Histologically confirmed malignant pleural or peritoneal mesothelioma that is unresectable, recurrent, metastatic, or refractory.
- Prior treatment with at least one standard systemic regimen for mesothelioma or documented ineligibility, intolerance, or refusal of standard therapy.
- Central confirmation of MSLN-positive tumor cells and FAP-positive tumor-associated stroma at required levels.
- At least one measurable or evaluable lesion by appropriate imaging.
- ECOG performance status of 0 to 1.
- Adequate bone marrow, kidney, liver, blood clotting, heart, and lung function to safely receive lymphodepletion and cell infusion.
- Safe access for intrapleural or intraperitoneal administration.
- Recovery to Grade 1 or better from prior cancer therapy side effects, except for hair loss, stable neuropathy, or controlled hormone replacement.
- Life expectancy of at least 12 weeks.
- Negative pregnancy test if of childbearing potential and agreement to use contraception.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Active or untreated central nervous system metastases, leptomeningeal disease, or uncontrolled seizures.
- Uncontrolled bacterial, fungal, viral, or mycobacterial infections, including empyema, active pleural infection, peritonitis, or uncontrolled hepatitis B, hepatitis C, or HIV.
- Autoimmune disease requiring systemic immunosuppression within 14 days before lymphodepletion or prednisone equivalent over 10 mg/day.
- Significant heart disease, uncontrolled irregular heartbeat, unstable angina, recent heart attack, or other conditions increasing infusion risk.
- Severe interstitial lung disease, need for oxygen at baseline, or other lung problems making pleural therapy unsafe.
- Risk of bowel perforation, uncontrolled bowel obstruction, uncontrolled ascites, or other abdominal conditions making intraperitoneal infusion unsafe.
- Prior gene-modified cell therapy targeting MSLN or FAP within the washout period or active graft-versus-host disease after transplant.
- Need for other systemic anticancer therapy beyond allowed supportive care.
- Pregnancy or breastfeeding.
- Any medical, psychiatric, social, or logistical condition that may compromise safety, compliance, or study result interpretation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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