NCT07510815 Dual-Target MSLN/FAP CAR-NK Cells for Pleural and Peritoneal Mesothelioma

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 36 participants in total. It began in 2026-03-02 with a primary completion date of 2027-03-14.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Age 18 to 75 years at the time of consent. * Histologically confirmed malignant pleural mesothelioma or malignant peritoneal mesothelioma; unresectable, recurrent, metastatic, or refractory disease. * Prior receipt of at least one standard systemic regimen for mesothelioma, or documented ineligibility, intolerance, or refusal of standard therapy considered reasonable by the investigator. * Central biomarker confirmation of MSLN-positive tumor cells and FAP-positive tumorassociated stroma at protocol-defined thresholds. * At least one measurable or evaluable lesion by cohort-appropriate imaging criteria. * ECOG performance status 0 to 1. * Adequate bone marrow, renal, hepatic, coagulation, cardiac, and pulmonary function to undergo lymphodepletion and locoregional cell infusion. * Safe procedural access for intrapleural or intraperitoneal administration, as applicable. * Recovery to Grade 1 or better from prior anticancer therapy toxicities, except alopecia, stable neuropathy, or controlled endocrine replacement. * Life expectancy of at least 12 weeks. * Negative pregnancy test for participants of childbearing potential and agreement to use protocoldefined contraception. * Ability to understand and sign informed consent Exclusion Criteria: * Active or untreated CNS metastases, leptomeningeal disease, or uncontrolled seizures. * Uncontrolled bacterial, fungal, viral, or mycobacterial infection, including empyema, active pleural space infection, peritonitis, or uncontrolled HBV, HCV, or HIV infection. * Autoimmune disease requiring systemic immunosuppression within 14 days before lymphodepletion, or prednisone equivalent greater than 10 mg/day. * Clinically significant cardiovascular disease, uncontrolled arrhythmia, unstable angina, recent myocardial infarction, or other condition judged to increase infusion risk. * Severe interstitial lung disease, baseline oxygen requirement, or other pulmonary compromise making pleural therapy unsafe. * Bowel perforation risk, uncontrolled bowel obstruction, uncontrolled ascites, or any abdominal condition that makes intraperitoneal infusion unsafe in the peritoneal cohort. * Prior gene-modified cell therapy directed against MSLN or FAP within the protocol washout period, or active graft-versus-host disease after prior transplant. * Need for concurrent systemic anticancer therapy other than protocol-permitted supportive care. * Pregnancy or breastfeeding. * Any medical, psychiatric, social, or logistical condition that, in the investigator's judgment, could compromise safety, compliance, or interpretability of study results.

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