Health TrialsbyHealthPanel

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

ConditionMalignant Pleural Mesotheliomas
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biotech

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EB-MF-CAR-NK-01

    Biological/Vaccine

    Example investigational product: donor-derived allogeneic NK cells engineered to recognize both MSLN-positive tumor cells and FAPpositive stromal elements, manufactured under GMP

  • Fludarabine

    Drug

    Lymphodepleting chemotherapy administered before CAR-NK infusion

  • Cyclophosphamide

    Drug

    Lymphodepleting chemotherapy administered before CAR-NK infusion.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Pleural Mesothelioma CohortExperimental treatment 3 interventions
Group B: Peritoneal Mesothelioma CohortExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs) after first CAR-NK infusion

Time frame
28 days
2

ncidence and severity of treatment-emergent adverse events (TEAEs)

ncidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), cytokine release syndrome, neurotoxicity, pleuritis/peritonitis, infusion reactions, and on-target/off-tumor toxicities graded by CTCAE v5.0 and ASTCT crit

Time frame
12 months
3

Determination of recommended phase 2 dose and schedule (RP2D/RP2S)

Time frame
6 months

Secondary outcomes

1

Objective response rate (ORR) by modified RECIST for the pleural cohort and RECIST 1.1 for the peritoneal cohort

Time frame
12 months
2

Disease control rate (DCR) at 12 weeks

Time frame
12 weeks
3

Duration of response (DOR)

Time frame
24 months
4

Progression-free survival (PFS)

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
Apply now