Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma (NCT04577326) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma
United States14 participantsStarted 2020-09-30
Plain-language summary
This study will test the safety of MSLN-targeted CAR-T cells at different doses to find the safest dose to give to people with MPM. The researchers want to see what effects, if any, the study treatment has on people with this type of cancer. This study is the first time that an MSLN-targeted CAR-T cell treatment with an anti-PD1 component is being given to people.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged ≥18 years
✓. Karnofsky performance status ≥70%
✓. Pathologically confirmed MPM
✓. Epithelioid or biphasic histologic diagnosis provided that ≥10% of the tumor expresses MSLN by IHC analysis
✓. Patients with peritoneal mesothelioma with pleural involvement are eligible only if there is radiographic and pathologic confirmation of mesothelioma in the pleural cavity and ≥10% of the tumor expresses MSLN by IHC analysis.
✓. Previously treated with at least 1 treatment regimen
✓. Measurable or evaluable disease (disease is considered evaluable but not measurable if it does not meet the eligibility criteria for mRECIST but is a manifestation of malignancy that can be followed qualitatively as an indicator of disease progression or treatment response)
✓. Chemotherapy, targeted therapy, or radiotherapy must be completed at least 7 days before leukapheresis.
Exclusion criteria
✕. Patients receiving therapy for concurrent active malignancy
✕. Patients who received prior CAR T-cell therapy
✕. Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible if all the following criteria are met:
✕. Presence of measurable or evaluable disease outside of the CNS
✕. Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between completion of CNSdirected therapy and the screening radiographic study
✕. Completion of radiotherapy ≥8 weeks before the screening radiographic study
✕. Discontinuation of corticosteroids and anticonvulsants ≥4 weeks before the screening radiographic study