Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04577326 | Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma | PHASE1 | ACTIVE NOT_RECRUITING | 14 | — | — | Sep 30, 2020 | Sep 30, 2026 | Jul 25, 2025 | 1 | United States |
CTCAE v5.0 will be used to assess the severity of all treatment emerging toxicities/adverse events regardless
| Arm | Type | Description |
|---|---|---|
| Engineered Autologous T Cells | EXPERIMENTAL | Following eligibility screening and enrollment, patients will undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMCs), to enable generation of M28z1XXPD1DNR. Following successful M28z1XXPD1DNR CAR T-cell manufacturing, patients will be reevaluated for eligibility. A preconditioning regimen of one dose of intravenous (IV) cyclophosphamide 1.5 g/m2 will be administered 2-7 days before the infusion. A single dose of M28z1XXPD1DNR CAR T cells will be instilled into the pleural cavity via a pleural catheter or through an interventional radiology-guided needle. All patients will be monitored in the hospital for a minimum of 48 h following the administration of CAR T cells. |
| Name | Type | Description |
|---|---|---|
| cyclophosphamide | DRUG | A preconditioning regimen of one dose of intravenous (IV) cyclophosphamide 1.5 g/m\^2 will be administered 2-7 days before the infusion. |
| CAR T cells | BIOLOGICAL | A single dose of M28z1XXPD1DNR CAR T cells will be instilled into the pleural cavity via a pleural catheter or through an interventional radiology-guided needle. Cohorts of 3 patients will be treated at each dose level, up to a maximum of 3 x 10\^7 T cells/kg or until the MTD has been reached. |
Inclusion Criteria: 1. Aged ≥18 years 2. Karnofsky performance status ≥70% 3. Pathologically confirmed MPM 1. Epithelioid or biphasic histologic diagnosis provided that ≥10% of the tumor expresses MSLN by IHC analysis 2. Patients with peritoneal mesothelioma with pleural involvement are elig...