Table 2.
Ongoing and completed trials for T-cell therapy in mesothelioma.
| NCT nr. | Study type | Antigen | Stimulatory signal | Additional therapy | Current status | Delivery method | Cancer type | n | Outcome | References |
|---|---|---|---|---|---|---|---|---|---|---|
| NCT01722149 | Phase 1 | FAP | CD28 | Neoadjuvant chemotherapy | Completed, no results posted | i.p. | MPM | 3* | Pos: tAE: none | (82) |
| NCT01355965 | Phase 1 | MSLN | 4-1BB | ns | Completed, no results posted | i.v. | MPM, pancreatic cancer | 18* | Pos: (only reported outcomes of 2 patients): tAE: none | (83) |
| NCT01583686 | Phase 1/2 | MSLN | ns | Fludarabine, cyclophosphamide, aldesleukin | Terminated | i.v. | MSLN expressing tumors | 15* | Terminated due to slow accrual (14/15 patients had a BOR of PD) | - |
| NCT02159716 | Phase 1 | MSLN | 4-1BB | Cyclophosphamide | Completed, no results posted | i.v. | MPM, pancreatic cancer and ovarian cancer | 15* | Pos: tAE: 1 grade IV tox 11SD, 4PD | (84) |
| NCT02580747 | Phase 1 | MSLN | ns | ns | Unknown | ns | MSLN expressing tumors | 20 | - | |
| NCT02930993 | Phase 1 | MSLN | ns | Cyclophosphamide | Unknown | i.v. | MSLN expressing tumors | 20 | - | |
| NCT03638206 | Phase 1 | MSLN | ns | Fludarabine, cyclophosphamide | Recruiting | ns | MPM | ns | - | |
| NCT03054298 | Phase 1 | MSLN | ns | cyclophosphamide | Recruiting | i.v./i.p. | MSLN expressing tumors | 30 | - | |
| NCT02408016 | Phase 1 | WT-1 | ns | Cyclophosphamide, surgery IL-2 | Active, not recruiting | i.v. | MPM/NSCLC | 20 | - | |
| NCT03615313 | Phase 1/2 | MSLN | PD-1 excreting CAR T cells | Fludarabine, cyclophosphamide | Recruiting | i.v. | MSLN expressing tumors | 50 | - | |
| NCT02414269 | Phase 1/2 | MSLN | CD28 | Cyclophosphamide, pembrolizumab | Recruiting | i.p. | MPM | 179 21*** | Pos: tAE: no grade III/IV tox 2 CR, 5 PR, 4 SD, 10 PD | (85) |
| NCT03907852 | Phase 1/2 | MSLN | TRuC (novel T cell engenering platform) | Cyclophosphamide, pembrolizumab, fudarabine | Recruiting | ns | MSLN expressing tumors | 70 | - | |
| NCT03925893 | Phase 2 | - | TIL | Fludarabine, cyclophosphamide, aldesleukin | Recruiting | i.v. | Solid tumors | 10 | - | |
| NCT02414945 | Phase 1/2 | - | TIL | Fludarabine, cyclophosphmide, IL-2 | Recruiting | i.v. | MPM | 10 | - |
FAP, fibroblast activation protein; MSLN, mesothelin; WT-1, Wilms Tumor 1; MPM, malignant pleural mesothelioma; n, expected number of patients; *actual enrollment; ***21 patients were enrolled in the phase I trial which was reported at the AACR 2019; TRuC, T Cell Receptor Fusion Constructs; ns, not specified; TILs, tumor infiltrating lymphocytes; tAE, treatment related adverse event; i.p., intrapleural; i.v., intravenous; pos, positive; BOR, best overall response; PD, progressive disease; tox, toxicity; SD, stable disease; CR, complete response; PR, partial response.