drugset / Trial / NCT02414269
Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin
Phase 1/2
Active not recruiting
113 enrolled
Memorial Sloan Kettering Cancer Center
Bellicum Pharmaceuticals · collabUnited States Department of Defense · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this Phase I study is to test the safety of different doses of specially prepared immune cells (called "T cells") collected from blood. The Investigators want to find a safe dose of these modified T cells for patients who have malignant pleural disease. They want to find out what effects these T cells have on the patient and the cancer (MPD). Phase 2 part of the study, the investigators will test the dose in combination with another drug, pembrolizumab, to see what effects the study treatment has on malignant pleural mesothelioma.
Timeline
- Start
- 2015-05
- Primary completion
- 2026-04-30
- Completion
- 2026-04-30
Publications
- Barr T, Ma S, Li Z, Yu J. Recent advances and remaining challenges in lung cancer therapy. Chin Med J (Engl). 2024 Mar 5;137(5):533-546. doi: 10.1097/CM9.0000000000002991. Epub 2024 Feb 7.
- Ghosn M, Cheema W, Zhu A, Livschitz J, Maybody M, Boas FE, Santos E, Kim D, Beattie JA, Offin M, Rusch VW, Zauderer MG, Adusumilli PS, Solomon SB. Image-guided interventional radiological delivery of chimeric antigen receptor (CAR) T cells for pleural malignancies in a phase I/II clinical trial. Lung Cancer. 2022 Mar;165:1-9. doi: 10.1016/j.lungcan.2022.01.003. Epub 2022 Jan 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | iCasp9M28z T cell infusions | Cell therapy | 6e+07 cells/kg | Intrathecal |
| Background | Cyclophosphamide | Other / unclassified | 1500 mg/m2 | Intravenous |