TCR Genetically Engineered PBMC and PBSC After Melphalan Conditioning Regimen in Treating Participants With Relapsed and Refractory Multiple Myeloma
Summary
This phase I trial studies the side effects of NY-ESO-1 TCR engineered peripheral blood mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after melphalan conditioning regimen in treating participants with multiple myeloma that has come back or does not respond to treatment. The melphalan conditioning chemotherapy makes room in the patient?s bone marrow for new blood cells (PBMC) and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR PBMC and stem cells after the conditioning chemotherapy is intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer. Giving NY-ESO-1 TCR PBMC and PBSC after melphalan may work better at treating multiple myeloma.
Timeline
- Start
- 2018-07-10
- Primary completion
- 2019-06-25
- Completion
- 2019-06-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LV-NYESO TCR /sr39TK PBSC | Cell therapy | — | Intravenous |
| Subject | RV-NYESO TCR PBMC | Cell therapy | — | Intravenous |
| Background | Lenalidomide | Other / unclassified | — | Oral |
| Background | Melphalan | Small molecule | — | Intravenous |
| Background | Plerixafor | Small molecule | — | Subcutaneous |
| Background | aldesleukin | Protein / enzyme biologic | — | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |