Full TitleProtocol H125001: An Open-Label Phase 1/2 Study of JCARH125, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects with Relapsed and/or Refractory Multiple Myeloma
CAR T-cell therapy is a form of immunotherapy currently used to treat some patients with leukemia and lymphoma, and it is under study for patients with other types of cancer. In this study, researchers are determining the best dose and preliminary effectiveness of CAR T-cell therapy in patients with multiple myeloma that has come back or continued to grow despite treatment.
With CAR T-cell therapy, white blood cells called T cells are removed from the patient, altered in the laboratory to recognize a protein on the patient’s cancer cells, multiplied to larger numbers, and returned to the patient to find and destroy cancer cells. In this study, the protein being targeted on myeloma cells is called BCMA and the treatment is called JCARH125. It is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have multiple myeloma that has come back or continued to grow after at least three prior regimens of therapy.
- Patients should recover from the serious side effects of previous treatments before entering the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.