A Phase I Clinical Trial With TriPRIL CAR T Cells for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
Marcela V. Maus, M.D.,Ph.D.
Summary
This research study involves the study of TriPRIL CAR T Cells for treating people with relapsed or refractory multiple myeloma and to understand the side effects when treated with TriPRIL CAR T Cells. This research study involves the study drugs:. * TriPRIL CAR T Cells * Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process
Description
This is a two-part, non-randomized, open label, single-site Phase 1 study of TriPRIL CAR T Cells as a treatment for relapsed or refractory multiple myeloma. This study consists of 2 parts: * Part A (Dose Escalation) : The investigators are looking to find the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tol…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. * Age ≥18 years at the time of signing informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Life expectancy of greater than 12 weeks * Histologically or cytologically confirmed diagnosis of relapsed/refractory multiple myeloma. Documented measurable disease includes at least one or more of the following criteria: * Serum M-protein ≥1.0 g/dL * Urine M-protein ≥200 mg/24 hours * Involved serum free light chain ≥100 mg/L with abnormal κ/λ ratio *…
Interventions
- DrugTriPRIL CAR T Cells
Intravenous infusion
- DrugCyclophosphamide
Intravenous infusion
- DrugFludarabine
Intravenous infusion
Location
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts