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Protocol # 20-518

Status

Recruiting

Description

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

Condition

  • Multiple Myeloma
  • Multiple Myeloma in Relapse
  • Refractory Multiple Myeloma

Interventions

  • TriPRIL CAR T Cells
  • Cyclophosphamide
  • Fludarabine

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of adverse events (AEs)
  • Incidence of Dose Limiting Toxicity (DLT)

Secondary Outcome:

  • Overall Response Rate (ORR)
  • Overall Survival (OS)
  • Progression Free Survival (PFS)

Enrollment

18

Study Start Date

October 5, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Marcela V. Maus, M.D.,Ph.D.

Source

Massachusetts General Hospital

Official title

A Phase I Clinical Trial With TriPRIL CAR T Cells for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Clinicaltrials.gov Identifier

NCT05020444

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.