TriPRIL CAR T Cells in Multiple Myeloma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Marcela V. Maus, M.D.,Ph.D.
Study ID
NCT05020444
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TriPRIL CAR T Cells — DRUG
    Intravenous infusion
  • Cyclophosphamide — DRUG
    Intravenous infusion
  • Fludarabine — DRUG
    Intravenous infusion

Study Details

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

Key Dates

Start date
Oct 5, 2021
Status verified
May 2026
Primary completion
Feb 24, 2028
Completion
Feb 24, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TriPRIL CAR T Cells-Dose Escalation
    Prior to receiving TriPRIL CAR T Cells, participants will undergo two preparatory processes: * Leukapheresis: White blood cells will be collected and manufacture TriPRIL CAR T cells at a GMP manufacturing facility. * Lymphodepletion: On days, -5, -4. -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes TriPRIL CAR T Cells will be administered intravenously on day 0 using a 3+3 dose escalation design
  • Experimental: TriPRIL CAR T Cells-Dose Expansion
    Prior to receiving TriPRIL CAR T Cells, participants will undergo two preparatory processes: * Leukapheresis: White blood cells will be collected and manufacture TriPRIL CAR T cells at a GMP manufacturing facility. * Lymphodepletion: On days, -5, -4. -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes TriPRIL CAR T Cells will be administered intravenously on day 0 using the respective dose (at or below the Maximum Tolerated Dose-MTD), as determined during the dose escalation part.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Week 24 post dosing, and every three months until two years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Matthew J Frigault, MD
[email protected]
(617) 643-6175
Matthew J Frigault, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Massachusetts General Hospital Cancer Center· Boston, MA

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