Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05020444

TriPRIL CAR T Cells in Multiple Myeloma

Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2026-05-12

18

Participants Needed

1

Research Sites

333 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

TriPRIL CAR T Cells in Multiple Myeloma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willing to sign informed consent
  • Age 18 years or older at consent
  • ECOG performance status of 0 to 2
  • Life expectancy more than 12 weeks
  • Confirmed diagnosis of relapsed or refractory multiple myeloma with measurable disease by specific lab criteria
  • At least 3 prior systemic therapy regimens including proteasome inhibitor, IMiDs, and anti-CD38 antibody, or triple-refractory disease
  • Adequate organ and marrow function including oxygen saturation 2%, LVEF 4%, ANC 1.0k/bcL, platelet count 5k/bcL, creatinine clearance 3 mL/min, AST/ALT less than 3 times upper limit normal, bilirubin less than 1.5 times upper limit normal, and normal clotting times
  • Prior therapy adverse events resolved to grade 1 or less (except alopecia and sensory neuropathy allowed)
  • Prior or concurrent malignancies allowed if not interfering with study assessments
  • Agree to use effective birth control during study and 6 months after
Not Eligible

You will not qualify if you...

  • Systemic treatment for multiple myeloma within 14 days before leukapheresis unless approved
  • High-dose steroids or immunosuppressive therapy within 14 days before leukapheresis
  • Autologous stem cell transplant within 3 months before leukapheresis
  • Prior allogeneic stem cell transplant
  • CAR-T therapy within 6 months before leukapheresis
  • Plasma cell leukemia or history of it
  • Only extramedullary disease without measurable disease
  • Bispecific T cell engagers within 6 months of apheresis
  • Bendamustine within 6 months of apheresis
  • Solitary plasmacytomas without other measurable disease
  • Allergic reactions to similar compounds as CAR-T cells
  • Contraindications to fludarabine or cyclophosphamide doses
  • Unresolved prior therapy adverse events above grade 1 (except alopecia and sensory neuropathy)
  • Active infections requiring treatment
  • Symptomatic congestive heart failure
  • Unstable angina, arrhythmia, or recent myocardial infarction within 6 months
  • Significant lung dysfunction
  • Autoimmune disease requiring immunosuppressive therapy
  • Recent pulmonary embolism or uncontrolled thromboembolic events
  • Recent severe bleeding within 60 days
  • Active hepatitis B, C, or HIV infection (with exceptions for treated and controlled cases)
  • Active central nervous system malignancy or significant CNS pathology
  • Active malignancy other than myeloma needing therapy in past 3 years
  • Pregnant or breastfeeding females or females not using effective birth control
  • Significant medical, lab, or psychiatric conditions preventing participation
  • Concurrent medicines interfering with study as assessed by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

M

Matthew J Frigault, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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TriPRIL CAR T Cells in Multiple Myeloma | DecenTrialz