Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
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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