TriPRIL CAR T Cells in Multiple Myeloma

Running, not enrolling · Phase 1

Conditions studied: Multiple Myeloma, Multiple Myeloma in Relapse, Refractory Multiple Myeloma

In brief

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 facts

Study ID

NCT05020444

Run by

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

People needed

16

Starts

2021-10-05

Expected to finish

2028-02-24

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Bone marrow plasma cells ≥30%
• Relapsed/refractory multiple myeloma with at least 3 prior regimens of systemic therapy including proteasome inhibitor, IMiDs and anti-CD38 antibody; or has "triple-refractory" disease following treatment with proteasome inhibitor, IMiD and anti-CD38 antibody, as part of the same or different regimens.
• Note: IMWG criteria defines refractory disease as disease progression on or within 60 days of receiving a therapy Note: Induction treatment with or without hematopoietic stem cell transplant and with or without maintenance is considered a single regimen.
• Adequate organ and marrow function as defined below:
• O2 saturation ≥92% on room air while awake
• LVEF ≥40% by ECHO or MUGA scan
• ANC ≥1.0k/μl, PLT ≥50k/μl, (NOTE: Platelet transfusion not allowed within 7 days; growth factor neupogen not allowed within 7 days, neulasta within 14 days)
• Creatinine clearance ≥30 mL/min and not on dialysis
• AST/ALT <3 x ULN
• Direct bilirubin <1.5 x ULN (allow x 3 ULN for Gilbert's syndrome)
• PTT, PT/INR <1.5 x ULN, unless on a stable dose of anti-coagulant for a thromboembolic event (Patients with any history of thromboembolic stroke; or history or Grade 2 or greater hemorrhage within 60 days are excluded)
• Resolution of AEs from any prior therapy to ≤ Grade 1 (≤ G2 alopecia and ≤ G2 sensory neuropathy are allowed, cytopenias allowed per eligibility criteria above)
• Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• The effects of TriPRIL CAR T cells on the developing human fetus are unknown. Male and female participants of childbearing potential must agree to use highly effective methods of birth control prior to study entry, for the duration of study participation, and through 6 months after completion of TriPRIL CAR T cells administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• NOTE: Highly effective contraception methods include:
• Total abstinence
• Female sterilization (tubal ligation, bilateral oophorectomy, and/or hysterectomy)

You may not qualify if…

• Treatment with any of the following therapies as specified below:
• Any prior systemic treatment for multiple myeloma within the 14 days prior to scheduled leukapheresis unless discussed with the medical monitor
• Receiving high-dose (e.g., >10 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to leukapheresis
• Autologous stem cell transplantation within 3 months prior to leukapheresis
• Any prior allogeneic stem cell transplantation
• Other CAR-T cell therapy within 6 months of leukapheresis
• Plasma cell leukemia or history of plasma cell leukemia
• Patients with extramedullary disease only without meeting criteria for measurable disease as per inclusion criteria above.
• No Bispecific T cell engagers withing 6 months of apheresis
• No bendamustine within 6 months of apheresis
• Patients with solitary plasmacytomas without evidence of other measurable disease
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to CAR- T cells
• Contraindication to the protocol-specified doses of fludarabine or cyclophosphamide
• Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of ≤ G2 alopecia and grade ≤2 sensory neuropathy.
• Active bacterial, viral, or fungal infection requiring systemic treatment (isolated fever may not constitute active infection in and of itself, e.g., related to disease)
• Symptomatic congestive heart failure
• Unstable angina, arrhythmia, or myocardial infarction (MI) within 6 months prior to screening
• Significant pulmonary dysfunction
• Auto-immune disease requiring immunosuppressive therapy
• Pulmonary embolism or DVT within three months of enrollment or uncontrolled thromboembolic events. Therapeutic dosing of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors) is allowed for history of DVT or PE if greater than three months from time of enrollment. Prophylactic anticoagulation is allowed.
• Recent severe hemorrhage (within the past 60 days)
• Seropositive for and with evidence of active hepatitis B or C infection at time of screening, or HIV seropositive
• Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable viral DNA for 6 months are eligible
• Subjects seropositive because of hepatitis B virus vaccine with no signs or active infection are eligible
• Subjects who had hepatitis C but have received antiviral therapy and show no detectable HCV viral RNA for 6 months are eligible

Where it is running

• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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