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OncoMatch/Clinical Trials/NCT05020444

TriPRIL CAR T Cells in Multiple Myeloma

Is NCT05020444 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including TriPRIL CAR T Cells and Cyclophosphamide for multiple myeloma.

Phase 1RecruitingMarcela V. Maus, M.D.,Ph.D.NCT05020444Data as of May 2026

Treatment: TriPRIL CAR T Cells · Cyclophosphamide · FludarabineThis 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

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 3 prior lines

Must have received: proteasome inhibitor

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

Must have received: IMiD

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

Must have received: anti-CD38 antibody

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

Cannot have received: systemic therapy

Any prior systemic treatment for multiple myeloma within the 14 days prior to scheduled leukapheresis unless discussed with the medical monitor

Cannot have received: systemic steroid therapy

Exception: ≤10 mg prednisone or equivalent allowed

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

Cannot have received: immunosuppressive therapy

any other form of immunosuppressive therapy within 14 days prior to leukapheresis

Cannot have received: autologous stem cell transplantation

Autologous stem cell transplantation within 3 months prior to leukapheresis

Cannot have received: allogeneic stem cell transplantation

Any prior allogeneic stem cell transplantation

Cannot have received: CAR-T cell therapy

Other CAR-T cell therapy within 6 months of leukapheresis

Cannot have received: bispecific T cell engager

No Bispecific T cell engagers within 6 months of apheresis

Cannot have received: (bendamustine)

No bendamustine within 6 months of apheresis

Lab requirements

Blood counts

ANC ≥1.0k/μl, PLT ≥50k/μl (no platelet transfusion within 7 days; no neupogen within 7 days, neulasta within 14 days)

Kidney function

Creatinine clearance ≥30 mL/min and not on dialysis

Liver function

AST/ALT <3 x ULN; Direct bilirubin <1.5 x ULN (allow x 3 ULN for Gilbert's syndrome)

Cardiac function

LVEF ≥40% by ECHO or MUGA scan

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Massachusetts General Hospital Cancer Center · Boston, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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