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OncoMatch/Clinical Trials/NCT05020444

TriPRIL CAR T Cells in Multiple Myeloma

Is NCT05020444 recruiting? Yes, currently enrolling (Jun 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 Jun 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

Treatments studied

Chemotherapy

CyclophosphamideFludarabine

Other

TriPRIL CAR T Cells

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 →

Frequently asked questions

Is NCT05020444 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior systemic therapy, systemic steroid therapy, immunosuppressive therapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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