OncoMatch/Clinical Trials/NCT07333430
Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma
Is NCT07333430 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Naive HBI0101 CAR-T for relapsed/refractory multiple myeloma (mm).
Treatment: Naive HBI0101 CAR-T — A Phase 1a/1b Open-Label Study with Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
R/R MM subjects must have been exposed to at least three prior lines of therapy including the following agents: proteasome inhibitor
Must have received: immunomodulatory agent
R/R MM subjects must have been exposed to at least three prior lines of therapy including the following agents: immunomodulatory (IMiDs) agent
Must have received: anti-CD38 antibody
R/R MM subjects must have been exposed to at least three prior lines of therapy including the following agents: anti-CD38 antibody
Lab requirements
Blood counts
ANC ≥ 1000 cells/mm3; platelet count ≥ 30,000 mm3; hemoglobin ≥ 8 g/dL; subjects with absolute lymphocyte count < 300 cells/mm3 may be excluded
Kidney function
estimated clearance ≥ 20 ml/min
Liver function
AST and/or ALT ≤ 2.5 x ULN; direct bilirubin ≤ 4x ULN
Cardiac function
left ventricular ejection fraction ≥ 40%
Inadequate hepatic function defined by AST and/or ALT > 2.5 x ULN and/or direct bilirubin > 4x ULN. Inadequate renal function defined by estimated clearance of <20(ml/min). Inadequate bone marrow function defined by ANC < 1000 cells/mm3, platelet count < 30,000 mm3, or hemoglobin < 8 g/dL. Subjects with absolute lymphocyte count < 300 cells/mm3 may be excluded. Left ventricular ejection fraction < 40%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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