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OncoMatch/Clinical Trials/NCT07333430

Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma

Is NCT07333430 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Naive HBI0101 CAR-T for relapsed/refractory multiple myeloma (mm).

Phase 1RecruitingHadassah Medical OrganizationNCT07333430Data as of Jun 2026Location: Israel

Treatment: Naive HBI0101 CAR-TA 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.

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Extracted eligibility criteria

Treatments studied

Other

Naive HBI0101 CAR-T

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

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.

Frequently asked questions

Is NCT07333430 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received proteasome inhibitor and immunomodulatory agent.

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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