OncoMatch/Clinical Trials/NCT06971380
Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis
Is NCT06971380 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies HBI0101 CART for multiple myeloma, refractory to standard treatment.
Treatment: HBI0101 CART — A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients. The goal of the study is to evaluate the efficacy and safety of HBI0101 CART.
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
Subject suffering from multiple myeloma must have been exposed to at least two prior lines of therapy including proteasome inhibitor, immunomodulatory (IMiDs) therapy or anti-CD38 antibody
Must have received: immunomodulatory agent
Subject suffering from multiple myeloma must have been exposed to at least two prior lines of therapy including proteasome inhibitor, immunomodulatory (IMiDs) therapy or anti-CD38 antibody
Must have received: anti-CD38 antibody
Subject suffering from multiple myeloma must have been exposed to at least two prior lines of therapy including proteasome inhibitor, immunomodulatory (IMiDs) therapy or anti-CD38 antibody
Must have received: proteasome inhibitor
Subject with amyloidosis must have been exposed to at least one prior line of therapy which includes proteasome inhibitor or anti-CD38 antibody
Must have received: anti-CD38 antibody
Subject with amyloidosis must have been exposed to at least one prior line of therapy which includes proteasome inhibitor or anti-CD38 antibody
Lab requirements
Blood counts
ANC < 1000 cells/mm^3, platelet count < 30,000 mm^3, or hemoglobin < 8 g/dL excluded; absolute lymphocyte count < 300 cells/mm^3 may be excluded per investigator judgement
Kidney function
serum creatinine clearance/estimated clearance of <20(ml/min) excluded
Liver function
AST and/or ALT > 2.5 x ULN and direct bilirubin > 4x ULN excluded
Cardiac function
Echocardiogram with left ventricular ejection fraction < 40% excluded
Inadequate hepatic function defined by AST and/or ALT > 2.5 x ULN and direct bilirubin > 4x ULN. Inadequate renal function defined by serum creatinine clearance/estimated clearance of <20(ml/min). Inadequate bone marrow function defined by ANC < 1000 cells/mm^3, platelet count < 30,000 mm^3, or hemoglobin < 8 g/dL. Echocardiogram with left ventricular ejection fraction < 40%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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