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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06971380 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.
Check if I qualifyRelated pages