RecruitingPhase 2NCT06971380

Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis

A Phase 2 Trial to Study Efficacy and Safety of HBI0101 (NXC-201) CART in Subjects With Multiple Myeloma and Light-Chain Amyloidosis.


Sponsor

Polina Stepensky

Enrollment

180 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing HBI0101 (also called NXC-201), a CAR-T cell therapy — where a patient's own immune cells are engineered in a lab to recognize and attack cancer cells — for people with multiple myeloma (a blood cancer) or light-chain amyloidosis (a protein buildup disease) that has relapsed or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older with confirmed multiple myeloma or light-chain amyloidosis - Your cancer has relapsed or is refractory (no longer responding) to previous treatments - You have received at least two prior treatment regimens, including drugs called proteasome inhibitors and immunomodulatory drugs (if you have myeloma) - You have measurable disease at the time of screening - Your organ function is adequate **You may NOT be eligible if...** - You have active, uncontrolled infection - You have a history of certain serious autoimmune diseases - You have received prior CAR-T therapy targeting the same cancer protein (BCMA) - You have active central nervous system involvement of your cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHBI0101 CART

HBI0101 CART is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA. The HBI0101 CART may be provided fresh or cryopreserved.


Locations(1)

Hadassah MO

Jerusalem, Israel

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NCT06971380


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