RecruitingPhase 1NCT07333430

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

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


Sponsor

Hadassah Medical Organization

Enrollment

60 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR-T cell therapy called HBI0101 in people with multiple myeloma (a blood cancer) that has come back or stopped responding to previous treatments. CAR-T therapy re-engineers a patient's own immune cells to find and destroy cancer cells. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory multiple myeloma with measurable disease - You have received at least three prior lines of treatment, including a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-CD38 antibody - You have had a stem cell transplant or are not eligible for one **You may NOT be eligible if...** - Your myeloma has spread to the brain or spinal cord - You have an active serious infection - You have had prior CAR-T therapy targeting BCMA - Your organ function or blood counts do not meet the required levels 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

BIOLOGICALNaive HBI0101 CAR-T

Naïve 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 Naïve HBI0101 CART is provided cryopreserved.


Locations(1)

Hadassah MO, Jerusalem, 9574869

Jerusalem, Israel

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NCT07333430


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