RecruitingPhase 1NCT07085676

Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases

A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases

Sponsor

Polina Stepensky

Enrollment

60 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)Systemic Lupus Erythematosus (SLE)Systemic Sclerosis (SSc)Idiopathic Inflammatory Myopathy (IIM)

Summary

A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing HBI0101, a CAR-T cell therapy where a patient's own immune cells are re-engineered to suppress the overactive immune response in severe autoimmune diseases — specifically lupus (SLE), systemic sclerosis (SSc), inflammatory muscle disease (IIM), or rheumatoid arthritis (RA) that have not responded to standard treatments. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with lupus, systemic sclerosis, inflammatory myopathy, or rheumatoid arthritis - Your heart pumping function is adequate (ejection fraction above 45%) - You have no active serious infection - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have severe kidney, liver, or lung disease - You have active serious infections - You are in poor overall functional health - 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.