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

NCT07085676 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Systemic Sclerosis (SSc)
  • Idiopathic Inflammatory Myopathy (IIM)
  • Rheumatoid Arthritis (RA)
  • Systemic Lupus Erythematosus (SLE)
  • Multiple Sclerosis (MS) Primary Progressive
  • Multiple Sclerosis (MS) Secondary Progressive
  • Neuromyelitis Optica Spectrum Disorder (NMOSD)
  • Myasthenia Gravis (MG)
  • Antiphospholipid Antibody Syndrome

Interventions

BIOLOGICAL

HBI0101 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.

Sponsors & Collaborators

  • Polina Stepensky

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-11-01
Completion
2030-11-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085676 on ClinicalTrials.gov