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December 8, 2025BloodOpen Access

BCMA-targeted CAR T-cell therapy in refractory autoimmune diseases: Initial Results from a Phase 1 clinical trial

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Authors

HCHadass Pri ChenEZEran ZimranMAMiri Assayag

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Overview

Phase 1 trial demonstrates safety and clinical improvement across autoimmune diseases, highlighting BCMA-targeted CAR T-cell potential.

Key Points

  • To evaluate the safety and preliminary efficacy of BCMA-targeted CAR T-cell therapy in refractory autoimmune diseases.
  • Phase 1, open-label trial conducted at a single center
  • Six patients with severe, treatment-refractory autoimmune diseases received HBI0101 CAR T-cell infusion
  • Lymphodepleting chemotherapy was administered prior to CAR T infusion
  • Monitoring of adverse events and clinical responses post-treatment
  • Clinical responses observed in multiple autoimmune phenotypes within a maximum follow-up of 6 months
  • Marked improvement in muscle strength for a patient with idiopathic inflammatory myopathies
  • Significant reduction in skin fibrosis measured by Modified Rodnan Skin Score in two patients with systemic sclerosis
  • Patient with systemic lupus erythematosus showed normalization of complement levels and decline in serum creatinine

Cite This Study

Chen et al. (2025) studied this question.

synapsesocial.com/papers/69362f634fa91c937236ddb4https://doi.org/10.1182/blood-2025-2378
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Bispecific CAR T cell therapy targeting BCMA and CD19 in relapsed/refractory multiple myeloma: a phase I/II trial2024 · 112 citations
  2. 2BCMA CAR T-cell therapy in newly diagnosed primary plasma cell leukemia ineligible for transplantation: An open label, single-arm, phase 2 study (CAREMM-002)2025 · 2 citations
  3. 3Safety and preliminary efficacy of a novel loop-optimized, BCMA/CD19 bispecific CAR-T therapy for refractory or relapsed autoimmune diseases patients2025
  4. 4TSCM-predominant allogeneic anti-BCMA CAR-T therapy for relapsed/refractory multiple myeloma: preclinical characterization and interim results from a phase 1 trial2025 · 7 citations
  5. 5Durable remissions with BCMA-specific chimeric antigen receptor (CAR)-modified T cells in patients with refractory/relapsed multiple myeloma.2017 · 67 citations