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BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease

NCT07729995 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-07-28

No results posted yet for this study

Summary

Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory autoimmune disease, even after relapse following other treatments. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory autoimmune disease using a BAFF CAR-T cell manufacturing process with or without lymphodepletion regimen.

Conditions

  • Rheumatoid Arthritis (RA)
  • Systemic Lupus Erthematosus (SLE)
  • Dermatomyositis (DM)
  • Systemic Sclerosis (SSc)

Interventions

BIOLOGICAL

LMY-922

Allogeneic CAR-T cell therapy expressing the BAFF-ligand

Sponsors & Collaborators

  • Luminary Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2030-03-31
Completion
2030-03-31
FDA Drug
Yes

Countries

  • United States

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 NCT07729995 on ClinicalTrials.gov