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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Luminary Therapeutics
Study ID
NCT07729995
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LMY-922 — BIOLOGICAL
    Allogeneic CAR-T cell therapy expressing the BAFF-ligand

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
94 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Standard Dose Escalation Assessment
    Open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose (MTD) of LMY-922 will be determined using dose-escalation 3+3 design. Dose Level -1: 75×10\^6 CAR-T cells Dose Level 1: 150×10\^6 CAR-T cells Dose Level 2: 300×10\^6 CAR-T cells Dose Level 3: 450×10\^6 CAR-T cells
  • Experimental: Part B: Conditioning Assessment
    Evaluation of LMY-922 without lymphodepletion in Part B will be initiated only after safety, tolerability, and dose parameters are established in Part A.
  • Experimental: Part C: Scheduling Assessment
    Evaluation of LMY-922 fractionated dosing with or without lymphodepletion in Part C will be initiated only after safety, tolerability, lymphodepletion regimen parameters and dose parameters are established in Part A and Part B. Participants will receive three equal fractionated doses of LMY-922 administered approximately 3 weeks apart (Days 0, 21, and 42). The total cumulative dose will be equivalent to the dose selected in Parts A and B.

Primary Outcome Measure

To evaluate the Incidence and Severity of Treatment-Emergent Adverse Events (Safety) of LMY-922 in Patients ≥16 Years of Age with Refractory Autoimmune Disease [ Time Frame: 24 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Susan Prockop, MD
[email protected]
617-355-3087

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By research site
Boston Children's Hospital· Boston, MA

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