A Study to Test CRT-402 in Refractory Autoimmune Disease

Sponsor
Myeloid Therapeutics
Study ID
NCT07778446
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CRT-402 — DRUG
    CRT-402 administered by intravenous infusion.

Study Details

Patients with refractory autoimmune diseases often have limited treatment options and ongoing disease activity despite standard therapies. CRT-402 is an in vivo Cluster of differentiation 19 (CD19)-targeted CAR-T cell therapy designed to deplete CD19-positive B cells and promote immune system reset. This study evaluates the safety, tolerability, preliminary efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of CRT-402 in participants with active refractory systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM).

Key Dates

First listed
Aug 21, 2026
Start date
Aug 24, 2026
Status verified
Aug 2026
Primary completion
Dec 1, 2028
Completion
Aug 1, 2029

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CRT-402
    Participants will receive CRT-402 by intravenous infusion. Dose escalation will proceed according to protocol-defined safety criteria.

Primary Outcome Measure

Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose-limiting toxicities (DLTs). [ Time Frame: Up to 52 weeks ]

Central Contacts

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