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NOT YET RECRUITING
NCT07778446
PHASE1/PHASE2

A Study to Test CRT-402 in Refractory Autoimmune Disease

Sponsor: Myeloid Therapeutics

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase 1/2 Dose Escalation and Expansion Study of CRT-402, an In Vivo CD19 Targeted CAR-T Therapy, in Refractory Autoimmune Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2026-08-24

Completion Date

2029-08-01

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DRUG

CRT-402

CRT-402 administered by intravenous infusion.

Locations (1)

Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue

Nedlands, Western Australia, Australia