A Study to Test CRT-402 in Refractory Autoimmune Disease

NCT07778446 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-08-21

No results posted yet for this study

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).

Conditions

Interventions

DRUG

CRT-402

CRT-402 administered by intravenous infusion.

Sponsors & Collaborators

CREATE Medicines
collaborator UNKNOWN
Myeloid Therapeutics
lead INDUSTRY

Principal Investigators

Adam Raff, MD, PhD · SVP Clinical Development, CREATE Medicines

Study Design

Allocation: NA
Purpose: TREATMENT
Masking: NONE
Model: SINGLE_GROUP

Eligibility

Min Age: 18 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2026-08-24
Primary Completion: 2028-12-01
Completion: 2029-08-01

Countries

Australia

Study Locations

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Entities

Diseases