CRT-402 for Lupus, Scleroderma and Myositis That Have Not Responded to Treatment
Tests CRT-402, a CAR-T therapy, in adults with hard-to-treat autoimmune diseases.
Plain-language title generated from the registry record
Registry title: A Study to Test CRT-402 in Refractory Autoimmune Disease
Key facts
- Where
- Nedlands, AustraliaSee the site
- Phase
- Phase 1/2
Where in Australia
- Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital AvenueNedlands, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Myeloid Therapeutics
- Trial code
- NCT07778446
- Record updated
- 22 October 2026
- Original description
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).Read full original descriptionShow less
A Phase 1/2 Dose Escalation and Expansion Study of CRT-402, an In Vivo CD19 Targeted CAR-T Therapy, in Refractory Autoimmune Disease
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).
Inclusion: Age 18 years or older; Diagnosis of active, refractory systemic lupus erythematosus, systemic sclerosis, or idiopathic inflammatory myopathy meeting established classification criteria, with inadequate response or intolerance to standard therapy; Adequate renal, hepatic, cardiac, and pulmonary function per protocol-defined criteria; Participants of reproductive potential must agree to use protocol-specified contraception during the study and for a defined period after dosing; Females of childbearing potential must have a negative pregnancy test before treatment; Must be willing and able to attend study visits and follow all study requirements.
Exclusion: Prior Cluster of differentiation 19 (CD19)-directed, cell, or gene therapy,; History of bone marrow/ hematopoietic stem cell or solid organ transplantation,; Active or inadequately treated infection, including Human immunodeficiency (HIV), hepatitis B or C, or tuberculosis,; Any medical condition or laboratory abnormality that, in the Investigator's judgment, would place the participant at unacceptable risk or confound interpretation of study data,; Clinical suitability for a less burdensome and/or approved therapeutic approach, as judged by the Investigator,; Pregnancy or lactation.