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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active lupus (SLE), systemic sclerosis or inflammatory muscle disease (myositis) that has not improved enough with standard treatment.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Active, refractory systemic lupus erythematosus, systemic sclerosis, or idiopathic inflammatory myopathy, with inadequate response or intolerance to standard therapy.
- Earlier treatment
- Standard therapy must not have worked well enough or must not have been tolerated. Prior CD19-directed, cell or gene therapy is not allowed.
Main reasons for not taking part
- Prior CD19-directed, cell or gene therapy
- History of bone marrow, stem cell or solid organ transplant
- Active or inadequately treated infection, including HIV, hepatitis B or C, or tuberculosis
- Pregnancy or breastfeeding
- The investigator judges that a less burdensome or approved treatment would suit the person
Read by machine on 9 November 2026.
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.