NCT07778446RecruitingPhase 1/2
A Study to Test CRT-402 in Refractory Autoimmune Disease
A Phase 1/2 Dose Escalation and Expansion Study of CRT-402, an In Vivo CD19 Targeted CAR-T Therapy, in Refractory Autoimmune Disease
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 6 Aug 2026
- Start date
- 26 Aug 2026
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Myeloid Therapeutics
- NCT number
- NCT07778446
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 34
- From 26 Aug 2026 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior Cluster of differentiation 19 (CD19)-directed, cell, or gene therapy,
Other illness
- 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,
Lab values
- 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,
Other
- Clinical suitability for a less burdensome and/or approved therapeutic approach, as judged by the Investigator,
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.