CR-402 treatment for refractory autoimmune disease
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
Run by Myeloid Therapeutics · NCT07778446 · Data updated 2026-11-12
This study tests CRT-402, a CD19-targeted CAR-T therapy, in adults with active, treatment-resistant autoimmune diseases like SLE, systemic sclerosis, and inflammatory myopathy to see if it is safe and capable of helping control disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Myeloid Therapeutics Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Nedlands, Western Australia) |
| Status | Recruiting |
| Started | August 26, 2026 |
| Main results expected | December 1, 2028 |
| Study ends | August 1, 2029 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07778446 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older with active, refractory SLE, systemic sclerosis, or idiopathic inflammatory myopathy who have not adequately responded to standard therapies.
✕Probably not a fit
Participants whose disease does not respond to CRT-402 or who experience intolerable adverse effects may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, open-label, first-in-human Phase 1/2 trial that uses dose escalation and expansion to determine the safety, tolerability, and optimal dosing of CRT-402 in participants with refractory autoimmune diseases. The study will monitor safety outcomes, pharmacodynamics, and pharmacokinetics, while also exploring preliminary signs of efficacy. Participants must have active disease and adequate organ function, and will receive CRT-402 with close follow-up visits. The trial aims to establish a recommended Phase 2 dose for future research. The sponsor is Myeloid Therapeutics, with CREATE Medicines as a collaborator, at a site in Western Australia.
Why it matters
Potential benefit: If successful, participants may experience better control of their autoimmune disease and improved symptoms or reduced disease activity.
How similar studies have gone: Earlier CAR-T approaches for autoimmune conditions are limited; this first-in-human study explores a novel approach with potential for meaningful impact if safe and effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Clinical suitability for a less burdensome and/or approved therapeutic approach, as judged by the Investigator, * 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, * 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, * Pregnancy or lactation.
Where it's running
-
Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue
Nedlands, Western Australia, Australia Recruiting
Study contacts
- Study coordinator: Clinical Department
- Email: CRT402-clinical@createmedicines.com
- Phone: +1 617 465 1022
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.