Autoimmune DiseasesPhase 1/2NCT07778446
A Study to Test CRT-402 in Refractory Autoimmune Disease
A Phase 1/2 study testing CRT-402 in people with Autoimmune Diseases and Systemic Lupus Erythematosus, run by Myeloid Therapeutics at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Scleroderma
- What is being tested?
- CRT-402
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Aug 2026to 1 Aug 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue
Nedlands, Western Australia, 6009
Prof. Merrilee Needham, +61 8 6382 5100, genmed1@linear.org.au
Merrilee Needham
About this study
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
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 the detailed description
This is a multicenter, open-label, Phase 1/2, first-in-human, dose escalation and expansion study designed to assess the safety and tolerability, as well as define the recommended Phase 2 dose (RP2D) of CRT-402 in participants with refractory autoimmune disease.
- Being tested
- CRT-402
- Medical subject headings
- Autoimmune Diseases, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-402Drug
CRT-402 administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| CRT-402 | Experimental | Participants will receive CRT-402 by intravenous infusion. Dose escalation will proceed according to protocol-defined safety criteria. Receives: Drug: CRT-402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
Adverse events (AEs) are any new or worsening medical problems that occur after starting the study treatment.
Measured: Up to 52 weeks
Incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome ICANS will be graded using standard consensus criteria.
Measured: Up to 52 weeks
Secondary outcomes (10)
Assess emergence of anti-drug antibodies (ADAs)
Serum for anti-drug antibody analysis will be collected at designated visits indicated in the Schedule of Assessments (SOA). Samples will be collected using standard site practices.
Measured: Up to 52 weeks
Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax)
Measured: Day 1 through Day 22
Pharmacokinetic parameter: Area under the curve (AUC)
Measured: Day 1 through Day 22
Pharmacokinetic parameter: Time to Maximum Concentration (tmax)
Measured: Day 1 through Day 22
Pharmacokinetic parameter: Plasma clearance (CL)
Measured: Day 1 through Day 22
Pharmacokinetic parameter: Volume of distribution (Vd)
Measured: Day 1 through Day 22
Pharmacokinetic parameter: Mean Residence Time (MRT)
Measured: Day 1 through Day 22
Pharmacokinetic parameter: Apparent terminal half-life (t1/2)
Measured: Day 1 through Day 22
Pharmacokinetic parameter: Terminal elimination rate constant (λz).
Measured: Day 1 through Day 22
Overall Response Rate (ORR), measured by disease-specific composite response criteria.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start26 Aug 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myeloid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CREATE Medicines
- Responsible party
- Sponsor
- Investigators
- Adam Raff, MD, PhD, Study director, SVP Clinical Development, CREATE Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778446
- Sponsor's protocol ID
- CRT-402-01
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No