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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07778446
- Acronym / sponsor ID
- CRT-402-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Myeloid TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- CREATE Medicines
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT-402 | Experimental | Drug: CRT-402Participants will receive CRT-402 by intravenous infusion. Dose escalation will proceed according to protocol-defined safety criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT-402CRT-402 administered by intravenous infusion. | Drug | CRT-402 |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
Time frame: Up to 52 weeks
Adverse events (AEs) are any new or worsening medical problems that occur after starting the study treatment.
Incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Time frame: Up to 52 weeks
cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome ICANS will be graded using standard consensus criteria.
10 secondary outcomes
Assess emergence of anti-drug antibodies (ADAs)
Time frame: Up to 52 weeks
Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax)
Time frame: Day 1 through Day 22
Pharmacokinetic parameter: Area under the curve (AUC)
Time frame: Day 1 through Day 22
Pharmacokinetic parameter: Time to Maximum Concentration (tmax)
Time frame: Day 1 through Day 22
Pharmacokinetic parameter: Plasma clearance (CL)
Time frame: Day 1 through Day 22
Pharmacokinetic parameter: Volume of distribution (Vd)
Time frame: Day 1 through Day 22
Pharmacokinetic parameter: Mean Residence Time (MRT)
Time frame: Day 1 through Day 22
Pharmacokinetic parameter: Apparent terminal half-life (t1/2)
Time frame: Day 1 through Day 22
Pharmacokinetic parameter: Terminal elimination rate constant (λz).
Time frame: Day 1 through Day 22
Overall Response Rate (ORR), measured by disease-specific composite response criteria.
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Raff, MD, PhD study director
SVP Clinical Development, CREATE Medicines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Department (+1 617 465 1022, CRT402-clinical@createmedicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose-limiting toxicities (DLTs). (time frame: Up to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.