A Study to Test CRT-402 in Refractory Autoimmune Disease

August 19, 2026 updated by: Myeloid Therapeutics

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue
        • Contact:
        • Principal Investigator:
          • Merrilee Needham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CRT-402
Participants will receive CRT-402 by intravenous infusion. Dose escalation will proceed according to protocol-defined safety criteria.
Drug: CRT-402
CRT-402 administered by intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 52 weeks
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.
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess emergence of anti-drug antibodies (ADAs)
Time Frame: Up to 52 weeks
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.
Up to 52 weeks
Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax)
Time Frame: Day 1 through Day 22
Day 1 through Day 22
Pharmacokinetic parameter: Area under the curve (AUC)
Time Frame: Day 1 through Day 22
Day 1 through Day 22
Pharmacokinetic parameter: Time to Maximum Concentration (tmax)
Time Frame: Day 1 through Day 22
Day 1 through Day 22
Pharmacokinetic parameter: Plasma clearance (CL)
Time Frame: Day 1 through Day 22
Day 1 through Day 22
Pharmacokinetic parameter: Volume of distribution (Vd)
Time Frame: Day 1 through Day 22
Day 1 through Day 22
Pharmacokinetic parameter: Mean Residence Time (MRT)
Time Frame: Day 1 through Day 22
Day 1 through Day 22
Pharmacokinetic parameter: Apparent terminal half-life (t1/2)
Time Frame: Day 1 through Day 22
Day 1 through Day 22
Pharmacokinetic parameter: Terminal elimination rate constant (λz).
Time Frame: Day 1 through Day 22
Day 1 through Day 22
Overall Response Rate (ORR), measured by disease-specific composite response criteria.
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myeloid Therapeutics

Collaborators

CREATE Medicines

Investigators

  • Study Director: Adam Raff, MD, PhD, SVP Clinical Development, CREATE Medicines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 24, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

August 6, 2026

First Submitted That Met QC Criteria

August 19, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRT-402-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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