A Study to Test CRT-402 in Refractory Autoimmune Disease

NCT07778446 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: CRT-402-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Autoimmune Diseases; Systemic Lupus Erythematosus; Systemic Scleroderma; Myositis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 52 weeks

Secondary Outcomes (10)

• Assess emergence of anti-drug antibodies (ADAs)

  Up to 52 weeks

• Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax)

  Day 1 through Day 22

• Pharmacokinetic parameter: Area under the curve (AUC)

  Day 1 through Day 22

• Pharmacokinetic parameter: Time to Maximum Concentration (tmax)

  Day 1 through Day 22

• Pharmacokinetic parameter: Plasma clearance (CL)

  Day 1 through Day 22

Study Arms (1)

CRT-402

EXPERIMENTAL

Participants will receive CRT-402 by intravenous infusion. Dose escalation will proceed according to protocol-defined safety criteria.

Drug: CRT-402

Interventions

CRT-402 DRUG

CRT-402 administered by intravenous infusion.

CRT-402

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CREATE Medicines: collaborator
• Myeloid Therapeutics: lead

Study Sites (1)

Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Autoimmune Diseases; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Myositis

Condition Hierarchy (Ancestors)

Immune System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Adam Raff, MD, PhD

  SVP Clinical Development, CREATE Medicines

  STUDY DIRECTOR

Central Study Contacts

Clinical Department

CONTACT

+1 617 465 1022; CRT402-clinical@createmedicines.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 21, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)