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A Study to Test CRT-402 in Refractory Autoimmune Disease

ConditionsAutoimmune DiseasesSystemic Lupus ErythematosusSystemic SclerodermaMyositis
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMyeloid Therapeutics

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Single group

Treatments tested in this trial

  • CRT-402

    Drug

    CRT-402 administered by intravenous infusion.

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: CRT-402Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 52 weeks
2

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.

Time frame
Up to 52 weeks

Secondary outcomes

1

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.

Time frame
Up to 52 weeks
2

Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax)

Time frame
Day 1 through Day 22
3

Pharmacokinetic parameter: Area under the curve (AUC)

Time frame
Day 1 through Day 22
4

Pharmacokinetic parameter: Time to Maximum Concentration (tmax)

Time frame
Day 1 through Day 22

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Myeloid Therapeutics

Lead sponsor

CREATE Medicines

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: