CRT-402: CRT-402 administered by intravenous infusion.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose-limiting toxicities (DLTs). — 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). — Up to 52 weeks cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome ICANS will be graded using standard consensus criteria.
Trial sites (1)
Facility
City
Region
Status
Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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