A Study to Test CRT-402 in Refractory Autoimmune Disease
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
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
Treatments tested in this trial
- CRT-402
Treatment groups
34 Participants
are divided into 1 treatment groupSponsors and collaborators
Myeloid Therapeutics
Lead sponsor
CREATE Medicines
Collaborator
Source ClinicalTrials.gov