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CRT-402

Phase 1

Autoimmune Diseases | Small molecule | Immunology |cbdMD, Inc.|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

CRT-402 · 1 trial · 4 indications

Phase 1 1
NCT07778446A Study to Test CRT-402 in Refractory Autoimmune DiseaseAutoimmune Diseases
NOT YET_RECRUITING34 Analytics
PHASE1NOT YET_RECRUITING
A Study to Test CRT-402 in Refractory Autoimmune Disease
Autoimmune Diseases
NCT0777844634
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Study Endpoints

Primary Endpoints

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.

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
CRT-402DRUGCRT-402 administered by intravenous infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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, c...

Countries:Australia
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