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MC-1-50

Phase 1

Systemic Lupus Erythematosus (SLE) | Monoclonal antibody | Immunology |Precision BioSciences, Inc.|Last Updated: Dec 22, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06892145Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLEPHASE1 RECRUITING 12Jun 12, 2025Feb 16, 2028Dec 22, 20252 China
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Study Endpoints
Primary Endpoints
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
1 month

Dose-limiting toxicity after CD19 CAR-T cell infusion

Secondary Endpoints
Validity endpoint of MC-1-50 cells [Efficacy]
3 months
AUCS of MC-1-50 cells [Cell dynamics]
3 months
CMAX of MC-1-50 cell preparation [Cell dynamics]
3 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MC-1-50EXPERIMENTALPatients will be be treated with CD19 CAR- T cells
Interventions
NameTypeDescription
MC-1-50BIOLOGICALA single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study; 2. Age ≥ 18 years old , gender not limited; 3. Patient...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06892145studyFirstPostDate: changed