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SYS6020

Phase 1

Refractory Active Systemic Lupus Erythematosus | Small molecule | Immunology |Co-Diagnostics, Inc.|Last Updated: Nov 19, 2024

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 Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06694298A Study of SYS6020 Injection in Refractory Active Systemic Lupus ErythematosusPHASE1 NOT YET_RECRUITING 50Dec 26, 2024Jan 29, 2029Nov 19, 2024 -
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Study Endpoints
Primary Endpoints
The frequency and nature of DLT and the incidence of all adverse events and serious adverse events
28 days after infusion

Assess safety and tolerability of SYS6020 in patients with systemic lupus erythematosus

recommended dose (RD)
6 Months
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS).
6 Months

Proportion of participants who achieved systemic lupus erythematosus remission (DORIS) at 6 months.

Secondary Endpoints
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)
12 weeks
Proportion of participants with complete reduction of hormone dose
6 Months
Proportion of participants taking ≤5mg/ day of hormone
6 Months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SYS6020EXPERIMENTAL -
Interventions
NameTypeDescription
SYS6020DRUGBCMA Chimeric Antigen Receptor T Cell(SYS6020)Injection Intravenous infusion
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 1\. Age ≥18 years old, ≤70 years old; * 2\. SLE is diagnosed according to SLICC 2012 or EULAR/ACR 2019 revised criteria. * 3\. Patients are required to have received glucocorticoid combined with immunosuppressive agents and/or biological agents for more than 3 months, with a s...

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