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UCAR T-cell

Phase 1

Neuromyelitis Optica Spectrum Disorders | Small molecule | Immunology |Co-Diagnostics, Inc.|Last Updated: Dec 15, 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
NCT06939166Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune DiseasesEARLY_PHASE1 RECRUITING 12 — — Jun 17, 2025Oct 1, 2027Dec 15, 20251 China
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Study Endpoints
Primary Endpoints
The number and severity of dose-limiting toxicity (DLT) events
Within 28 Days After UCAR T-cell Infusion

DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.

The total number, incidence, and severity of AEs
Up to 90 days After UCAR T-cell Infusion
Secondary Endpoints
NMOSD、MS: Expanded Disability Status Scale (EDSS) score
Up to 24 Months After UCAR T-cell Infusion
NMOSD、MS: Modified Rankin Scale
Up to 24 Months After UCAR T-cell Infusion
MG: Quantitative Myasthenia Gravis Score (QMG)
Up to 24 Months After UCAR T-cell Infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
UCAR T-cell groupEXPERIMENTALUniversal allogeneic CD19/BCMA CAR T-cells
Interventions
NameTypeDescription
UCAR T-cellDRUGUniversal allogeneic anti-CD19/BCMA CAR T-cells
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age ≥ 18 years. * Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood. * Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosi...

Countries:China
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