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Azercabtagene zapreleucel

Phase 1

B-cell Mediated Autoimmune Disorders | Small molecule | Immunology |TG Therapeutics, Inc.|Last Updated: May 18, 2026

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06680037A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune DisordersPHASE1 RECRUITING 100 — — May 6, 2025Jan 1, 2030May 18, 20268 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Dose-Limiting Toxicities (DLTs)
From Day 0 to Day 28

DLT will be determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary Endpoints
Number of Participants with Treatment Emergent Adverse Events (TEAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Up to Day 720
Change From Baseline in CAR T-cell Toxicities
Baseline, up to Day 720
Pharmacokinetics (PK) Plasma Concentrations of Azer-cel
Up to Day 720
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Azer-celEXPERIMENTALParticipants will receive single dose of intravenous (IV) infusion of azer-cel at different dose levels, on Day 0 of the treatment period.
Interventions
NameTypeDescription
Azercabtagene zapreleucel (azer-cel)DRUGIV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: PMS and RMS inclusion criteria: 1. Age 18 years to ≤60 years (inclusive) at screening. 2. Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening. 3. Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (n...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06680037Enrollment: 32 → 100
LOWMay 24, 2026NCT06680037studyFirstPostDate: changed