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Azercabtagene zapreleucel

Phase 1

B-cell Mediated Autoimmune Disorders | Small molecule | Immunology |TG Therapeutics, Inc.|Last Updated: Jul 20, 2026

Target and mechanism

Target class-Cel (Cell Tx)
ModalitySmall molecule

Also known as Azercabtagene zapreleucel (azer-cel)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Azercabtagene zapreleucel · 1 trial · 1 indication

Phase 1 1
NCT06680037A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune DisordersB-cell Mediated Autoimmune Disorders
RECRUITING100 Analytics
PHASE1RECRUITING
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune DisordersUnlock trial analytics

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 to 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)

LOWJul 20, 2026NCT06680037lastUpdatePostDate: changed
LOWJul 20, 2026NCT06680037lastUpdatePostDate: changed
LOWJun 18, 2026NCT06680037lastUpdatePostDate: changed
LOWJun 18, 2026NCT06680037lastUpdatePostDate: changed
LOWJun 18, 2026NCT06680037lastUpdatePostDate: changed

Frequently asked questions about Azercabtagene zapreleucel

What is Azercabtagene zapreleucel used for?

Azercabtagene zapreleucel (azer-cel) is an investigational cell therapy being studied for the treatment of B-cell mediated autoimmune disorders. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does Azercabtagene zapreleucel target?

Azercabtagene zapreleucel is a cell therapy that targets B cells, which are implicated in autoimmune disorders. By targeting these cells, it aims to modulate the immune response in conditions where B cells drive disease pathology.

Who is developing Azercabtagene zapreleucel?

Azercabtagene zapreleucel is being developed by TG Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol TGTX. The company is conducting clinical trials to evaluate the safety and activity of this investigational therapy.

What phase is Azercabtagene zapreleucel in?

Azercabtagene zapreleucel is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency and is still being studied in clinical trials.

What clinical trials is Azercabtagene zapreleucel in?

Azercabtagene zapreleucel is being evaluated in a Phase 1 clinical trial with the identifier NCT06680037. This study is assessing the safety and clinical activity of azer-cel in participants with B-cell mediated autoimmune disorders and is currently recruiting in the United States.

Is Azercabtagene zapreleucel the same as azer-cel?

Yes, Azercabtagene zapreleucel is also known as azer-cel. The shorter name is used in clinical trial documentation and communications to refer to the same investigational cell therapy.