A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders

Recruiting now · Phase 1

Conditions studied: B-cell Mediated Autoimmune Disorders

In brief

The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).

Key facts

Study ID

NCT06680037

Run by

TG Therapeutics, Inc.

People needed

100

Starts

2025-05-06

Expected to finish

2030-01-01

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• PMS and RMS inclusion criteria:
• Age 18 years to ≤60 years (inclusive) at screening.
• Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening.
• Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (non-active or active), or Relapsing MS (RMS).
• Documented evidence of disability progression independent of relapse (PIRA) at any point over the 12 months prior to the screening visit.
• NMOSD inclusion criteria:
• Between age 18 and 65 years, inclusive at the time of signing the informed consent.
• EDSS score between 2.0 and 7.0 at screening, inclusive (for higher EDSS, the Investigator must assess that the participant is reasonably able to participate in the study).
• Diagnosis of anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive at screening (verified by the allocated central laboratory) and Neuromyelitis Optica Spectrum Disorder (NMOSD).
• Must meet the appropriate NMOSD treatment washout criteria prior to receiving lymphodepletion.
• MG Inclusion criteria:
• Age ≥18 and ≤70 years of age at the time of signing the informed consent.
• Diagnosed with gMG at least 1 year prior to the date of signing the informed consent.
• Confirmation of MG Diagnosis:
• Positive serologic test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific kinase (MuSK) antibodies confirmed at screening AND
• One of the following (either historical or during screening):
• Abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation.
• Positive anticholinesterase test (e.g., edrophonium chloride test).
• Demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician.
• MG activities of daily living (MG-ADL) score ≥6 at screening.
• CIDP Inclusion criteria
• Age ≥18 and ≤70 years of age at the time of signing the informed consent.
• Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome).
• CIDP Disease Activity Status (CDAS): CDAS score ≥3 at screening.
• INCAT Disability Score: INCAT disability score ≥4 to ≤9 score at screening.

Where it is running

• TG Therapeutics Investigational Trial Site — La Jolla, California, United States (enrolling)
• TG Therapeutics Investigational Trial Site — Ann Arbor, Michigan, United States (enrolling)
• TG Therapeutics Investigational Trial Site — Omaha, Nebraska, United States (enrolling)
• TG Therapeutics Investigational Trial Site — New York, New York, United States (enrolling)
• TG Therapeutics Investigational Trial Site — Rochester, New York, United States (enrolling)
• TG Therapeutics Investigational Trial Site — Cleveland, Ohio, United States (enrolling)
• TG Therapeutics Investigational Trial Site — Columbus, Ohio, United States (enrolling)
• TG Therapeutics Investigational Trial Site — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.