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Recruiting Phase 1

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

NCT06680037 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2025-05-06
Last updated
2026-10-27

Condition(s) studied

B-cell Mediated Autoimmune Disorders

Investigational drug(s) / intervention(s)

Azercabtagene zapreleucel (azer-cel) →

Azercabtagene zapreleucel (azer-cel): IV infusion

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 (non-active or active), or Relapsing MS (RMS). 4. Documented evidence of disability progression independent of relapse (PIRA) at any point over the 12 months prior to the screening visit. 5. Willingness and ability to undergo lumbar puncture (LP) for cerebrospinal fluid (CSF) collection at protocol-specified timepoints, with no contraindications to the procedure in the opinion of the Investigator. NMOSD inclusion criteria: 1. Between age 18 and ≤ 75 years, inclusive at the time of signing the informed consent. 2. 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). 3. Diagnosis of anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive at screening (verified by the allocated central laboratory) and Neuromyelitis Optica Spectrum Disorder (NMOSD). 4. Must meet the appropriate NMOSD treatment washout criteria prior to receiving lymphodepletion. MG Inclusion criteria: 1. Age ≥18 and ≤75 years of age at the time of signing the informed consent. 2. Diagnosed with gMG at least 1 year prior to the date of signing the informed consent. 3. Confirmation of MG Diagnosis: 1. Positive serologic test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific kinase (MuSK) antibodies confirmed at screening AND 2. 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. 4. MG activities of daily living (MG-ADL) score ≥6 at screening. CIDP Inclusion criteria 1. Age ≥18 and ≤75 years of age at the time of signing the informed consent. 2. Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Separately, Autoimmune Nodopathy (AN) participants with anti-CNTN1 or anti-NF155/anti-NF186, as confirmed by serological testing, may be included. 3. CIDP Disease Activity Status (CDAS): CDAS score ≥3 at screening. 4. INCAT Disability Score: INCAT disability score ≥4 to ≤9 score at screening. General Exclusion Criteria: 1. History of malignancy that has not been in remission for at least 2 years. 2. Active venous thromboembolism (e.g., deep vein thrombosis or pulmonary embolism), clinically significant coagulopathy (e.g., disseminated intravascular coagulation), or current therapeutic anticoagulation (e.g., warfarin). 3. Viral and Tuberculosis (TB) Screening 1. Evidence of chronic active or history of hepatitis B virus (HBV). 2. Seropositive for human immunodeficiency virus (HIV) antibody. 4. History of bone marrow/hematopoietic stem cell or solid organ transplantation. 5. Prior treatment with any gene therapy product directed at any target (e.g. CAR T-cell therapy), with the exception of azer-cel. Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

  • 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.

Trial sites (8)

FacilityCityRegionStatus
TG Therapeutics Investigational Trial Site La Jolla California Recruiting
TG Therapeutics Investigational Trial Site Ann Arbor Michigan Recruiting
TG Therapeutics Investigational Trial Site Omaha Nebraska Recruiting
TG Therapeutics Investigational Trial Site New York New York Recruiting
TG Therapeutics Investigational Trial Site Rochester New York Recruiting
TG Therapeutics Investigational Trial Site Cleveland Ohio Recruiting
TG Therapeutics Investigational Trial Site Columbus Ohio Recruiting
TG Therapeutics Investigational Trial Site Milwaukee Wisconsin Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06680037 on ClinicalTrials.gov ↗ ← All trials in the USA