Recruiting
Phase 1

Azer-cel

Sponsor:

TG Therapeutics, Inc.

Code:

NCT06680037

Conditions

B-cell Mediated Autoimmune Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Azercabtagene zapreleucel (azer-cel)

Study Details

Brief summary:

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

Conditions

B-cell Mediated Autoimmune Disorders

Study ID

NCT06680037

Start date

May 6, 2025

Status verified date

Jul, 2026

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

NMOSD inclusion criteria:

1. Between age 18 and 65 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 ≤70 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 ≤70 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).
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. Viral Screening

1. Evidence of chronic active or history of hepatitis B virus (HBV).
2. Seropositive for human immunodeficiency virus (HIV) antibody.
3. History of bone marrow/hematopoietic stem cell or solid organ transplantation.
4. Prior treatment with adoptive T-cell therapy or any gene therapy product directed at any target (e.g. CAR T-cell therapy).

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Azer-cel

Participants will receive single dose of intravenous (IV) infusion of azer-cel at different dose levels, on Day 0 of the treatment period.

Interventions

Azercabtagene zapreleucel (azer-cel)

IV infusion

Primary outcome measure

  • Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: From Day 0 to Day 28 ]

Central Contacts and Locations

Central contacts

TG Therapeutics Clinical Support Team

1-877-575-8489clinicalsupport@tgtxinc.com

Locations

TG Therapeutics Investigational Trial Site

Recruiting

La Jolla, California, United States, 92093

TG Therapeutics Investigational Trial Site

Recruiting

Ann Arbor, Michigan, United States, 48019

TG Therapeutics Investigational Trial Site

Recruiting

Omaha, Nebraska, United States, 68198

TG Therapeutics Investigational Trial Site

Recruiting

New York, New York, United States, 10025

TG Therapeutics Investigational Trial Site

Recruiting

Rochester, New York, United States, 14642

TG Therapeutics Investigational Trial Site

Recruiting

Cleveland, Ohio, United States, 44195

TG Therapeutics Investigational Trial Site

Recruiting

Columbus, Ohio, United States, 43210

TG Therapeutics Investigational Trial Site

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

TG Therapeutics, Inc.

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Progressive forms of multiple sclerosis (PMS)
  • Primary Progressive MS (PPMS)
  • Secondary Progressive MS (SPMS)
  • Multiple Sclerosis (MS)
  • Neuromyelitis optica spectrum disorder (MNOSD)
  • Myasthenia Gravis (MG)
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by TG Therapeutics, Inc. on 2026-07-20.