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

A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants With B-cell Mediated Autoimmune Disorders

Reviewed by TrialFinderData Editorial Team · Updated Jun 26, 2026

A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders (NCT06680037) is a Phase 1 interventional studying B-cell Mediated Autoimmune Disorders, sponsored by TG Therapeutics, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For B-cell Mediated Autoimmune Disorders, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused B-cell Mediated Autoimmune Disorders subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: PMS and RMS Who May Qualify: 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 Who May Qualify: 1. Between age 18 and 65 years, inclusive at the time of signing the willing to sign a consent form. 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 Who May Qualify: 1. Age ≥18 and ≤70 years of age at the time of signing the willing to sign a consent form. 2. Diagnosed with gMG at least 1 year prior to the date of signing the willing to sign a consent form. 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Azercabtagene zapreleucel (azer-cel)

IV infusion

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.