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Assessing the safety and effectiveness of Azer-cel for 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

PHASE1 · TG Therapeutics, Inc. · NCT06680037

This study is testing a new treatment called Azer-cel to see if it is safe and effective for people with certain autoimmune disorders, especially those with progressive multiple sclerosis.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment32 (estimated)
Ages18 Years and up
SexAll
SponsorTG Therapeutics, Inc. (industry)
Drugs / interventionsCAR T
Locations9 sites (La Jolla, California and 8 other locations)
Trial IDNCT06680037 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and clinical activity of Azercabtagene zapreleucel (azer-cel) in participants suffering from B-cell mediated autoimmune disorders, specifically focusing on progressive forms of multiple sclerosis. The primary goal is to determine the recommended phase 2 dose (RP2D) of the treatment. Participants will be required to have discontinued any disease-modifying therapy prior to enrollment and will undergo specific eligibility assessments to ensure safety. The study is interventional and is currently in Phase 1.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with Primary Progressive MS or Secondary Progressive MS who have stopped their disease-modifying therapies.

Not a fit: Patients with a history of malignancy not in remission, or those who have undergone certain prior treatments like adoptive T-cell therapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with progressive forms of multiple sclerosis.

How similar studies have performed: While this approach is novel in the context of B-cell mediated autoimmune disorders, similar studies in other conditions have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants with Progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS.
2. Participants must have discontinued disease modifying therapy (DMT) prior to signing the ICF and meet the following washout criteria prior to receiving lymphodepletion.

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.

Where this trial is running

La Jolla, California and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: B-cell Mediated Autoimmune Disorders, Progressive forms of multiple sclerosis, Primary Progressive MS, Secondary Progressive MS, Multiple Sclerosis, Neuromyelitis optica spectrum disorder, Myasthenia Gravis, Chronic Inflammatory Demyelinating Polyneuropathy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.