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

Last updated: June 30, 2025
Sponsor: TG Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

Azercabtagene zapreleucel (azer-cel)

Clinical Study ID

NCT06680037
TG-Azercel-101
  • Ages 18-60
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants with Progressive forms of Multiple Sclerosis including PrimaryProgressive and Secondary Progressive MS.

  2. Participants must have discontinued disease modifying therapy (DMT) prior to signingthe ICF and meet the following washout criteria prior to receiving lymphodepletion.

Exclusion

Exclusion Criteria:

  1. History of malignancy that has not been in remission for at least 2 years.

  2. Viral Screening

  3. Evidence of chronic active or history of hepatitis B virus (HBV).

  4. Seropositive for human immunodeficiency virus (HIV) antibody.

  5. History of bone marrow/hematopoietic stem cell or solid organ transplantation.

  6. Prior treatment with adoptive T-cell therapy or any gene therapy product directed atany target (e.g. CAR T-cell therapy).

Note: Please note, other protocol specified Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Azercabtagene zapreleucel (azer-cel)
Phase: 1
Study Start date:
May 06, 2025
Estimated Completion Date:
January 01, 2029

Connect with a study center

  • TG Therapeutics Investigational Trial Site

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • TG Therapeutics Investigational Trial Site

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • TG Therapeutics Investigational Trial Site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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