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NCT Number: NCT07577583

Long-term Follow-up (LTFU) of Participants Who Received Azer-Cel

The main objective of this study is to collect data on the long-term safety of azer-cel, primarily through the capture of clinical events of interest (CEI) for up to 15 years following participation in TG-Azercel -101 study.

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Key information

Conditions

B-cell Mediated Autoimmune Disorders

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Received at least 1 dose of azer-cel in TG-Azercel -101 study.
  • Signed informed consent form (ICF).
  • Willingness and ability to adhere to the study schedule and all other protocol requirements.

Exclusion Citeria:

  • No unique exclusion criteria apply to this study.

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. Number of Participants With Clinically Significant CEI

    Time frame: Up to 15 years

  2. Number of Participants With Clinically Significant CEI Based on Severity

    Time frame: Up to 15 years

  3. Duration of Clinically Significant CEI

    Time frame: Up to 15 years

  4. Time to Onset of Clinically Significant CEI

    Time frame: Up to 15 years

Secondary outcomes

  1. Number of Participants With CEI and all Serious Adverse Events (SAEs)

    Time frame: Up to 15 years

  2. Duration of Disease Response Measured by Expanded Disability Status Scale (EDSS) Scores

    Time frame: Up to 15 years

    The EDSS is a standardized tool used to measure disability in participants with multiple sclerosis (MS). The EDSS scores range from 0 to 10, based on the severity of disability. Higher score indicates severity of disability.

  3. Duration of Disease Response Measured by Number of MS Relapses

    Time frame: Up to 15 years

  4. Duration of Disease Response Based on Number of T2 Lesions and Gd-enhancing T1 Lesions

    Time frame: Up to 15 years

Study contacts

Contact information is provided by the study sponsor or research team.

TG Therapeutics Clinical Support Team

CONTACT

[email protected]

1-877-575-8489

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

Long-term Follow-up (LTFU) of Study Participants Who Received Azer-Cel, An Allogeneic Chimeric Antigen Receptor T-Cell Product, in a TG Therapeutics, Inc., Clinical Study

Important dates

Study start
2027
Primary completion
2039
Study completion
2039
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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