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

NCT07577583 — Not yet recruiting, 32 participants, TG Therapeutics, Inc.
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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

RegistryNCT07577583
StatusNot yet recruiting
Study typeObservational
Enrollment32 (Estimated)
SponsorTG Therapeutics, Inc. (Industry)
ConditionsB-cell Mediated Autoimmune Disorders
InterventionsNo Intervention (Other)
Datesstart 2027-05-01 (estimated), primary completion 2039-12-01 (estimated), completion 2039-12-01 (estimated), first posted 2026-05-11, last updated 2026-05-11

Related Papers Related Patents Related Grants Related Experts
All trials for B-cell Mediated Autoimmune Disorders All trials of No Intervention

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Long-term Follow-upOther: No InterventionParticipants who received azer-cel in TG-Azercel -101 study will be followed-up for a total of 15 years until withdrawal of consent, lost to follow-up, or until death.
  • No Intervention (Other): No Intervention

+Outcome measures

Primary outcomes

  • Number of Participants With Clinically Significant CEI [Up to 15 years]
  • Number of Participants With Clinically Significant CEI Based on Severity [Up to 15 years]
  • Duration of Clinically Significant CEI [Up to 15 years]
  • Time to Onset of Clinically Significant CEI [Up to 15 years]

Secondary outcomes

  • Number of Participants With CEI and all Serious Adverse Events (SAEs) [Up to 15 years]
  • Duration of Disease Response Measured by Expanded Disability Status Scale (EDSS) Scores [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.
  • Duration of Disease Response Measured by Number of MS Relapses [Up to 15 years]
  • Duration of Disease Response Based on Number of T2 Lesions and Gd-enhancing T1 Lesions [Up to 15 years]

+Eligibility

Sex: All, ages: 18 Years to 62 Years

Inclusion Criteria:

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

Exclusion Citeria:

1\. No unique exclusion criteria apply to this study.