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Not yet recruiting NCT07577583

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

— Observational B-cell Mediated Autoimmune Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention.
Who it may be relevant to
Registry conditions: B-cell Mediated Autoimmune Disorders. Basic parameters: 18 years — 62 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Other No Intervention
    No Intervention

Primary outcome measures

  • Number of Participants With Clinically Significant CEI [Time frame: Up to 15 years]
  • Number of Participants With Clinically Significant CEI Based on Severity [Time frame: Up to 15 years]
  • Duration of Clinically Significant CEI [Time frame: Up to 15 years]
  • Time to Onset of Clinically Significant CEI [Time frame: Up to 15 years]
Secondary outcome measures (4)
  • Number of Participants With CEI and all Serious Adverse Events (SAEs) [Time frame: Up to 15 years]
  • Duration of Disease Response Measured by Expanded Disability Status Scale (EDSS) Scores [Time frame: Up to 15 years]
  • Duration of Disease Response Measured by Number of MS Relapses [Time frame: Up to 15 years]
  • Duration of Disease Response Based on Number of T2 Lesions and Gd-enhancing T1 Lesions [Time frame: Up to 15 years]

Eligibility criteria

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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07577583 · TG-Azercel-LTFU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗