Long-term safety follow-up after Azer-Cel in B-cell autoimmune disorders
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
Run by TG Therapeutics, Inc. · NCT07577583 · Data updated 2026-11-12
This observational study follows people who already received Azer-Cel to see if any long-term safety events occur over up to 15 years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 62 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | TG Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Morrisville, North Carolina) |
| Status | Recruiting |
| Started | May 1, 2027 |
| Main results expected | December 1, 2039 |
| Study ends | December 1, 2039 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07577583 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who received at least one Azer-Cel dose in TG-Azercel-101 and can comply with long-term follow-up.
✕Probably not a fit
Patients who do not have long-term data needs or who are unable to participate in extended follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study collects long-term safety data from participants who received Azer-Cel in the TG-Azercel-101 trial. It is an observational design with no new treatment given, focusing on clinical events of interest over time. Eligibility requires prior Azer-Cel exposure and informed consent, with follow-up visits aligned to the protocol. Location is a TG Therapeutics site in Morrisville, NC, with sponsors and collaborators noted. The study aims to map long-term safety in B-cell mediated autoimmune disorders.
Why it matters
Potential benefit: Benefits may include a better understanding of long-term safety for Azer-Cel, informing future patient care and monitoring.
How similar studies have gone: Long-term follow-up studies in similar therapies have provided important safety signals and continue to inform practice, though results can vary by drug and indication.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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TG Therapeutics Investigational Trial Site
Morrisville, North Carolina, United States Recruiting
Study contacts
- Study coordinator: TG Therapeutics Clinical Support Team
- Email: clinicalsupport@tgtxinc.com
- Phone: 1-877-575-8489
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.