NCT07577583

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
153mo left

Started May 2027

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2027

Expected
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2039

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2039

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

12.6 years

First QC Date

April 27, 2026

Last Update Submit

May 5, 2026

Conditions

B-cell Mediated Autoimmune Disorders

Outcome Measures

Primary Outcomes (4)

  • 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 (4)

  • 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

  • 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

Study Arms (1)

Long-term Follow-up

Participants 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.

Other: No Intervention

Interventions

No InterventionOTHER

No Intervention

Long-term Follow-up

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Any participants receiving azer-cel in TG-Azercel -101 study will be enrolled in this LTFU study.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

TG Therapeutics Clinical Support Team

CONTACT

1-877-575-8489clinicalsupport@tgtxinc.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 11, 2026

Study Start (Estimated)

May 1, 2027

Primary Completion (Estimated)

December 1, 2039

Study Completion (Estimated)

December 1, 2039

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share