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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: B-cell Mediated Autoimmune Disorders
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: TG Therapeutics Clinical Support Team; Phone Number: 1-877-575-8489; Email: clinicalsupport@tgtxinc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of Clinically Significant CEI	Up to 15 years
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
Time to Onset of Clinically Significant CEI	Up to 15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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

Collaborators and Investigators

• Sponsor: TG Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): December 1, 2039
• Study Completion (Estimated): December 1, 2039

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TG-Azercel-LTFU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No