B-cell Mediated Autoimmune DisordersNCT07577583
Long-term Follow-up (LTFU) of Participants Who Received Azer-Cel
An observational study of B-cell Mediated Autoimmune Disorders, run by TG Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- B-cell Mediated Autoimmune Disorders
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2027to 1 Dec 2039
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- No healthy volunteers
- Adult
Study population: Any participants receiving azer-cel in TG-Azercel -101 study will be enrolled in this LTFU study.
Who may be able to join
- 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.
Who cannot join
- 1. No unique exclusion criteria apply to this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Morrisville, North Carolina, 27560
About this study
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
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.
- Conditions
- B-cell Mediated Autoimmune Disorders
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant CEI
Measured: Up to 15 years
Number of Participants With Clinically Significant CEI Based on Severity
Measured: Up to 15 years
Duration of Clinically Significant CEI
Measured: Up to 15 years
Time to Onset of Clinically Significant CEI
Measured: Up to 15 years
Secondary outcomes (4)
Number of Participants With CEI and all Serious Adverse Events (SAEs)
Measured: 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.
Measured: Up to 15 years
Duration of Disease Response Measured by Number of MS Relapses
Measured: Up to 15 years
Duration of Disease Response Based on Number of T2 Lesions and Gd-enhancing T1 Lesions
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 May 2027 (estimated)
- Primary completion1 Dec 2039 (estimated)
- Study completion1 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Mediated Autoimmune DisordersStudies of the same condition, open and under way.
- More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577583
- Sponsor's protocol ID
- TG-Azercel-LTFU
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07577583
- Acronym / sponsor ID
- TG-Azercel-LTFU
- Conditions
- B-cell Mediated Autoimmune Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 1 Dec 2039 (estimated)
- Study completion
- 1 Dec 2039 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term Follow-up | – | Other: 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. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Any participants receiving azer-cel in TG-Azercel -101 study will be enrolled in this LTFU study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. No unique exclusion criteria apply to this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | Long-term Follow-up |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for B-cell Mediated Autoimmune Disorders
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 2
Exploratory Study of Anti-BCMA-CD19 CAR-T Cell Therapy in Relapsed or Refractory IgG4-Related Disease
IgG4 Related Disease, B-cell Mediated Autoimmune Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-cell Mediated Autoimmune Disorders, run by TG Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TG Therapeutics Clinical Support Team (1-877-575-8489, clinicalsupport@tgtxinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinically Significant CEI (time frame: Up to 15 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.