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15-Year safety check for experimental cell therapy

NCT ID NCT07577583

Knowledge-focused Sponsor: TG Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks 32 people who received Azer-Cel, an experimental cell therapy for B-cell related autoimmune diseases, to monitor long-term safety for up to 15 years. Participants are checked for serious side effects and disease changes. The goal is to understand risks over time, not to test new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2027

An estimate. Start dates often move.

Expected to finish

Dec 2039

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 62 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autoimmune disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell mediated autoimmune disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.