Recruiting

Azer-Cel

Sponsor:

TG Therapeutics, Inc.

Code:

NCT07577583

Conditions

B-cell Mediated Autoimmune Disorders

Eligibility Criteria

Sex: All

Age: 18 - 62

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

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.

Conditions

B-cell Mediated Autoimmune Disorders

Study ID

NCT07577583

Start date

May 1, 2027

Status verified date

Oct, 2026

Completion date

Dec 1, 2039

Anticipated

Primary completion date

Dec 1, 2039

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 62

Healthy Volunteers: Not accepted

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 Design

Enrollment

32 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

No Intervention

No Intervention

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

TG Therapeutics Clinical Support Team

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

Locations

TG Therapeutics Investigational Trial Site

Recruiting

Morrisville, North Carolina, United States, 27560

More Information

Sponsor

TG Therapeutics, Inc.

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by TG Therapeutics, Inc. on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.