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NCT06680037 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
A Phase 1 study of B-cell Mediated Autoimmune Disorders, sponsored by TG Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 8
- Study locations
NCT06680037: Recruiting Phase 1 study of B-cell Mediated Autoimmune Disorders, sponsored by TG Therapeutics.
NCT06680037 is a Phase 1 study of B-cell Mediated Autoimmune Disorders that is actively recruiting participants, run by TG Therapeutics. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06680037, a Phase 1 study of B-cell Mediated Autoimmune Disorders, is actively recruiting participants, sponsored by TG Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 8
- Study locations
Study Summary
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
Primary Outcome
DLT will be determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Conditions Studied
Interventions
- DRUG Azercabtagene zapreleucel (azer-cel)
Study Locations (8)
New York
- TG Therapeutics Investigational Trial Site - New York
- TG Therapeutics Investigational Trial Site - Rochester
Ohio
- TG Therapeutics Investigational Trial Site - Cleveland
- TG Therapeutics Investigational Trial Site - Columbus
California
- TG Therapeutics Investigational Trial Site - La Jolla
Kentucky
- TG Therapeutics Investigational Trial Site - Lexington
Michigan
- TG Therapeutics Investigational Trial Site - Ann Arbor
Nebraska
- TG Therapeutics Investigational Trial Site - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2025-05-06 |
| Est. Completion | 2029-01-01 |
| Phase | Phase 1 |
What NCT06680037 shows while recruiting
NCT06680037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 1 condition, with B-cell Mediated Autoimmune Disorders appearing as the primary indexed condition, and to 1 intervention - of which Azercabtagene zapreleucel (azer-cel) is the first listed.
NCT06680037 lists 8 locations in 6 states (New York, Ohio, California).
Frequently Asked Questions
What is clinical trial NCT06680037 about?
NCT06680037 is a clinical study titled "A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders". The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
What is the current status of trial NCT06680037?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2025-05-06. Estimated completion is 2029-01-01.
What conditions does trial NCT06680037 study?
This clinical trial studies the following conditions: B-cell Mediated Autoimmune Disorders.
What interventions are being tested in trial NCT06680037?
The interventions under investigation include: Azercabtagene zapreleucel (azer-cel) (DRUG).
Who is sponsoring clinical trial NCT06680037?
This trial is sponsored by TG Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06680037 being conducted?
This trial has 8 study locations across California, Kentucky, Michigan, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06680037's enrollment target sits among peer trials
32 1297th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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