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A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
NCT06680037 · View on ClinicalTrials.gov ↗
Study Summary
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06680037
The ClinicalTrials.gov registry entry for NCT06680037 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TG Therapeutics, which has 45 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06680037 reports 8 study locations spanning 6 distinct geographic areas — top geographies include New York, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06680037?
The interventions under investigation include: Azercabtagene zapreleucel (azer-cel) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06680037?
This trial is sponsored by TG Therapeutics, which has 45 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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