Trials / Recruiting
RecruitingNCT06680037
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants With B-cell Mediated Autoimmune Disorders
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azercabtagene zapreleucel (azer-cel) | IV infusion |
Timeline
- Start date
- 2025-05-06
- Primary completion
- 2026-12-01
- Completion
- 2029-01-01
- First posted
- 2024-11-08
- Last updated
- 2026-04-07
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06680037. Inclusion in this directory is not an endorsement.