RecruitingB-cell Mediated Autoimmune Disorders
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
Sponsor: TG Therapeutics, Inc.
You may qualify if…
- ✓ PMS and RMS inclusion criteria:
- ✓ 1. Age 18 years to ≤60 years (inclusive) at screening.
- ✓ 2. Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening.
- ✓ 3. Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (non-active or active), or Relapsing MS (RMS).
- ✓ 4. Documented evidence of disability progression independent of relapse (PIRA) at any point over the 12 months prior to the screening visit.
- ✓ 5. Willingness and ability to undergo lumbar puncture (LP) for cerebrospinal fluid (CSF) collection at protocol-specified timepoints, with no contraindications to the procedure in the opinion of the Investigator.
- ✓ NMOSD inclusion criteria:
- ✓ 1. Between age 18 and ≤ 75 years, inclusive at the time of signing the informed consent.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06680037 · last updated 2026-10-27