A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants With B-cell Mediated Autoimmune Disorders
TG Therapeutics, Inc.
Summary
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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. NMOSD inclusion criteria: 1. Between age 18 and 65 years, inclusive at the time of signing the informed consent.…
Interventions
- DrugAzercabtagene zapreleucel (azer-cel)
IV infusion
Locations (8)
- TG Therapeutics Investigational Trial SiteLa Jolla, California
- TG Therapeutics Investigational Trial SiteAnn Arbor, Michigan
- TG Therapeutics Investigational Trial SiteOmaha, Nebraska
- TG Therapeutics Investigational Trial SiteNew York, New York
- TG Therapeutics Investigational Trial SiteRochester, New York
- TG Therapeutics Investigational Trial SiteCleveland, Ohio