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: 1. Participants with Progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS. 2. Participants must have discontinued disease modifying therapy (DMT) prior to signing the ICF and meet the following washout criteria prior to receiving lymphodepletion. Exclusion Criteria: 1. History of malignancy that has not been in remission for at least 2 years. 2. Viral Screening 1. Evidence of chronic active or history of hepatitis B virus (HBV). 2. Seropositive for human immunodeficiency virus (HIV) antibody. 3. History of bone marrow/…
Interventions
- DrugAzercabtagene zapreleucel (azer-cel)
IV infusion
Locations (9)
- TG Therapeutics Investigational Trial SiteLa Jolla, California
- TG Therapeutics Investigational Trial SiteLexington, Kentucky
- 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