About this trial
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
Eligibility criteria
Qualifiers
Age 18 years to ≤60 years (inclusive) at screening.
Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening.
Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (non-active or active), or Relapsing MS (RMS).
Documented evidence of disability progression independent of relapse (PIRA) at any point over the 12 months prior to the screening visit.
Disqualifiers
History of malignancy that has not been in remission for at least 2 years.
Viral Screening
Evidence of chronic active or history of hepatitis B virus (HBV).
Seropositive for human immunodeficiency virus (HIV) antibody.
Trial design
Treatments tested in this trial
- Azercabtagene zapreleucel (azer-cel)