The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
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.
History of malignancy that has not been in remission for at least 2 years.
Active venous thromboembolism (e.g., deep vein thrombosis or pulmonary embolism), clinically significant coagulopathy (e.g., disseminated intravascular coagulation), or current therapeutic anticoagulation (e.g., warfarin).
Viral and Tuberculosis (TB) Screening
Evidence of chronic active or history of hepatitis B virus (HBV).
Sequential
Azercabtagene zapreleucel (azer-cel)
DrugIV infusion
Number of Participants with Dose-Limiting Toxicities (DLTs)
DLT will be determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Number of Participants with Treatment Emergent Adverse Events (TEAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Change From Baseline in CAR T-cell Toxicities
Pharmacokinetics (PK) Plasma Concentrations of Azer-cel
Pharmacodynamics (PD) Plasma Concentrations of Azer-cel
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