A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders

Inclusion criteria

• PMS and RMS inclusion criteria:
• 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.
• 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:
• Between age 18 and ≤ 75 years, inclusive at the time of signing the informed consent.
• EDSS score between 2.0 and 7.0 at screening, inclusive (for higher EDSS, the Investigator must assess that the participant is reasonably able to participate in the study).
• Diagnosis of anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive at screening (verified by the allocated central laboratory) and Neuromyelitis Optica Spectrum Disorder (NMOSD).
• Must meet the appropriate NMOSD treatment washout criteria prior to receiving lymphodepletion.
• MG Inclusion criteria:
• Age ≥18 and ≤75 years of age at the time of signing the informed consent.
• Diagnosed with gMG at least 1 year prior to the date of signing the informed consent.
• Confirmation of MG Diagnosis:
• Positive serologic test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific kinase (MuSK) antibodies confirmed at screening AND
• One of the following (either historical or during screening):
• Abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation.
• Positive anticholinesterase test (e.g., edrophonium chloride test).
• Demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician.
• MG activities of daily living (MG-ADL) score ≥6 at screening.
• CIDP Inclusion criteria
• Age ≥18 and ≤75 years of age at the time of signing the informed consent.
• Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Separately, Autoimmune Nodopathy (AN) participants with anti-CNTN1 or anti-NF155/anti-NF186, as confirmed by serological testing, may be included.
• CIDP Disease Activity Status (CDAS): CDAS score ≥3 at screening.
• INCAT Disability Score: INCAT disability score ≥4 to ≤9 score at screening.
• General

Exclusion criteria

• 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).
• Seropositive for human immunodeficiency virus (HIV) antibody.
• History of bone marrow/hematopoietic stem cell or solid organ transplantation.
• Prior treatment with any gene therapy product directed at any target (e.g. CAR T-cell therapy), with the exception of azer-cel.
• Note: Other protocol-specified Inclusion/Exclusion criteria may apply.