C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Progressive Multiple Sclerosis Refractory to Standard Therapy

Korábbi kezelés

• Inadequate washout from prior MS therapy or specified recent immunomodulatory treatments.
• Prior CAR T-cell therapy, other genetically modified immune cell therapy, or gene therapy.

Más betegség

• RRMS, clinically isolated syndrome, radiologically isolated syndrome, or another diagnosis better explaining the neurologic course.
• Alternative inflammatory demyelinating disorders, including AQP4-antibody-positive NMOSD and MOG-antibody-associated disease.
• Active or chronic infection requiring antibiotics, or protocol-specified positive infectious disease testing.
• Specified major cardiovascular, neurologic, transplant, malignancy, bleeding/thromboembolic, allergy, or protocol-compliance exclusions.

Egyéb

• Pregnant or breastfeeding, or planning pregnancy during the protocol-defined follow-up period.

• Able to sign and date the informed consent form.
• Male or female, 18-55 years of age, body weight >=40 kg.
• Diagnosis of MS according to the 2024 McDonald criteria with cohort-specific progressive MS requirements.
• Cohort 1: active SPMS; Cohort 2: PPMS or non-active SPMS.
• Inadequate response to at least one prior high-efficacy disease-modifying therapy administered for at least 6 months.
• Documented disability progression over the prior 24 months.
• EDSS 3.0 to 6.5, inclusive.
• Meets protocol-defined disease-duration, CSF, organ-function, cardiac/pulmonary, pregnancy testing, contraception, vaccination, and cellular-therapy follow-up requirements.