A Phase 1b, Open-label, Multi-center, Randomized Study Evaluating the Safety and Tolerability of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cells, in Adults With Refractory Relapsing or Progressive Multiple Sclerosis
This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis.
• Diagnosis of RMS according to the 2017 McDonald Criteria (Thompson et al 2018) or diagnosis of relapsing, active SPMS according to Lublin et al 2014.
• Participants should have an EDSS of ≤ 6.5 at screening.
• Evidence of active disease(clinical relapses and MRI activities within 2 years prior to screening), or intolerance, while on a high efficacy disease-modifying therapy for ≥ 6 months.
• Diagnosis of PPMS according to the 2017 McDonald Criteria (Thompson et al 2018) and/or diagnosis of not active progressive SPMS according to Lublin et al 2014.
• Participants must have an EDSS of ≥ 3.0 and ≤ 6.5 at screening.
• Inadequate response ≥ 1 heDMT with ≥ 6 months treatment or intolerance.