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

AstraZeneca

Summary

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.

Description

This study will evaluate AZD0120 for safety, including DLTs and TEAEs, by the SRC for determination of the Recommended Phase 2 dose for each disease cohort. Approximately 9-12 participants will be evaluated per disease cohort.

Eligibility

Age range: 18–60 years
Sex: All
Healthy volunteers

Detailed criteria

Participants are eligible to be included in the study only if all of the following criteria apply: Age 1. Age ≥ 18-years-old to ≤ 60-years-old at the time of consent Type of Participant and Disease Characteristics 2. Written informed consent in accordance with federal, local, and institutional guidelines 3. Adequate physiological function and reserve at screening RMS Cohort Specific Inclusion Criteria 4. Diagnosis of RMS according to the 2024 McDonald Criteria (Montalban et al 2025) or diagnosis of relapsing, active SPMS according to Lublin et al 2014. 5. Participants should have an…

Interventions

Biological
AZD0120 - Regimen 1
Regimen 1, infusion of AZD0120
Biological
AZD0120 - Regimen 2
Regimen 2, infusion of AZD0120

Locations (19)

Research Site
Tucson, Arizona
Research Site
Aurora, Colorado
Research Site
Washington D.C., District of Columbia
Research Site
St Louis, Missouri
Research Site
New York, New York
Research Site
New York, New York