NCT07224373

An Open-label Study of AZD0120 in Adults With Multiple Sclerosis

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 evaulated per disease cohort.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	AZD0120 - Regimen 1	Regimen 1, infusion of AZD0120
BIOLOGICAL	AZD0120 - Regimen 2	Regimen 2, infusion of AZD0120

Timeline

• Start date: 2025-12-09
• Primary completion: 2028-12-07
• Completion: 2028-12-07
• First posted: 2025-11-04
• Last updated: 2026-02-02

Locations

13 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study