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

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis
• Interventions: Biological: AZD0120 - Regimen 1; Biological: AZD0120 - Regimen 2

• Registration Number: NCT07224373
• Lead Sponsor: AstraZeneca

Brief 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.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-21
• Study First Submitted QC: 2025-10-31
• Last Update Submitted: 2025-10-31
• Study First Posted: 2025-11-04
• Last Update Posted: 2025-11-04
• Study Start: 2025-12-23
• Primary Completion: 2028-12-22
• Study Completion: 2028-12-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm/Group 1: AZD0120 RMS	AZD0120 - Regimen 1	AZD0120 RMS
Arm/Group 1: AZD0120 RMS	AZD0120 - Regimen 2	AZD0120 RMS
Arm/Group 2: AZD0120 PMS	AZD0120 - Regimen 1	AZD0120 PMS
Arm/Group 2: AZD0120 PMS	AZD0120 - Regimen 2	AZD0120 PMS

Primary Outcome Measures

Name	Time	Method
Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)	Day 1 to day 29, and over 104 weeks	Incidence and severity of Treatment Emergent Adverse Events (TEAE) over 104 weeks following AZD0120 administration.

Secondary Outcome Measures

Name	Time	Method
Evaluate the optimum regimen with AZD0120 in MS participants to determine the RP2D in each disease cohort	Over 104 weeks	CK parameters in peripheral B-cell counts following AZD0120 administration
Evaluate the preliminary efficacy of AZD0120 in RMS and PMS	Over 104 weeks	Change in MRI parameters including: mean number of new or enlarging T2 hyperintense lesions
Investigate the effects of AZD0120 on the function and quality of life of participants with MS	Over 104 weeks	Change in Neuro-QoL-fatigue from baseline
Characterize the CK and PD of AZD0120 in participants with MS	Over 104 weeks	B-cell counts
To monitor the incidence of vector-derived RCL	Over 104 weeks	Proportion of participants with detectable RCL at pre-specified post infusion timepoints
To assess the immunogenicity of AZD0120 in participants.	over 104 weeks	Changes in anti-AZD0120 antibody titers over 104 weeks

Trial Locations

Locations (1)

Research Site; 🇺🇸 Milwaukee, Wisconsin, United States