Actively Recruiting

Phase 1
Age: 18Years - 60Years
All Genders
NCT07224373

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

Led by AstraZeneca · Updated on 2026-04-22

24

Participants Needed

19

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 60 years at the time of consent
  • Written informed consent according to guidelines
  • Adequate physiological function and reserve at screening
  • Diagnosis of relapsing MS (RMS) or active secondary progressive MS (SPMS) with EDSS 64 6.5 for RMS cohort
  • Evidence of active disease or intolerance to high efficacy therapy for 65 6 months for RMS cohort
  • Diagnosis of primary progressive MS (PPMS) or non-relapsing SPMS with EDSS between 3.0 and 6.5 for PMS cohort
  • Inadequate response or intolerance to 65 1 high-efficacy disease-modifying therapy for 65 6 months for PMS cohort
Not Eligible

You will not qualify if you...

  • Prior exposure to CAR-T or CAR-NK cell therapy
  • Splenectomy within 12 months before consent
  • History of solid organ transplant or active transplant waiting list
  • Prior autologous hematopoietic stem cell transplantation or total lymphoid irradiation
  • Significant cardiac conditions posing undue risk
  • Other central nervous system diseases affecting neurotoxicity evaluation, including epilepsy, stroke, dementia, Parkinson's, psychosis, or seizure disorders
  • Significant psychiatric condition (active or history)
  • Other immune-mediated diseases requiring ongoing systemic immunosuppression
  • Clinically significant bleeding or active bleeding diathesis within 90 days before screening
  • History or current malignancy treatment
  • Inborn errors of immunity or primary immunodeficiency
  • Seropositive for HIV or HTLV
  • Active viral hepatitis (any type)
  • Major surgery within 4 weeks before apheresis, lymphodepletion, or planned surgery during or within 4 weeks after treatment
  • Pregnant, breastfeeding, or planning pregnancy during study or within 1 year after treatment
  • Unable or unsafe to undergo cerebrospinal fluid exams or lumbar puncture
  • Contraindications to lumbar puncture
  • Unable or unwilling to undergo MRI scans as per protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

Research Site

Tucson, Arizona, United States, 85719

Withdrawn

2

Research Site

Aurora, Colorado, United States, 80045

Not Yet Recruiting

3

Research Site

Washington D.C., District of Columbia, United States, 20007

Not Yet Recruiting

4

Research Site

St Louis, Missouri, United States, 63110

Actively Recruiting

5

Research Site

New York, New York, United States, 10016

Not Yet Recruiting

6

Research Site

New York, New York, United States, 10032

Actively Recruiting

7

Research Site

Cleveland, Ohio, United States, 44195

Not Yet Recruiting

8

Research Site

Seattle, Washington, United States, 98104

Not Yet Recruiting

9

Research Site

Milwaukee, Wisconsin, United States, 53226

Not Yet Recruiting

10

Research Site

Liverpool, Australia, 2170

Not Yet Recruiting

11

Research Site

Melbourne, Australia, 3000

Actively Recruiting

12

Research Site

Melbourne, Australia, 3004

Not Yet Recruiting

13

Research Site

Waratah, Australia, 2298

Not Yet Recruiting

14

Research Site

Montreal, Quebec, Canada, H3A 1A1

Not Yet Recruiting

15

Research Site

Leipzig, Germany, 04103

Not Yet Recruiting

16

Research Site

Magdeburg, Germany, 39120

Not Yet Recruiting

17

Research Site

Würzburg, Germany, DE-97072

Not Yet Recruiting

18

Research Site

Cambridge, United Kingdom, CB2 2QQ

Not Yet Recruiting

19

Research Site

London, United Kingdom, SE5 9RS

Not Yet Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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