RecruitingPhase 1

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

United States24 participantsStarted 2025-12-09

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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 2024 McDonald Criteria (Montalban et al 2025) or non-relapsing 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.

Exclusion criteria

✕. Any prior CAR-T or CAR-NK cell exposure.
✕. Underwent splenectomy within 12 months prior to signing the ICF.
✕. Received a solid organ transplant at any time or on an active transplant waiting list.
✕. Prior treatment with autologous hematopoietic stem cell transplantation or total lymphoid irradiation.
✕. Cardiac conditions or any other significant cardiac condition that would present undue risk to the participant in the investigator's opinion:
✕. Any other central nervous system disease including epilepsy, convulsive seizures, organic encephalopathy syndrome, non-MS related paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease or associated movement disorder, psychosis, CNS vasculitis, or any other neurological disease that may impact the ability to evaluate neurotoxicity. History of a seizure disorder even if the seizure disorder is well controlled with anti-epileptics.
✕. Participant has significant psychiatric condition (active or history of).
✕. History of other immune-mediated disease that required continued systemic immunosuppression/systemic disease-modifying agents.

What they're measuring

Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

Timeframe: Day 1 to day 29, and over 104 weeks

Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

Timeframe: Day 1 to day 29, and over 104 weeks

Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

Timeframe: Day 1 to day 29, and over 104 weeks

Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

Timeframe: Day 1 to day 29, and over 104 weeks

Trial details

NCT IDNCT07224373

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-07

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Multiple Sclerosis trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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 2024 McDonald Criteria (Montalban et al 2025) or non-relapsing 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.

Exclusion criteria

✕. Any prior CAR-T or CAR-NK cell exposure.
✕. Underwent splenectomy within 12 months prior to signing the ICF.
✕. Received a solid organ transplant at any time or on an active transplant waiting list.
✕. Prior treatment with autologous hematopoietic stem cell transplantation or total lymphoid irradiation.
✕. Cardiac conditions or any other significant cardiac condition that would present undue risk to the participant in the investigator's opinion:
✕. Any other central nervous system disease including epilepsy, convulsive seizures, organic encephalopathy syndrome, non-MS related paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease or associated movement disorder, psychosis, CNS vasculitis, or any other neurological disease that may impact the ability to evaluate neurotoxicity. History of a seizure disorder even if the seizure disorder is well controlled with anti-epileptics.
✕. Participant has significant psychiatric condition (active or history of).
✕. History of other immune-mediated disease that required continued systemic immunosuppression/systemic disease-modifying agents.

What they're measuring

Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

Timeframe: Day 1 to day 29, and over 104 weeks

Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

Timeframe: Day 1 to day 29, and over 104 weeks

Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

Timeframe: Day 1 to day 29, and over 104 weeks

Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

Timeframe: Day 1 to day 29, and over 104 weeks