Health Trials

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

ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18-years-old to ≤ 60-years-old at the time of consent

Written informed consent in accordance with federal, local, and institutional guidelines

Adequate physiological function and reserve at screening

Participants should have an EDSS of ≤ 6.5 at screening.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD0120 - Regimen 1

    Biological/Vaccine

    Regimen 1, infusion of AZD0120

  • AZD0120 - Regimen 2

    Biological/Vaccine

    Regimen 2, infusion of AZD0120

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Arm/Group 1: AZD0120 RMSExperimental treatment 2 interventions
Group B: Arm/Group 2: AZD0120 PMSExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Incidence and severity of Dose Limiting Toxicity (DLT) over 104 weeks following AZD0120 administration.

Time frame
Day 1 to day 29, and over 104 weeks
2

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

Incidence and severity of Adverse Events (AE) over 104 weeks following AZD0120 administration.

Time frame
Day 1 to day 29, and over 104 weeks
3

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

Incidence and severity of Serious Adverse Events (SAE) over 104 weeks following AZD0120 administration.

Time frame
Day 1 to day 29, and over 104 weeks
4

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

Incidence and severity of Treatment Emergent Adverse Events (TEAE) over 104 weeks following AZD0120 administration.

Time frame
Day 1 to day 29, and over 104 weeks

Secondary outcomes

1

Evaluate the optimum regimen with AZD0120 in MS participants to determine the RP2D in each disease cohort

Change from baseline in peripheral B-cell counts following AZD0120 administration

Time frame
Over 104 weeks
2

Evaluate the optimum regimen with AZD0120 in MS participants to determine the RP2D in each disease cohort

CK parameters in peripheral B-cell counts following AZD0120 administration

Time frame
Over 104 weeks
3

Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

Annualized Relapse Rate (ARR) over 104 weeks (RMS cohort only)

Time frame
Over 104 weeks
4

Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

Time to onset participants with CDP-12 over 104 weeks

Time frame
Over 104 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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