Health TrialsbyHealthPanel

A Study of AZD0120 in Autoimmune Diseases

ConditionsSystemic SclerosisIdiopathic Inflammatory MyopathiesRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
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 systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of giving signed informed consent.

Adequate physiological function and reserve at screening.

Able to comply with recommended medication washout period.

Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator.

Disqualifiers

BMI at screening < 18 or > 35kg/m2.

Any prior CAR T exposure.

Unable or unwilling to remain within proximity (~2 hours travel time) of the administering investigational site for the first 28 days post study drug administration.

Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD0120

    Biological/Vaccine

    CD19/BCMA Autologous CAR T-cell therapy product

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: AZD0120 Regimen 1Experimental treatment 1 intervention
Group B: AZD0120 Regimen 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)

Incidence and severity of DLTs and TEAEs to evaluate the safety of AZD0120 and to confirm the recommended Phase 2 dose (RP2D) in each indication SSc, IIM, or RA

Time frame
1 year

Secondary outcomes

1

Cellular Kinetics - Cmax

The maximum concentration of CAR T cells achieved in the body.

Time frame
1 year
2

Cellular Kinetics - Tmax

The time point at which the Cmax is reached

Time frame
1 year
3

Cellular Kinetics - AUC

The area under the concentration-time curve, which represents the total drug exposure over a specific period.

Time frame
1 year
4

Cellular Kinetics - t½λz

The terminal elimination half-life.

Time frame
1 year

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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