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A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE

ConditionLupus Erythematosus, Systemic
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAstraZeneca

About this trial

This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females aged 18 through 70 years inclusive at the time of consent.

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

Must be able and willing to adhere to the study visit schedule and other protocol requirements

Adequate hepatic, renal, pulmonary, and cardiac function

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • AZD0120

    Biological/Vaccine

    Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..

  • Cyclophosphamide

    Drug

    Lymphodepletion - specified dose prior to receiving AZD0120

  • Fludarabine

    Drug

    Lymphodepletion - specified dose prior to receiving AZD0120

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: AZD0120Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE)

The incidence and severity of adverse events (AEs)

Time frame
2 years
2

PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 2

To determine the recommended phase 2 dose (RP2D) of AZD0120

Time frame
2 years
3

PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

Proportion of participants achieving SRI-4 response

Time frame
2 years

Secondary outcomes

1

PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

Proportion of participants achieving SLE Responder Index 4 (SRI-4) response over time

Time frame
2 years
2

PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

Proportion of participants achieving remission in SLE (DORIS) remission over time

Time frame
2 years
3

PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) over time

Time frame
2 years
4

PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response over time

Time frame
2 years

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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