AZD0120 for Lupus

Recruiting at 2 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must be taking: Immunosuppressants, Biologicals

Must not be taking: CAR T, CD19/BCMA

Disqualifiers: Active malignancy, Primary immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

Trial Summary

What is the purpose of 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.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

Adults aged 18-70 with refractory Systemic Lupus Erythematosus (SLE) who've tried at least two standard immunosuppressants, including a biological agent, and have significant SLE-related organ involvement. Participants must have had prior CAR T therapy, be willing to follow the study schedule, and have good liver, kidney, lung, and heart function.

Inclusion Criteria

SLEDAI-2K score ≥6 at screening

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

Exclusion Criteria

Primary immunodeficiency

I have received treatment targeting CD19 or BCMA.

I have previously undergone CAR T therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b

Assessment of safety and tolerability of AZD0120 in patients with refractory SLE

2 years

Phase 2

Assessment of safety, tolerability, and efficacy of the selected dose of AZD0120 in patients with refractory SLE

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AZD0120

Trial Overview The trial is testing AZD0120 in combination with Cyclophosphamide and Fludarabine. It's an open-label study where all participants receive the same treatment to assess its safety and effectiveness against severe lupus symptoms that haven't responded to other treatments.

Participant Groups

Group I: AZD0120 Experimental Treatment 3 Interventions

Single dose of AZD0120

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology