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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-21

Study Completion Date

2029-05-01

Brief Summary

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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.

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Detailed Description

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The study will enrol adult participants with refractory Systemic Lupus Erythematosus (SLE) The study will be run in 2 parts;

First part is Phase 1b during which the study aims to assess safety and tolerability of AZD0120 in patients in refractory SLE cohorts

Second part is Phase 2, during which the study aims to assess safety, tolerability and efficacy of the selected dose, following Phase 1b completion, in patients with refractory SLE

Conditions

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Lupus Erythematosus, Systemic

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Drug: AZD0120 Single infusion of AZD0120

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AZD0120

Single dose of AZD0120

Group Type EXPERIMENTAL

Fludarabine

Intervention Type DRUG

Lymphodepletion - specified dose prior to receiving AZD0120

AZD0120

Intervention Type BIOLOGICAL

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

Cyclophosphamide

Intervention Type DRUG

Lymphodepletion - specified dose prior to receiving AZD0120

Interventions

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Fludarabine

Lymphodepletion - specified dose prior to receiving AZD0120

Intervention Type DRUG

AZD0120

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

Intervention Type BIOLOGICAL

Cyclophosphamide

Lymphodepletion - specified dose prior to receiving AZD0120

Intervention Type DRUG

Other Intervention Names

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GC012F

Eligibility Criteria

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Inclusion Criteria

1. Males or females aged 18 through 70 years inclusive at the time of consent.
2. Written informed consent in accordance with federal, local, and institutional guidelines.
3. Must be able and willing to adhere to the study visit schedule and other protocol requirements
4. Adequate hepatic, renal, pulmonary, and cardiac function
5. Have a clinical diagnosis of SLE according to the EULAR/ American College of Rheumatology (ACR) 2019 criteria with a positive ANA ≥1:80 and a score ≥10.
6. Have used at least two standard immunosuppressants (including one biological agent).
7. SLEDAI-2K score ≥6 at screening.
8. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
9. For lupus nephritis: Diagnosis of proliferative lupus nephritis based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V LN according to the WHO 2003 ISN/RPS classification.

EXCLUSION:

1. Have received prior treatment with CAR T therapy directed at any target.
2. Have received any therapy that is targeted to CD19 and/or BCMA
3. Received allogenic stem cell transplant or autologous stem cell transplant.
4. An active malignancy that is progressing or requires active treatment.
5. Primary immunodeficiency
6. Active viral or bacterial infection

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No