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

Phase 2RecruitingNCT06897930

AstraZeneca150 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Lupus Erythematosus, Systemic

Interventions

AZD0120BIOLOGICAL

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

CyclophosphamideDRUG

Lymphodepletion - specified dose prior to receiving AZD0120

FludarabineDRUG

Lymphodepletion - specified dose prior to receiving AZD0120

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

INCLUSION: 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

Locations (16)

Research Site

San Francisco, California, United States

NOT_YET_RECRUITING

Research Site

Stanford, California, United States

Outcomes

Primary Outcomes

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

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

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

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

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

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

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

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

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