A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AZD0120, Cyclophosphamide, Fludarabine.
- Who it may be relevant to
- Registry conditions: Lupus Erythematosus, Systemic. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1b/2 Study of AZD0120, a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Refractory Systemic Lupus Erythematosus (SLE)
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.
Detailed description
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
Interventions
- Biological AZD0120
Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy.. - Drug Cyclophosphamide
Lymphodepletion - specified dose prior to receiving AZD0120 - Drug Fludarabine
Lymphodepletion - specified dose prior to receiving AZD0120
Primary outcome measures
- PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE) [Time frame: 2 years]
- PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 2 [Time frame: 2 years]
- PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE [Time frame: 2 years]
Secondary outcome measures (12)
- PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE [Time frame: 2 years]
- PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE [Time frame: 2 years]
Eligibility criteria
INCLUSION:
- 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
- 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.
- Have used at least two standard immunosuppressants (including one biological agent).
- SLEDAI-2K score ≥6 at screening.
- Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
- 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:
- Have received prior treatment with CAR T therapy directed at any target.
- Have received any therapy that is targeted to CD19 and/or BCMA
- Received allogenic stem cell transplant or autologous stem cell transplant.
- An active malignancy that is progressing or requires active treatment.
- Primary immunodeficiency
- Active viral or bacterial infection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Research Site — San Francisco
- Research Site — Stanford
- Research Site — Tampa
- Research Site — Atlanta
- Research Site — Chicago
- Research Site — Bethesda
- Research Site — Boston
- Research Site — St Louis
- … and 7 more centers
Australia · 2 centers
- Research Site — Darlinghurst
- Research Site — Melbourne
Canada · 1 center
- Research Site — Toronto
Identifiers
NCT: NCT06897930 · D8313C00001