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Recruiting NCT07295847

A Study of AZD0120 in Autoimmune Diseases

Phase I Interventional Systemic Sclerosis Idiopathic Inflammatory Myopathies Rheumatoid Arthritis

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.
Who it may be relevant to
Registry conditions: Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis. Basic parameters: 18 years — 75 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, Germany, Spain, Sweden +1
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, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases

Overview

This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).

Detailed description

This is a Phase 1b, open-label, multi-center, multi-cohort clinical study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, to evaluate the safety in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA) for determination of the recommended phase 2 dose for each disease cohort. Approximately 9-12 participants will be evaluated per disease cohort.

Interventions

  • Biological AZD0120
    CD19/BCMA Autologous CAR T-cell therapy product

Primary outcome measures

  • Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) [Time frame: 1 year]
Secondary outcome measures (12)
  • Cellular Kinetics - Cmax [Time frame: 1 year]
  • Cellular Kinetics - Tmax [Time frame: 1 year]
  • Cellular Kinetics - AUC [Time frame: 1 year]
  • Cellular Kinetics - t½λz [Time frame: 1 year]
  • Cellular Kinetics - Clast [Time frame: 1 year]
  • Cellular Kinetics - Tlast [Time frame: 1 year]
  • Cellular Kinetics - AUClast [Time frame: 1 year]
  • Anti-drug antibodies (ADA) developed against AZD0120 from baseline [Time frame: 1 year]
  • Proportion of participants with detectable replication competent lentivirus (RCL) at pre-specified post infusion timepoints. [Time frame: 1 year]
  • Change from baseline in the Disease Activity Score (DAS) 28-C-reactive protein (CRP). The DAS28-CRP is a measure from 0-10 with higher scores indicating greater disease activity. [Time frame: 1 year]
  • Change from baseline in modified Rodnan Skin Score (mRSS). The mRSS is a measure of skin thickness with a range of 0-51 with higher scores indicating more severe disease. [Time frame: 1 year]
  • Change from baseline in the total improvement score (TIS). The TIS ranges from 0-100 with higher scores indicating greater improvement. [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Capable of giving signed informed consent.
  • Adequate physiological function and reserve at screening.
  • Able to comply with recommended medication washout period.
  • Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator.
  • Willingness to remain on/start appropriate, highly effective methods of birth control or other acceptable criteria.

Exclusion criteria

  • BMI at screening < 18 or > 35kg/m2.
  • Any prior CAR T exposure.
  • Unable or unwilling to remain within proximity (\~2 hours travel time) of the administering investigational site for the first 28 days post study drug administration.
  • Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list.
  • Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening.
  • Has certain heart conditions that could make it unsafe or unsuitable to take part in the study.
  • Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation.
  • Uncontrolled hypertension (> 160/100 mmHg) or symptomatic hypertension.
  • Any central nervous system disease that may impact participants safety in the investigator's opinion.
  • Other concurrent autoimmune or autoinflammatory disease. Certain autoimmune/autoinflammatory diseases may be included after discussion with the medical monitor.
  • Evidence of clinically significant bleeding or active bleeding conditions within 90 days before screening
  • History of malignancy or ongoing treatment for prior malignancy. Certain malignancies may be excepted.
  • Known genetic inborn error of immunity and/or primary immunodeficiency.
  • Active viral, bacterial, or fungal infection, or any ongoing infection that requires systemic antimicrobial therapy in the 4 weeks prior to screening.
  • Seropositive for HIV.
  • Active viral hepatitis are excluded.
  • Active syphilis, positive for Treponema pallidum antibody.
  • Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion.
  • Not up-to-date on vaccinations per local/national health authority or institutional guidelines for immune-compromised individuals.
  • Known life threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including dimethyl sulfoxide.
  • Contraindications or hypersensitivity to fludarabine and cyclophosphamide.
  • Major surgery, or has surgery planned during the study.
  • Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment (whichever is later).
  • Plans to father a child while enrolled in this study or within 1 year after receiving study treatment (whichever is later).
  • Any issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to provide informed consent or any condition in the opinion of the investigator, participation would not be in the best interest of the participant.

Other protocol-defined eligibility criteria may apply.

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
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • Research Site — Tucson
  • Research Site — Stanford
  • Research Site — Chicago
  • Research Site — Ann Arbor
  • Research Site — St Louis
  • Research Site — New York
  • Research Site — Chapel Hill
  • Research Site — Seattle
Germany · 6 centers
  • Research Site — Berlin
  • Research Site — Erlangen
  • Research Site — Hamburg
  • Research Site — Jena
  • Research Site — Mainz
  • Research Site — Würzburg
Spain · 3 centers
  • Research Site — Barcelona
  • Research Site — Madrid
  • Research Site — Madrid
Australia · 2 centers
  • Research Site — Darlinghurst
  • Research Site — Waratah
United Kingdom · 2 centers
  • Research Site — Edinburgh
  • Research Site — London
Sweden · 1 center
  • Research Site — Huddinge

Identifiers

NCT: NCT07295847 · D8318C00001 · 29707

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗