Study Results
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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NOT_YET_RECRUITING
PHASE1
27 participants
INTERVENTIONAL
2025-12-16
2028-02-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
PARALLEL
TREATMENT
NONE
Study Groups
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AZD0120 Regimen 1
Participants will receive an infusion of AZD0120 Regimen 1.
AZD0120
CD19/BCMA Autologous CAR T-cell therapy product
AZD0120 Regimen 2
Participants will receive an infusion of AZD0120 Regimen 2.
AZD0120
CD19/BCMA Autologous CAR T-cell therapy product
Interventions
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AZD0120
CD19/BCMA Autologous CAR T-cell therapy product
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Stanford, California, United States
Research Site
Chicago, Illinois, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Seattle, Washington, United States
Research Site
Darlinghurst, , Australia
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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29707
Identifier Type: OTHER
Identifier Source: secondary_id
D8318C00001
Identifier Type: -
Identifier Source: org_study_id