Purpose

This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ≥18 years of age at the time of consent. - ECOG performance status of 0 or 1. - Documented diagnosis of MM per IMWG diagnostic criteria. - Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody. - Have documented evidence of progressive disease per IMWG criteria. - Participant must have measurable disease at screening. - Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.

Exclusion Criteria

: - Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy. - Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. Some exceptions may apply. - Participant has significant cardiac, neurological, or psychiatric conditions. - Any other significant medical conditions such as: - Serious active or uncontrolled infection - Active autoimmune disease or a history of autoimmune disease within 2 years - Active plasma cell leukemia at the time of screening - Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF). - Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM. Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
AZD0120 will be administered by infusion
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AZD0120
AZD0120 will be administered by infusion
  • Biological: AZD0120
    AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.

Recruiting Locations

Research Site
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

Phase 1b aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, and immunogenicity in subjects with relapsed/refractory multiple myeloma and determine the recommended Phase 2 dose of AZD0120. Phase II aims to evaluate the efficacy of AZD0120, and to further characterize the safety, pharmacodynamic effects, immunogenicity, and changes in health-related quality of life parameters in subjects with relapsed/refractory multiple myeloma.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.