A Phase 1b/2 Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B Cell Maturation Antigen in Participants With Relapsed or Refractory AL Amyloidosis.
Summary
Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.
Arms & interventions
- DrugAZD0120
Participants will receive AZD0120 via intravenous (IV) infusion.
Outcome measures
Primary
Phase 1b: Number of Participants With incidence and severity of Treatment-emergent Adverse Events
Time frame: Through study completion, a minimum of 6 months
Phase 2: Proportion of Participants Experiencing a Complete Response
Time frame: Through study completion, a minimum of 6 months
Secondary
Phase 1b: Levels of AZD0120 in blood over time in participants with AL amyloidosis
Time frame: Through study completion, a minimum of 6 months
Phase 2: Percentage of participants achieving hematologic response
Time frame: Through study completion, a minimum of 6 months
Eligibility criteria
Study locations (12)
Research Site
Phoenix, Arizona, 85028
Research Site
San Francisco, California, 94143
Research Site
Tampa, Florida, 33612
Research Site
Boston, Massachusetts, 02215
Research Site
Detroit, Michigan, 48201
Research Site
Rochester, Minnesota, 55905
Research Site
St Louis, Missouri, 63110
Research Site
New York, New York, 10016
Research Site
New York, New York, 10032
Research Site
New York, New York, 10065
Research Site
Cleveland, Ohio, 44195
Research Site
Nashville, Tennessee, 37232