A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
ALACRITY
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.
2 other identifiers
interventional
91
3 countries
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2025
Longer than P75 for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedStudy Start
First participant enrolled
August 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 14, 2031
March 24, 2026
March 1, 2026
4 years
July 7, 2025
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1b: Number of Participants With incidence and severity of Treatment-emergent Adverse Events
Through study completion, a minimum of 6 months
Phase 2: Proportion of Participants Experiencing a Complete Response
Through study completion, a minimum of 6 months
Secondary Outcomes (2)
Phase 1b: Levels of AZD0120 in blood over time in participants with AL amyloidosis
Through study completion, a minimum of 6 months
Phase 2: Percentage of participants achieving hematologic response
Through study completion, a minimum of 6 months
Study Arms (1)
AZD0120
EXPERIMENTALParticipants will receive weight-based dose of AZD0120.
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed histopathological diagnosis of AL amyloidosis
- One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines
- Measurable hematologic disease: dFLC \> 20 mg/L or serum M-protein \> 5g/L
- Relapsed disease or refractory disease defined as a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
- ECOG performance status of 0 to 1
- Must be able and willing to adhere to the study visit schedule and other protocol requirements
- Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.
You may not qualify if:
- Have any other form of amyloidosis other than AL amyloidosis
- Mayo Stage IIIb AL amyloidosis
- Oxygen saturation \< 95% on room air
- Systolic blood pressure \<100mmHg
- NYHA class III or IV
- Extensive GI involvement with evidence of active GI bleeding/risk of bleeding as determined by Investigator
- Prior therapies:
- CAR T cell therapy directed at any target
- Prior BCMA-targeting therapy
- Prior treatment with any FDA approved or investigational T cell engaging therapies (including T cell-directed bispecific or trispecific therapies) at any target within the last 6 months.
- Toxicity from previous anti-cancer or anti-PC-directed therapy did not resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
- Active plasma cell leukemia at the time of screening
- Symptomatic multiple myeloma (defined as clonal bone marrow plasma cells ≥10% plus at least one myeloma-defining event per IMWG 2014)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Research Site
Phoenix, Arizona, 85028, United States
Research Site
San Francisco, California, 94143, United States
Research Site
Tampa, Florida, 33612, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
New York, New York, 10016, United States
Research Site
New York, New York, 10032, United States
Research Site
New York, New York, 10065, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Nashville, Tennessee, 37232, United States
Research Site
Calgary, Alberta, T2N 5G2, Canada
Research Site
Calgary, Alberta, T2N 5G2, Canada
Research Site
Toronto, Ontario, M5G 2M9, Canada
Research Site
Toronto, Ontario, M5G 2M9, Canada
Research Site
London, NW3 2PF, United Kingdom
Research Site
London, NW3 2PF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2025
First Posted
July 23, 2025
Study Start
August 18, 2025
Primary Completion (Estimated)
August 15, 2029
Study Completion (Estimated)
February 14, 2031
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.