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RecruitingInterventionalPhase 1/Phase 2

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.

NCT ID: NCT07081646Sponsor: Alexion Pharmaceuticals, Inc.Last updated: 2026-03-24

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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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. Exclusion Criteria: * 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: 1. CAR T cell therapy directed at any target 2. Prior BCMA-targeting therapy 3. 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)

Study locations (12)

Research Site

Phoenix, Arizona, 85028

Recruiting

Research Site

San Francisco, California, 94143

Not Yet Recruiting

Research Site

Tampa, Florida, 33612

Recruiting

Research Site

Boston, Massachusetts, 02215

Recruiting

Research Site

Detroit, Michigan, 48201

Recruiting

Research Site

Rochester, Minnesota, 55905

Recruiting

Research Site

St Louis, Missouri, 63110

Recruiting

Research Site

New York, New York, 10016

Recruiting

Research Site

New York, New York, 10032

Recruiting

Research Site

New York, New York, 10065

Recruiting

Research Site

Cleveland, Ohio, 44195

Recruiting

Research Site

Nashville, Tennessee, 37232

Recruiting