Clinical Trial 23773

• Overview

  Study Title:

  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.

  Objective:

  Phase 1b Objectives - Primary: *To evaluate the safety and tolerability of AZD0120, and determine the RP2D of AZD0120 in participants with AL amyloidosis Secondary: *To evaluate the efficacy of AZD0120 in participants with AL amyloidosis *To characterize the CK of AZD0120 in peripheral blood following a single-dose of AZD0120 in participants with AL amyloidosis *To assess immunogenicity of AZD0120 in participants with AL amyloidosis Phase 2 Objectives - Primary: *To evaluate the efficacy of AZD0120 in participants with AL amyloidosis Secondary: *To further evaluate the efficacy of AZD0120 in participants with AL amyloidosis *To characterize the safety of AZD0120 in participants with AL amyloidosis *To characterize the CK of AZD0120 in peripheral blood following a single-dose of AZD0120 in participants with AL amyloidosis *To assess immunogenicity of AZD0120 in participants with AL amyloidosis *To assess the effect of AZD0120 on overall health status in participants with AL amyloidosis

• Treatments

  Therapies:

  Cell Therapy

  Medications:

  AZD0120 ()

• Inclusion Criteria

  Key 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

  Key Exclusion Criteria:
  • Have any other form of amyloidosis other than AL amyloidosis
  • Mayo Stage IIIb AL amyloidosis
  • Oxygen saturation > Systolic blood pressure > 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 or Prior BCMA-targeting therapy or 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)

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