Menu
Recruiting NCT07081646

A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.

Phase I / Phase II Interventional Relapsed AL Amyloidosis Refractory AL Amyloidosis Light Chain Amyloidosis Amyloidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AZD0120.
Who it may be relevant to
Registry conditions: Relapsed AL Amyloidosis, Refractory AL Amyloidosis, Light Chain Amyloidosis, Amyloidosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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.

Interventions

  • Drug AZD0120
    Participants will receive AZD0120 via intravenous (IV) infusion.

Primary outcome measures

  • 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 Achieving Complete Response [Time frame: Through study completion, a minimum of 6 months]
Secondary outcome measures (2)
  • 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

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 or refractory disease with a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
  • ECOG performance status of 0 to 2
  • 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 and/or urine pregnancy test result prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use highly 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:
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Research Site — Phoenix
  • Research Site — San Francisco
  • Research Site — Tampa
  • Research Site — Boston
  • Research Site — Detroit
  • Research Site — Rochester
  • Research Site — St Louis
  • Research Site — New York
  • … and 4 more centers
Canada · 4 centers
  • Research Site — Calgary
  • Research Site — Calgary
  • Research Site — Toronto
  • Research Site — Toronto
United Kingdom · 2 centers
  • Research Site — London
  • Research Site — London

Identifiers

NCT: NCT07081646 · D831AC00001 · AZD0120-AL-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗