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Phase 1b/2 Study of CAR T Cell Therapy for Relapsed or Refractory AL Amyloidosis

This study is testing a treatment called AZD0120, a type of CAR T cell therapy, for people with AL amyloidosis (a rare disease where abnormal proteins build up in organs) that has come back or isn't responding to other treatments. The study aims to see how safe and effective AZD0120 is. To join, you must have a confirmed diagnosis of AL amyloidosis affecting one or more organs, and your disease must be measurable and have returned or not responded after at least one previous treatment. For the study to be considered successful, researchers are looking at how many participants experience side effects and how many achieve a complete response to the treatment. The current recruitment status is unclear.

Study design
This is an open-label Phase 1b/2 study, meaning you and your doctors will know what treatment you are receiving. The study plans to enroll 91 participants.
What's involved
Participants will receive AZD0120 through an intravenous (IV) infusion. The trial record does not specify the number of visits or other procedures.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which will be a minimum of 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07081646

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Alexion Pharmaceuticals, Inc.
~91 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:AZD0120

At a glance

Recruiting sites
15 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1b: Number of Participants With incidence and severity of Treatment-emergent Adverse Events
Measured over Through study completion, a minimum of 6 months
+1 more outcome measured

Conditions

Relapsed AL Amyloidosis
Refractory AL Amyloidosis
Light Chain Amyloidosis
Amyloidosis

Explore related trials

Primary AmyloidosisCD19 Gene

Where it's being run

18 sites across 13 states
New York3
Alberta2
Ontario2
United Kingdom2
Arizona1
California1
Florida1
Massachusetts1

Who to contact

Alexion Pharmaceuticals, Inc. (Sponsor)
[email protected]
1-855-752-2356
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
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)

What this trial measures

  • Phase 1b: Number of Participants With incidence and severity of Treatment-emergent Adverse EventsThrough study completion, a minimum of 6 months
  • Phase 2: Proportion of Participants Achieving Complete ResponseThrough study completion, a minimum of 6 months