At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AZD0120 (drug)
- How long the study runs
- Study runs about 66 months (dates as stated)
- About the drug or intervention
- AZD0120 — drug: Participants will receive AZD0120 via intravenous (IV) infusion.
- Patient visit burden
- Not specified by the sponsor
In plain English
This is an early-stage study (Phase 1b/2) of CAR T cell therapy (a treatment where your own immune cells are changed in a lab to attack cancer) targeting two proteins called CD19 and BCMA. It is for people whose AL amyloidosis (a rare condition where abnormal proteins build up in organs) has come back or has not responded to earlier treatment. The study is run by Alexion Pharmaceuticals, Inc.
Who can take part
- A confirmed diagnosis of AL amyloidosis based on tissue testing
- At least one organ affected by AL amyloidosis, now or in the past
- Measurable disease in the blood (dFLC over 20 mg/L or serum M-protein over 5 g/L)
- Disease has come back or not responded to at least one earlier treatment, and more treatment is needed
- Able to carry out daily activities with little or some effort (performance status 0 to 2)
- Able and willing to follow the study visit schedule
- Negative pregnancy test before treatment for women who can become pregnant, and highly effective birth control used throughout the study by all sexually active participants who can have children
Who may not be able to
- Any type of amyloidosis other than AL amyloidosis
- Mayo Stage IIIb AL amyloidosis (an advanced stage of the illness)
- Oxygen levels below 95% on room air
- Top blood pressure number (systolic) below 100 mmHg
- Severe heart failure symptoms (NYHA class III or IV)
- Extensive gut involvement with active bleeding or a high risk of bleeding
- Previous CAR T cell therapy of any kind
- Previous treatment targeting BCMA
- Treatment with any approved or experimental T cell engaging therapies (including bispecific or trispecific therapies) in the last 6 months
- Side effects from earlier cancer or plasma cell treatment that have not got better, except hair loss or nerve tingling/numbness
- Active plasma cell leukaemia at screening
- Symptomatic myeloma (bone marrow plasma cells of 10% or more plus at least one myeloma-defining event)
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about visit schedule, duration, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 91
- Started
- 2025-08-18
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for relapsed al amyloidosis
- • Phase1/Phase2 - 91 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with relapsed al amyloidosis
Where?
- • London - Research Site
- • London - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative serum and/or urine pregnancy test result
What the study is looking for
- ✓Confirmed histopathological diagnosis of AL amyloidosis
- ✓One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines
- ✓Measurable blood 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...
- ✓Fit enough for normal activity (ECOG 0) to 2
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (2 UK sites)
Research Site
London NW3 2PF, United Kingdom
Research Site
London NW3 2PF, United Kingdom
How to Get in Touch
Alexion Pharmaceuticals, Inc. (Sponsor)
Sponsor contactCONTACT
