Actively Recruiting
A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-03-24
91
Participants Needed
18
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed histopathological diagnosis of AL amyloidosis
- One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines
- Measurable hematologic disease with dFLC > 20 mg/L or serum M-protein > 5g/L
- Relapsed or refractory disease after at least one line of anti-plasma cell-directed therapy
- ECOG performance status of 0 to 1
- Ability and willingness to follow the study visit schedule and protocol requirements
- Women of child-bearing potential must have a negative pregnancy test before treatment
- All sexually active women of child-bearing potential and male subjects must agree to use effective birth control during the study
You will not qualify if you...
- Any form of amyloidosis other than AL amyloidosis
- Mayo Stage IIIb AL amyloidosis
- Oxygen saturation below 95% on room air
- Systolic blood pressure less than 100 mmHg
- New York Heart Association class III or IV heart failure
- Extensive gastrointestinal involvement with active bleeding or risk of bleeding
- Prior CAR T cell therapy targeting any antigen
- Prior BCMA-targeting therapy
- Prior treatment with FDA approved or investigational T cell engaging therapies within the last 6 months
- Unresolved toxicity from previous anti-cancer or anti-plasma cell therapy except alopecia or peripheral neuropathy
- Active plasma cell leukemia at screening
- Symptomatic multiple myeloma with ≥10% clonal bone marrow plasma cells plus myeloma-defining events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Research Site
Phoenix, Arizona, United States, 85028
Actively Recruiting
2
Research Site
San Francisco, California, United States, 94143
Not Yet Recruiting
3
Research Site
Tampa, Florida, United States, 33612
Actively Recruiting
4
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Research Site
Detroit, Michigan, United States, 48201
Actively Recruiting
6
Research Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Research Site
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Research Site
New York, New York, United States, 10016
Actively Recruiting
9
Research Site
New York, New York, United States, 10032
Actively Recruiting
10
Research Site
New York, New York, United States, 10065
Actively Recruiting
11
Research Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Research Site
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
Research Site
Calgary, Alberta, Canada, T2N 5G2
Withdrawn
14
Research Site
Calgary, Alberta, Canada, T2N 5G2
Not Yet Recruiting
15
Research Site
Toronto, Ontario, Canada, M5G 2M9
Withdrawn
16
Research Site
Toronto, Ontario, Canada, M5G 2M9
Not Yet Recruiting
17
Research Site
London, United Kingdom, NW3 2PF
Withdrawn
18
Research Site
London, United Kingdom, NW3 2PF
Not Yet Recruiting
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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