Relapsed AL AmyloidosisPhase 1/2ALACRITYNCT07081646
A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
A Phase 1/2 study testing AZD0120 in people with Relapsed AL Amyloidosis and Refractory AL Amyloidosis, run by Alexion Pharmaceuticals, Inc. at 18 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed AL Amyloidosis, Refractory AL Amyloidosis, Light Chain Amyloidosis
- What is being tested?
- AZD0120
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 18 Aug 2025to 14 Feb 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
18 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 3 countries
United States12 sites, 12 recruiting
- Recruiting
Research Site
Boston, Massachusetts, 02215
- Recruiting
Research Site
Cleveland, Ohio, 44195
- Recruiting
Research Site
Detroit, Michigan, 48201
- Recruiting
Research Site
Nashville, Tennessee, 37232
- Recruiting
Research Site
New York, New York, 10016
- Recruiting
Research Site
New York, New York, 10032
- Recruiting
Research Site
New York, New York, 10065
- Recruiting
Research Site
Phoenix, Arizona, 85028
- Recruiting
Research Site
Rochester, Minnesota, 55905
- Recruiting
Research Site
San Francisco, California, 94143
- Recruiting
Research Site
St Louis, Missouri, 63110
- Recruiting
Research Site
Tampa, Florida, 33612
Canada4 sites, 2 recruiting
- Withdrawn
Research Site
Calgary, Alberta, T2N 5G2
- Recruiting
Research Site
Calgary, Alberta, T2N 5G2
- Withdrawn
Research Site
Toronto, Ontario, M5G 2M9
- Recruiting
Research Site
Toronto, Ontario, M5G 2M9
United Kingdom2 sites, 1 recruiting
- Withdrawn
Research Site
London, NW3 2PF
- Recruiting
Research Site
London, NW3 2PF
About this study
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.
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.
- Being tested
- AZD0120
- Keywords
- AZD0120, AL Amyloidosis, CAR-T, Cell Therapy
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0120Drug
Participants will receive AZD0120 via intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| AZD0120 | Experimental | Participants will receive weight-based dose of AZD0120. Receives: Drug: AZD0120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Number of Participants With incidence and severity of Treatment-emergent Adverse Events
Measured: Through study completion, a minimum of 6 months
Phase 2: Proportion of Participants Achieving Complete Response
Measured: Through study completion, a minimum of 6 months
Secondary outcomes (2)
Phase 1b: Levels of AZD0120 in blood over time in participants with AL amyloidosis
Measured: Through study completion, a minimum of 6 months
Phase 2: Percentage of participants achieving hematologic response
Measured: Through study completion, a minimum of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start18 Aug 2025
- Primary completion15 Aug 2029 (estimated)
- Study completion14 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed AL AmyloidosisStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081646
- Sponsor's protocol ID
- D831AC00001
- Other IDs
- AZD0120-AL-201
- Acronym
- ALACRITY
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07081646
- Acronym / sponsor ID
- ALACRITY / D831AC00001
- Keywords
- AZD0120, AL Amyloidosis, CAR-T, Cell Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 15 Aug 2029 (estimated)
- Study completion
- 14 Feb 2031 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD0120 | Experimental | Drug: AZD0120Participants will receive weight-based dose of AZD0120. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0120Participants will receive AZD0120 via intravenous (IV) infusion. | Drug | AZD0120 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Yes. Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Related trials for Relapsed AL Amyloidosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD0120 in people with Relapsed AL Amyloidosis and Refractory AL Amyloidosis, run by Alexion Pharmaceuticals, Inc. at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexion Pharmaceuticals, Inc. (Sponsor) (1-855-752-2356, clinicaltrials@alexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b: Number of Participants With incidence and severity of Treatment-emergent Adverse Events (time frame: Through study completion, a minimum of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.