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Dual-target CAR T therapy (CD19 and BCMA) for relapsed or refractory AL (light-chain) amyloidosis

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.

Phase1; Phase2 Interventional Alexion Pharmaceuticals, Inc. · NCT07081646

This trial will try AZD0120, a CAR T cell therapy that targets CD19 and BCMA, to see if it is safe and helps people with relapsed or refractory AL (light-chain) amyloidosis.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment91 (estimated)
Ages18 Years and up
SexAll
SponsorAlexion Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionsCAR T
Locations18 sites (Phoenix, Arizona and 17 other locations)
Trial IDNCT07081646 on ClinicalTrials.gov

What this trial studies

This open-label Phase 1b/2 trial tests AZD0120, a CAR T product engineered to target both CD19 and BCMA, in adults with relapsed or refractory AL (light-chain) amyloidosis. Phase 1b focuses on dose-finding and safety/tolerability while Phase 2 expands evaluation of hematologic and organ responses. Eligible participants must have biopsy-confirmed AL amyloidosis with measurable disease (dFLC >20 mg/L or serum M-protein >5 g/L), prior anti-plasma cell therapy, and ECOG 0–1, while patients with advanced cardiac disease (Mayo Stage IIIb) or significant cardiopulmonary compromise are excluded. The trial is sponsored by Alexion and run at selected US sites, with on-site procedures including leukapheresis, conditioning, infusion, and close post-infusion monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults with biopsy-confirmed AL amyloidosis who have measurable disease (dFLC >20 mg/L or serum M-protein >5 g/L), have relapsed or are refractory after at least one line of anti-plasma cell therapy, and have ECOG performance status 0–1.

Not a fit: Patients with non‑AL forms of amyloidosis, advanced cardiac involvement (Mayo Stage IIIb), low oxygenation or blood pressure, or poor overall cardiopulmonary status are unlikely to be eligible or to benefit from this therapy.

Why it matters

Potential benefit: If successful, AZD0120 could produce deeper hematologic remissions and meaningful organ responses for people with relapsed or refractory AL amyloidosis.

How similar studies have performed: CAR T therapies targeting BCMA (and in some cases CD19) have shown promising hematologic responses in plasma-cell disorders such as multiple myeloma, and early small studies in AL amyloidosis have reported encouraging but preliminary results.

Eligibility criteria

Show full inclusion / exclusion 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 disease or refractory disease defined as a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
* ECOG performance status of 0 to 1
* 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 pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use 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:

  1. CAR T cell therapy directed at any target
  2. Prior BCMA-targeting therapy
  3. 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)

Where this trial is running

Phoenix, Arizona and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed AL AmyloidosisRefractory AL AmyloidosisLight Chain AmyloidosisAmyloidosisAZD0120AL AmyloidosisCAR-TCell Therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.