RECRUITING

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

Conditions

Relapsed AL Amyloidosis Refractory AL Amyloidosis Light Chain Amyloidosis Amyloidosis AZD0120 AL Amyloidosis CAR-T Cell Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2025-08-18

Study Completion:2030-12-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07081646

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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)

Inclusion Criteria

Exclusion 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.

* 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)

Contacts and Locations

Study Contact

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

1-855-752-2356

clinicaltrials@alexion.com

Study Locations (Sites)

Research Site

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-18

Study Completion Date2030-12-19

Study Record Updates

Study Start Date2025-08-18

Study Completion Date2030-12-19

Terms related to this study

Keywords Provided by Researchers

AZD0120
Amyloidosis
AL Amyloidosis
CAR-T
Cell Therapy

Additional Relevant MeSH Terms

Relapsed AL Amyloidosis
Refractory AL Amyloidosis
Light Chain Amyloidosis
Amyloidosis