NCT07218887 ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy
| NCT ID | NCT07218887 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Condition | BAG3 Mutation Associated Dilated Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2025-10-24 |
| Primary Completion | 2032-01-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2025-10-24 with a primary completion date of 2032-01-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This Phase 1/2 study is an open-label, dose finding and dose expansion study investigating the safety, tolerability, and efficacy of a single IV infusion of ALXN2350 in adult participants with BAG3 associated DCM.
Eligibility Criteria
Inclusion Criteria: * Pathogenic or likely pathogenic mutation in BAG3 * Medical history of diagnosis of DCM * Stable combination of HF SoC medications * Adequate acoustic windows for echocardiography Exclusion Criteria: * Presence of antibodies to AAV9 * Presence of a pathogenic or likely pathogenic variant in another gene where that other gene is authoritatively recognized as causal for DCM. * Decompensated HF Note: Other inclusion and exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07218887 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying BAG3 Mutation Associated Dilated Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07218887 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07218887 currently recruiting?
Yes, NCT07218887 is actively recruiting participants. Contact the research team at clinicaltrials@alexion.com for enrollment information.
Where is the NCT07218887 trial being conducted?
This trial is being conducted at Birmingham, United States, Boston, United States, Cincinnati, United States, Portland, United States and 6 additional locations.
Who is sponsoring the NCT07218887 clinical trial?
NCT07218887 is sponsored by Alexion Pharmaceuticals, Inc.. The trial plans to enroll 6 participants.