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A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 2 → 3 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 4 more changesShow less
    • Enrollment increased: 106 → 192 participants
    • Study sites: 11 to 12
    • Eligibility criteria shortened, about 266 words
    • Secondary endpoints: 2 to 9
  2. Primary completion date: Jun 2027 to May 2028
    • Study sites: 6 to 11
    • Study completion date: Aug 2027 to May 2030
    v6
  3. Study sites: 5 to 6v5
  4. Study sites: 3 to 5v4
  5. Study sites: 1 to 3v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2024 to Jun 19, 2024
    • Site details revised
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 1/2, multicenter, open-label study conducted in 3 parts (Part A, Part B, and Part C) to evaluate the safety, tolerability, PK/PD, and efficacy of BEAM-302 in adult patients with AATD-associated lung disease and/or liver disease. Parts A and B are designed to evaluate safety and tolerability and identify the optimal biological dose (OBD) in patients with AATD-associated lung disease (Part A) and/or liver disease (Part B), with optional expansion cohorts to further evaluate a potential OBD. Part C is designed to demonstrate the efficacy and safety of BEAM-302 at the OBD in patients with AATD-associated lung disease with or without liver disease in the pivotal cohort.
Trial Details
NCT Number NCT06389877
Lead Sponsor Beam Therapeutics Inc.
Conditions
(from sponsor)		 Alpha 1-Antitrypsin Deficiency
Related terms alpha 1-Antitrypsin Deficiency
Enrollment 192 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov