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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Beam Therapeutics Inc.
Study ID
NCT06389877
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Alpha 1-Antitrypsin Deficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • BEAM-302 — DRUG
    BEAM-302 is a lipid nanoparticle (LNP)-based therapy for the treatment of patients with AATD

Study Details

This is a Phase 1/2, multicenter, open-label, dose-exploration (Phase 1) and dose-expansion (Phase 2) study to evaluate the safety, tolerability, PK/PD, and efficacy of BEAM-302 in adult patients with AATD-associated lung disease and/or liver disease and to determine the optimal biological dose (OBD).

Key Dates

Start date
Jun 19, 2024
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
May 31, 2030

Study Design

Enrollment
106 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BEAM-302 Drug Product

Primary Outcome Measure

Phase 1 Dose Exploration: Rates of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical Study CenterBirminghamAlabama35233-
Clinical Study CenterBostonMassachusetts02215-
Clinical Study CenterCharlestonSouth Carolina29425-

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