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BEAM-302

Phase 1

Alpha 1-Antitrypsin Deficiency | Small molecule | Rare Disease |Beam Therapeutics Inc.|Last Updated: Mar 20, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment106

FDA Designations

ORPHAN_DRUGRMAT

Clinical trial landscape

BEAM-302 · 1 trial · 1 indication

Phase 1 1
NCT06389877A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)Alpha 1-Antitrypsin Deficiency
RECRUITING106 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)
Alpha 1-Antitrypsin DeficiencyUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Numbers and percentages of patients reporting a given AE

Phase 2 Dose Expansion: Absolute blood levels of total AAT
2 Years

Absolute Levels of AAT over time

Secondary Endpoints

Phase 1 Dose Exploration: Absolute blood levels of total AAT
2 Years
Phase 2 Dose Expansion: Rates of TEAEs and SAEs
2 Years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BEAM-302 Drug ProductEXPERIMENTAL -

Interventions

NameTypeDescription
BEAM-302DRUGBEAM-302 is a lipid nanoparticle (LNP)-based therapy for the treatment of patients with AATD
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites11

Part A: Inclusion Criteria: * Males or females 18 - 70 years of age inclusive at the time of consent. * Diagnosis of AATD and homozygous for the PiZZ mutation (confirmed by genetic testing). * Blood total AAT level \<11 μM or equivalent protein in mg/dL. * Patients receiving augmentation therapy i...

Countries:United StatesAustraliaIrelandNetherlandsNew ZealandUnited Kingdom
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Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT06389877primaryCompletionDate: changed
LOWMay 24, 2026NCT06389877studyFirstPostDate: changed

Frequently asked questions about BEAM-302

What is BEAM-302 used for?

BEAM-302 is an investigational small molecule being developed for the treatment of Alpha 1-Antitrypsin Deficiency (AATD), a rare genetic condition. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug has received Orphan Drug and RMAT designations from the FDA.

Who is developing BEAM-302?

BEAM-302 is being developed by Beam Therapeutics Inc., a biotechnology company publicly traded under the ticker symbol BEAM. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of BEAM-302 in adult patients with Alpha 1-Antitrypsin Deficiency.

What phase is BEAM-302 in?

BEAM-302 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is actively recruiting participants and is designed to evaluate the safety and efficacy of BEAM-302 in adult patients with Alpha 1-Antitrypsin Deficiency.

What clinical trials is BEAM-302 in?

BEAM-302 is being studied in a Phase 1 clinical trial with the identifier NCT06389877. This trial is titled 'A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)' and is currently recruiting participants in the United States, Australia, Ireland, Netherlands, New Zealand, and the United Kingdom.

Is BEAM-302 FDA approved?

BEAM-302 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The FDA has granted BEAM-302 Orphan Drug and RMAT (Regenerative Medicine Advanced Therapy) designations, which are intended to expedite the development and review of promising therapies for serious conditions.