106 Participants NeededMy employer runs this trial

BEAM-302 for Alpha-1 Antitrypsin Deficiency

Recruiting at 10 trial locations
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Beam Therapeutics Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BEAM-302 for individuals with Alpha-1 Antitrypsin Deficiency (AATD), a condition that can lead to lung and liver problems. The study aims to determine the safety and effectiveness of BEAM-302 and identify the optimal dose. It seeks participants diagnosed with AATD who have specific lung or liver issues, such as emphysema or certain levels of liver fibrosis. Eligible participants should not have undergone a lung or liver transplant or have severe lung or liver conditions. This trial might be suitable for those meeting these criteria. As a Phase 1, Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Is there any evidence suggesting that BEAM-302 is likely to be safe for humans?

Research has shown that BEAM-302 has a good safety record in clinical trials. Patients who took doses up to 75 mg mostly experienced mild to moderate side effects. Importantly, no reports indicated serious side effects or issues that would prevent higher dosing. This suggests that participants tolerated the treatment well. These findings imply that BEAM-302 could be a safe option for treating alpha-1 antitrypsin deficiency, although further research is needed to confirm these results.12345

Why do researchers think this study treatment might be promising?

Most treatments for Alpha-1 Antitrypsin Deficiency rely on augmenting the body's deficient enzyme with infusions of alpha-1 antitrypsin protein derived from human plasma. But BEAM-302 offers something different. It uses gene editing technology to precisely target and correct the faulty gene responsible for the deficiency, potentially providing a more permanent solution. Researchers are excited because this approach could reduce the need for frequent infusions and directly address the root cause of the condition, rather than just managing its symptoms.

What evidence suggests that BEAM-302 might be an effective treatment for Alpha-1 Antitrypsin Deficiency?

Research has shown that BEAM-302 holds promise for treating alpha-1 antitrypsin deficiency (AATD). In studies, a single dose of BEAM-302 increased levels of healthy alpha-1 antitrypsin protein and reduced the harmful mutated protein by 84%. Patients who received 60 mg of BEAM-302 consistently maintained healthy protein levels above the target, averaging 16.1 µM. After treatment, 94% of the alpha-1 antitrypsin in the blood was corrected. These results suggest that BEAM-302 may effectively address the root cause of lung and liver disease related to AATD by improving protein levels.12567

Who Is on the Research Team?

MI

Medical Information

Principal Investigator

Beam Therapeutics

Are You a Good Fit for This Trial?

Inclusion Criteria

My lung function tests show moderate airflow limitation.
I have AATD and two copies of the PiZZ gene mutation.
My blood AAT levels are below the normal range.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Exploration

Participants receive BEAM-302 to evaluate safety, tolerability, PK/PD, and efficacy

2 years

Phase 2 Dose Expansion

Participants receive BEAM-302 to determine the optimal biological dose

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BEAM-302

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: BEAM-302 Drug ProductExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beam Therapeutics Inc.

Lead Sponsor

Trials
5
Recruited
1,200+

Citations

Press Release

Treatment with 60 mg of BEAM-302 Led to Mean Steady-state Total AAT Level of 16.1 µM and All Patients Consistently and Durably Above the 11 ...

Beam Therapeutics Announces Update on BEAM-302

Mutant Z-AAT was durably and significantly reduced after treatment with BEAM-302. The steady-state mean reduction in Z-AAT was 84% in the 60 mg ...

A cure for alpha-1? Novel therapeutics in alpha-1 antitrypsin ...

In early results from an ongoing phase 1/2 clinical trial (NCT06389877), a single intravenous dose of BEAM-302 led to durable, dose-dependent increases in total ...

A Study to Evaluate the Safety and Efficacy of BEAM-302 in ...

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

Beam Therapeutics Reports Clinical Proof-Of-Concept ...

In patients with alpha-1 antitrypsin deficiency, a single treatment of BEAM-302 increased the levels of healthy protein and reduced harmful mutated protein by ...

Beam Therapeutics Reports First Quarter 2026 Financial ...

Recent BEAM-302 Topline Data in Alpha-1 Antitrypsin Deficiency (AATD) Demonstrate Strong Single-dose Safety and Efficacy Profile, with 60 mg ...

Initial Clinical Data for BEAM-302 in Alpha-1 Antitrypsin ...

302 in alpha-1 antitrypsin deficiency. (AATD) → Initial data today. • Potential one-time treatment for. AATD lung and liver manifestations.