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BEAM-101

Phase 1

Sickle Cell Disease | Monoclonal antibody | Hematology |Beam Therapeutics Inc.|Last Updated: Dec 16, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

BEAM-101 · 1 trial · 1 indication

Phase 1 1
NCT05456880BEACON: A Study Evaluating the Safety and Efficacy of BEAM-101 in Patients With Severe Sickle Cell DiseaseSickle Cell Disease
ACTIVE NOT_RECRUITING15 Analytics
PHASE1ACTIVE NOT_RECRUITING
BEACON: A Study Evaluating the Safety and Efficacy of BEAM-101 in Patients With Severe Sickle Cell Disease
Sickle Cell DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in annualized number of severe VOCs (Vascular-occlusive Crisis) relative to baseline
6 months to time of analysis as compared to baseline
Proportion of patients with successful neutrophil engraftment
BEAM-101 administration to month 24
Time to neutrophil engraftment
BEAM-101 administration to month 24
Time to platelet engraftment
BEAM-101 administration to month 24
Transplant-related mortality within 100 days after beam-101 treatment
BEAM-101 administration to day 100
Safety and tolerability assessments based on frequency, severity and seriousness of adverse events (AE's)
BEAM-101 administration through month 24

Secondary Endpoints

Proportion of patients experiencing at least 75% reduction in annualized rate of severe VOCs
Month 6 post BEAM-101 treatment to month 24 as compared to baseline
Proportion of patients experiencing no severe VOCs
6 months to time of analysis as compared to baseline
Change in annualized number of hospitalizations for VOCs
Month 6 post BEAM-101 treatment to month 24 as compared to baseline
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BEAM-101EXPERIMENTALBEAM-101 manufactured with autologous CD34+ hematopoietic stem cells collected by plerixafor mobilization and edited ex vivo. No maximum dose has been set for BEAM-101; all of the gene edited cells that pass release specifications will be administered to the patient. BEAM 101 will be administered as a single dose by IV infusion.

Interventions

NameTypeDescription
BEAM-101BIOLOGICALSingle dose of BEAM-101 administered by IV following myeloablative conditioning with busulfan
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Eligibility Criteria

Age Range12 Years to 35 Years
SexALL
Healthy VolunteersNo
Study Sites19

Key Inclusion Criteria Include: 1. Age ≥12 years to ≤35 years 2. Documented diagnosis of sickle cell disease with βS/βS, βS/β0, or βS/β+ genotypes. 3. Severe SCD defined by the occurrence of at least 4 severe VOCs in the 24 months prior to screening despite receiving hydroxyurea or other supportive...

Countries:United States
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Frequently asked questions about BEAM-101

What is BEAM-101 used for in Sickle Cell Disease?

BEAM-101 is an investigational therapy being studied for the treatment of severe Sickle Cell Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in the BEACON study, which is assessing its safety and efficacy in patients with this condition.

Who makes BEAM-101?

BEAM-101 is being developed by Beam Therapeutics Inc., a biotechnology company publicly traded under the ticker symbol BEAM on the NASDAQ stock exchange. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Sickle Cell Disease.

What phase is BEAM-101 in?

BEAM-101 is currently in Phase 1 clinical development. It is an investigational drug and has not yet received approval from regulatory agencies. The ongoing Phase 1 study, known as BEACON, is actively evaluating the safety and efficacy of BEAM-101 in patients with severe Sickle Cell Disease.

What clinical trials is BEAM-101 in?

BEAM-101 is being studied in a Phase 1 clinical trial with the identifier NCT05456880. This trial, named BEACON, is evaluating the safety and efficacy of BEAM-101 in patients with severe Sickle Cell Disease. The study is active but not recruiting, with an enrollment target of 15 participants in the United States.

Is BEAM-101 FDA approved?

No, BEAM-101 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of severe Sickle Cell Disease. The drug is being evaluated in the BEACON clinical trial to assess its safety and efficacy, but it has not yet received regulatory approval.

What is the BEACON trial for BEAM-101?

The BEACON trial, identified as NCT05456880, is a Phase 1 study evaluating the safety and efficacy of BEAM-101 in patients with severe Sickle Cell Disease. This single-arm, open-label trial is being conducted in the United States and is currently active but not recruiting. The study aims to enroll 15 participants aged 12 years and older.