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BEAM-201

Phase 1

Lymphoblastic Lymphoma | Monoclonal antibody | Oncology |Beam Therapeutics Inc.|Last Updated: Jan 13, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05885464A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL)PHASE1 ACTIVE NOT_RECRUITING 5 — — May 25, 2023Dec 1, 2026Jan 13, 202510 United States
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Study Endpoints
Primary Endpoints
Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events, including serious adverse events (SAEs) and dose-limiting toxicities (DLTs; in Phase 1 only)
Through study completion, an average of 25 months
Overall response rate as defined as proportion of T-ALL patients achieving complete response (CR) or complete response with incomplete hematologic recovery (CRi) or T-LL patients achieving CR or PR at any point after BEAM-201 infusion
From treatment with BEAM-201 through study completion
Secondary Endpoints
Proportion of patients who achieve MRD negative response (defined as < 0.1%) by flow cytometry or next generation sequencing (NGS) in patients achieving morphologic response
Starting at Day 28 and multiple time points up to Month 24
Proportion of patients treated with BEAM-201 deemed appropriate for HSCT based on investigator assessment of clinical response
Through study completion, an average of 25 months
Duration of Response (DOR)
Through study completion, an average of 25 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Fludarabine, cyclophosphamide and alemtuzumabEXPERIMENTALLymphodepletion regimen including fludarabine, cyclophosphamide and alemtuzumab
Fludarabine, cyclophosphamide without alemtuzumabEXPERIMENTALLymphodepletion regimen without Alz but consisting of the same dose of Flu/Cy as in the other arm
Interventions
NameTypeDescription
BEAM-201BIOLOGICALA single dose of BEAM-201 administered by IV following one of two lymphodepletion regimens
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites10

Key Inclusion Criteria: 1. Ages 18 to ≤ 50 years. 2. Ages ≥ 1 year to \< 18 years, after health authority approval. 3. T-ALL/T-LL that is CD7-positive (defined as at least 20% of blasts positive for CD7 by flow cytometry or immunohistochemistry based on assessment of the study site's CLIA \[Clinica...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05885464primaryCompletionDate: changed
LOWMay 24, 2026NCT05885464studyFirstPostDate: changed