NCT05885464

A 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)

A Phase 1/2, Dose-Exploration and Dose-Expansion Study Evaluating the Safety and Efficacy of Multiplex Base-Edited, Allogeneic Anti-CD7 CAR-T Cells (BEAM-201) in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Beam Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to \< 12 years), and a Phase 2 cohort.

Conditions

• Lymphoblastic Lymphoma
• T-Cell Lymphoblastic Leukemia/Lymphoma
• Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	BEAM-201	A single dose of BEAM-201 administered by IV following one of two lymphodepletion regimens

Timeline

• Start date: 2023-05-25
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-06-02
• Last updated: 2025-01-13

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study