NCT05885464

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)

Study 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.

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Interventions

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

Study Locations

FacilityCityStateCountry
Stanford University School of MedicineStanfordCaliforniaUnited States
Colorado Blood Cancer InstituteDenverColoradoUnited States
University of ChicagoChicagoIllinoisUnited States
The University of Kansas Cancer CenterFairwayKansasUnited States
Dana Farber and Boston Children's HospitalBostonMassachusettsUnited States
Cleveland Clinic- Taussig Cancer CenterClevelandOhioUnited States
OHSU Knight Cancer Institute Hematology OncologyPortlandOregonUnited States
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
Sarah Cannon- TriStar Bone Marrow TransplantNashvilleTennesseeUnited States
Methodist Hospital - Texas Transplant InstituteSan AntonioTexasUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026