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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
A single dose of BEAM-201 administered by IV following one of two lymphodepletion regimens
Stanford University School of Medicine
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Chicago
Chicago, Illinois, United States
The University of Kansas Cancer Center
Fairway, Kansas, United States
Dana Farber and Boston Children's Hospital
Boston, Massachusetts, United States
Cleveland Clinic- Taussig Cancer Center
Cleveland, Ohio, United States
OHSU Knight Cancer Institute Hematology Oncology
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Sarah Cannon- TriStar Bone Marrow Transplant
Nashville, Tennessee, United States
Methodist Hospital - Texas Transplant Institute
San Antonio, Texas, United States
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)
Time frame: 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
Time frame: From treatment with BEAM-201 through study completion
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
Time frame: 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
Time frame: Through study completion, an average of 25 months
Duration of Response (DOR)
Time frame: Through study completion, an average of 25 months
Relapse-free survival (RFS)
Time frame: Through study completion, an average of 25 months
Overall survival
Time frame: Through study completion, an average of 25 months
Relapse-related mortality
Time frame: Through study completion, an average of 25 months
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