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Clinical Trials in the USA / NCT05885464
Active, not recruiting Phase 1/2

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)

NCT05885464 · tracked via the Priya Life Science USA tracker
Sponsor
Beam Therapeutics Inc.
Phase
Phase 1/2
Started
2023-05-25
Last updated
2025-01-13

Condition(s) studied

Lymphoblastic LymphomaT-Cell Lymphoblastic Leukemia/LymphomaLymphoblastic Leukemia

Investigational drug(s) / intervention(s)

BEAM-201

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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 \[Clinical Laboratory Improvement Amendments of 1988\] certified facility) in second or greater relapse, first relapse post-transplant relapse, or chemotherapy-refractory disease. Specifically: 1. Second or greater relapse or post-transplant relapse, defined as: * BM with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease at screening after second documented CR; OR * Flow cytometric confirmation of relapsed T-ALL of at least 0.1% after second CR documented to have been MRD negative \< 0.1%; OR * Any detectable relapsed disease post-allogeneic HSCT with flow cytometric confirmation of T-ALL of at least 0.1%; OR * Biopsy confirmed evidence of relapsed T-LL on lymph node biopsy after second CR; OR * Any detectable disease post-allogeneic transplant with biopsy confirmed evidence of T-LL on lymph node biopsy 2. Refractory disease, defined as: * Primary refractory T-ALL or T-LL, defined as failure to achieve CR after induction chemotherapy, per investigator assessment and based on biopsy-confirmed evidence of residual T-ALL or T-LL; OR * Relapsed, refractory disease, defined as \> 5% BM blasts or biopsy-confirmed evidence of residual TLL after 1 course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR NOTE: Patients with mixed phenotype acute leukemia with T-cell dominant phenotype may be enrolled if the aforementioned criteria are met. 4. Eligible for myeloablative conditioning for and allogeneic HSCT based on the investigator's assessment with an available donor identified by a FACT accredited transplant center. Key Exclusion Criteria: 1. CNS involvement meeting any of the following criteria: CNS-3 disease, progressive CNS involvement despite therapy, CNS parenchymal or cranial nerve lesions on imaging. 2. Clinically active CNS dysfunction or known history of irreversible neurological toxicity related to prior antileukemic therapy. 3. Receipt of prior CD7 targeted therapy. 4. Systemic antileukemic therapy intended to induce or maintain remission within 14 days prior to completion of screening.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Stanford University School of Medicine Stanford California
Colorado Blood Cancer Institute Denver Colorado
University of Chicago Chicago Illinois
The University of Kansas Cancer Center Fairway Kansas
Dana Farber and Boston Children's Hospital Boston Massachusetts
Cleveland Clinic- Taussig Cancer Center Cleveland Ohio
OHSU Knight Cancer Institute Hematology Oncology Portland Oregon
Children's Hospital of Philadelphia Philadelphia Pennsylvania
Sarah Cannon- TriStar Bone Marrow Transplant Nashville Tennessee
Methodist Hospital - Texas Transplant Institute San Antonio Texas

More Beam Therapeutics Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05885464 on ClinicalTrials.gov ↗ ← All trials in the USA