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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) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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)

NCT05885464•Beam Therapeutics Inc.

View on ClinicalTrials.gov

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

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

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:
+3 more criteria

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.

Locations (10)

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

Key Dates

Start Date

May 25, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

January 13, 2025

Enrollment

ACTUAL participants

Conditions

Lymphoblastic LymphomaT-Cell Lymphoblastic Leukemia/LymphomaLymphoblastic Leukemia

Interventions

BEAM-201

BIOLOGICAL

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

NCT05376111

T-cell Acute Lymphoblastic LeukemiaRecruiting

View study

RECRUITINGPHASE1

U69-CART-Cells For R/R T-ALL

NCT07350863

Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma

View study

RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

U69-CART-Cells For R/R T-ALL

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

Venetoclax Basket Trial for High Risk Hematologic Malignancies