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)

Last updated: January 10, 2025
Sponsor: Beam Therapeutics Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Lymphoma

Leukemia

Lymphoproliferative Disorders

Treatment

BEAM-201

Clinical Study ID

NCT05885464
BTX-ALO-001
  • Ages 18-50
  • All Genders

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 Criteria

Inclusion

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 CD7by flow cytometry or immunohistochemistry based on assessment of the study site'sCLIA [Clinical Laboratory Improvement Amendments of 1988] certified facility) insecond or greater relapse, first relapse post-transplant relapse, orchemotherapy-refractory disease. Specifically:

  4. Second or greater relapse or post-transplant relapse, defined as:

  • BM with ≥ 5% lymphoblasts by morphologic assessment or evidence ofextramedullary disease at screening after second documented CR; OR
  • Flow cytometric confirmation of relapsed T-ALL of at least 0.1% aftersecond CR documented to have been MRD negative < 0.1%; OR
  • Any detectable relapsed disease post-allogeneic HSCT with flow cytometricconfirmation of T-ALL of at least 0.1%; OR
  • Biopsy confirmed evidence of relapsed T-LL on lymph node biopsy aftersecond CR; OR
  • Any detectable disease post-allogeneic transplant with biopsy confirmedevidence of T-LL on lymph node biopsy
  1. Refractory disease, defined as:
  • Primary refractory T-ALL or T-LL, defined as failure to achieve CR afterinduction chemotherapy, per investigator assessment and based onbiopsy-confirmed evidence of residual T-ALL or T-LL; OR
  • Relapsed, refractory disease, defined as > 5% BM blasts orbiopsy-confirmed evidence of residual TLL after 1 course of re-inductionchemotherapy for patients who have relapsed after previously achieving aCR NOTE: Patients with mixed phenotype acute leukemia with T-cell dominantphenotype may be enrolled if the aforementioned criteria are met.
  1. Eligible for myeloablative conditioning for and allogeneic HSCT based on theinvestigator's assessment with an available donor identified by a FACT accreditedtransplant center.

Exclusion

Key Exclusion Criteria:

  1. CNS involvement meeting any of the following criteria: CNS-3 disease, progressiveCNS involvement despite therapy, CNS parenchymal or cranial nerve lesions onimaging.

  2. Clinically active CNS dysfunction or known history of irreversible neurologicaltoxicity related to prior antileukemic therapy.

  3. Receipt of prior CD7 targeted therapy.

  4. Systemic antileukemic therapy intended to induce or maintain remission within 14days prior to completion of screening.

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: BEAM-201
Phase: 1/2
Study Start date:
May 25, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Stanford University School of Medicine

    Stanford, California 94304
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Colorado Blood Cancer Institute - SCRI - PPDS

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • The University of Kansas Cancer Center

    Fairway, Kansas 66205
    United States

    Site Not Available

  • Dana Farber and Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Cleveland Clinic- Taussig Cancer Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • OHSU Knight Cancer Institute Hematology Oncology

    Portland, Oregon 97239
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Sarah Cannon- TriStar Bone Marrow Transplant

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Methodist Hospital - Texas Transplant Institute

    San Antonio, Texas 78229
    United States

    Site Not Available

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