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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)

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ClinicalTrials.gov Identifier: NCT05885464
Recruitment Status : Recruiting
First Posted : June 2, 2023
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Beam Therapeutics Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoblastic Lymphoma T-Cell Lymphoblastic Leukemia/Lymphoma Lymphoblastic Leukemia Biological: BEAM-201 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The maximum number of patients for this study is approximately 102 patients:

  • 36 patients in the Phase 1 dose exploration
  • approximately 12 patients in the Phase 1 dose-expansion cohorts
  • 6 patients in the pediatric cohort
  • approximately 48 patients in the Phase 2 cohort.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 25, 2023
Estimated Primary Completion Date : December 2031
Estimated Study Completion Date : December 2031

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Fludarabine, cyclophosphamide and alemtuzumab
Lymphodepletion regimen including fludarabine, cyclophosphamide and alemtuzumab
 Biological: BEAM-201
A single dose of BEAM-201 administered by IV following one of two lymphodepletion regimens
Experimental: Fludarabine, cyclophosphamide without alemtuzumab
Lymphodepletion regimen without Alz but consisting of the same dose of Flu/Cy as in the other arm
 Biological: BEAM-201
A single dose of BEAM-201 administered by IV following one of two lymphodepletion regimens


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Duration of Response (DOR) [ Time Frame: Through study completion, an average of 25 months ]
  4. Relapse-free survival (RFS) [ Time Frame: Through study completion, an average of 25 months ]
  5. Overall survival [ Time Frame: Through study completion, an average of 25 months ]
  6. Relapse-related mortality [ Time Frame: Through study completion, an average of 25 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05885464


Contacts
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Contact: Medical Information 857-327-8641 clinicalinfo@beamtx.com

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94304
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Kansas
The University of Kansas Cancer Center Recruiting
Fairway, Kansas, United States, 66205
United States, Ohio
Cleveland Clinic- Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon- TriStar Bone Marrow Transplant Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Methodist Hospital - Texas Transplant Institute Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Beam Therapeutics Inc.
More Information
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Responsible Party: Beam Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05885464    
Other Study ID Numbers: BTX-ALO-001
First Posted: June 2, 2023    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beam Therapeutics Inc.:
Lymphoblastic Leukemia
Lymphoblastic Lymphoma
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CAR-T
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases