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)

Trial Title: 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)

NCT ID: NCT05885464

Condition: Lymphoblastic Lymphoma
T-Cell Lymphoblastic Leukemia/Lymphoma
Lymphoblastic Leukemia

Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Conditions: Keywords:
Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Base editing
CAR-T

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

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.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: BEAM-201
Description: A single dose of BEAM-201 administered by IV following one of two lymphodepletion regimens
Arm group label: Fludarabine, cyclophosphamide and alemtuzumab
Arm group label: Fludarabine, cyclophosphamide without alemtuzumab

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.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 50 Years

Healthy volunteers: No

Locations:

Facility:
Name: Stanford University School of Medicine

Address:
City: Stanford
Zip: 94304
Country: United States

Status: Recruiting

Facility:
Name: Colorado Blood Cancer Institute

Address:
City: Denver
Zip: 80218
Country: United States

Status: Recruiting

Facility:
Name: University of Chicago

Address:
City: Chicago
Zip: 60637
Country: United States

Status: Recruiting

Facility:
Name: The University of Kansas Cancer Center

Address:
City: Fairway
Zip: 66205
Country: United States

Status: Recruiting

Facility:
Name: Dana Farber and Boston Children's Hospital

Address:
City: Boston
Zip: 02115
Country: United States

Status: Recruiting

Facility:
Name: Cleveland Clinic- Taussig Cancer Center

Address:
City: Cleveland
Zip: 44106
Country: United States

Status: Recruiting

Facility:
Name: OHSU Knight Cancer Institute Hematology Oncology

Address:
City: Portland
Zip: 97239
Country: United States

Status: Recruiting

Facility:
Name: Children's Hospital of Philadelphia

Address:
City: Philadelphia
Zip: 19104
Country: United States

Status: Recruiting

Facility:
Name: Sarah Cannon- TriStar Bone Marrow Transplant

Address:
City: Nashville
Zip: 37203
Country: United States

Status: Recruiting

Facility:
Name: Methodist Hospital - Texas Transplant Institute

Address:
City: San Antonio
Zip: 78229
Country: United States

Status: Recruiting

Start date: May 25, 2023

Completion date: December 2031

Lead sponsor:
Agency: Beam Therapeutics Inc.
Agency class: Industry

Source: Beam Therapeutics Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05885464