Study on the Safety and Effectiveness of BEAM-201 for Treating Relapsed or Hard-to-Treat T-Cell Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma

Sponsor: Beam Therapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05885464

Provider View

This clinical trial is testing a new treatment called BEAM-201 to see if it is safe and effective for patients with T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL) that has returned after treatment or is difficult to treat.

Patient Parameters

Program Overview

This study is being conducted to evaluate the safety and effectiveness of a new treatment called BEAM-201 for patients with T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL) that has either come back after treatment or is resistant to current treatments. The study is divided into different phases, including initial testing to find the right dose, expanding the study to more patients, and including a group of children aged 1 to under 12 years. The study will take place at multiple centers and is open to eligible patients.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 50 years.
  • Children aged 1 to under 18 years, after approval from health authorities.
  • Diagnosed with T-ALL or T-LL that is CD7-positive, meaning a specific marker is present on the cancer cells.
  • The cancer has returned after treatment or is not responding to current treatments, including:
    • Cancer has returned after a second or more relapses, or after a transplant.
    • Cancer is not responding to chemotherapy.
  • Eligible for a specific type of intensive treatment and transplant, with a suitable donor available.

Exclusion Criteria

  • Cancer has spread to the brain or spinal cord, or there are worsening symptoms despite treatment.
  • Active brain or nerve problems, or past severe nerve damage from leukemia treatment.
  • Previously received treatment targeting CD7.
  • Received leukemia treatment aimed at remission within 14 days before completing screening.

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