Study on Loncastuximab Tesirine and Rituximab Before CAR T-cell Therapy for Large B-cell Lymphoma

Sponsor: University of Utah

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06788964

This clinical trial is exploring whether the combination of Loncastuximab Tesirine and Rituximab is safe and effective as a preparatory treatment before standard CAR T-cell therapy in patients with large B-cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to determine if using Loncastuximab Tesirine and Rituximab before the standard CAR T-cell therapy is safe and can help treat patients with large B-cell lymphoma that has either come back after treatment or has not responded to previous therapies.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Planned to receive standard CD19-directed CAR T-cell therapy.
  • Need additional treatment before CAR T-cell therapy as decided by the doctor.
  • Have large B-cell lymphoma that has returned or not responded to at least one previous treatment.
  • Have measurable disease as shown by specific imaging tests.
  • Be in relatively good health with an ECOG performance status of 0 to 2.
  • Meet specific time requirements between previous cancer treatments and the first dose of the study drugs.
  • Have adequate organ function, including specific blood counts and liver and kidney function.
  • Women must not be pregnant and must meet certain criteria if they are of childbearing potential.
  • Agree to use effective contraception if of childbearing potential.
  • Be able to understand and sign an informed consent form.

Exclusion Criteria

  • Have had previous treatment with any anti-CD19 therapy or CAR T-cell therapy.
  • Are receiving investigational CAR T-cell products.
  • Have had major surgery within 4 weeks before starting the study.
  • Have a history of bleeding disorders or active bleeding.
  • Have severe liver disease.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have active graft-versus-host disease.
  • Have certain autoimmune diseases or other cancers that may affect safety or participation.
  • Have known involvement of the central nervous system by lymphoma.
  • Have significant medical conditions that could increase risks or affect participation.
  • Have active infections requiring treatment at the time of screening.
  • Have HIV infection.
  • Have active hepatitis B or C infections unless specific conditions are met.
  • Have severe allergies to study drugs or their components.
  • Are taking medications that are not allowed during the study.

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