Study on Odronextamab for Treating Relapsed and Hard-to-Treat Large B-cell Lymphomas Before CAR-T Therapy

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT06784726

Provider View

This clinical trial is exploring the use of odronextamab, a special type of antibody, as a bridging treatment before CAR-T cell therapy in patients with large B-cell lymphomas that have returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to test if odronextamab, a bispecific antibody, can help control large B-cell lymphomas that have come back or are resistant to treatment. Odronextamab works by attaching to two different targets: CD3 on T-cells and CD20 on B-cells, which are often found in B-cell cancers. This study aims to see if using odronextamab before CAR-T cell therapy can help delay the progression of the disease, allowing for successful CAR-T treatment in patients with relapsed or refractory large B-cell lymphomas.

Description

In this study, patients will receive odronextamab through an IV on specific days over several cycles. The first cycle involves doses on days 1, 2, 8, 9, 15, and 16, followed by doses on days 1, 8, and 15 in the next cycles. After two cycles, patients will undergo a process called leukapheresis, followed by CAR-T cell therapy. If there are delays, patients may receive additional treatment. Patients who show complete response after two cycles may choose to continue with odronextamab without moving to CAR-T therapy. Throughout the study, patients will have various tests, including PET/CT scans, blood tests, and possibly biopsies, to monitor their health and the treatment's effectiveness. After finishing the treatment, patients will be followed for up to five years to check for any side effects and the overall outcome of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of large B-cell lymphoma, such as diffuse large B-cell lymphoma or follicular lymphoma grade 3B.
  • Have at least one tumor that can be measured by scans.
  • Previous treatments for large B-cell lymphoma have not worked.
  • Eligible for certain CAR-T cell therapies approved by the FDA.
  • Aged 18 years or older.
  • Able to understand and sign a consent form.
  • Previously treated with anti-CD20 antibody therapy.
  • Good overall health with a performance status score of 0-1, or 2 if related to lymphoma.
  • Adequate kidney, liver, lung, and heart function as determined by specific medical tests.
  • Sufficient blood cell counts.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men and women must agree to use effective birth control during the study and for six months after CAR-T therapy.
  • No egg or sperm donation during and for six months after the study.

Exclusion Criteria

  • Cancer cells in the brain or spinal fluid, or history of such conditions.
  • History of seizures, strokes, or certain brain diseases.
  • Recent chemotherapy or radiation therapy.
  • Previous treatment with similar bispecific therapies or CAR-T cell therapy.
  • Participation in other clinical trials or investigational treatments.
  • Allergies to similar drugs or tetracycline antibiotics.
  • Active infections or other serious medical conditions.
  • Use of certain medications or treatments that could interfere with the study.
  • Pregnant or breastfeeding women.
  • Recent live vaccinations.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.