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

Sponsor: University of California, Davis

Sponsor score: 0

ClinicalTrials ID:NCT06854159

Provider View

This clinical trial is exploring how well the drug odronextamab works when given before and after CAR T-cell therapy in patients with diffuse large B-cell lymphoma (DLBCL) that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to test the effectiveness of odronextamab, a drug that helps the immune system target and kill cancer cells, in patients with diffuse large B-cell lymphoma (DLBCL) that has either come back or not responded to other treatments. The study will see if giving odronextamab before and after CAR T-cell therapy, a treatment that uses modified immune cells to attack cancer, can improve patient outcomes.

Description

The main goal of this study is to see how well odronextamab works with CAR T-cell therapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Researchers will also look at the side effects of this combination treatment.

Participants will receive odronextamab through an IV on specific days over several cycles. If the cancer does not show a complete response after a few cycles, patients may receive CAR T-cell therapy. Throughout the study, participants will undergo various tests, including heart scans and blood tests, to monitor their health and the treatment's effects.

After finishing the study treatment, participants will have follow-up visits to check their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
  • Have tried at least two previous treatments without success.
  • Have a life expectancy of at least 3 months.
  • Be eligible for FDA-approved CAR T-cell therapy.
  • Have a performance status score of 2 or lower, indicating they are able to carry out light work.
  • Meet specific blood count and organ function requirements.
  • For those with HIV, have a controlled infection with undetectable viral load and a CD4 count above 250.
  • For those with hepatitis B or C, have a controlled infection with no liver damage.
  • Agree to use effective birth control during the study and for 6 months after.
  • Be willing to provide informed consent.

Exclusion Criteria

  • Have any condition that poses a high risk or complicates the study results.
  • Have active or uncontrolled central nervous system lymphoma.
  • Have had another active cancer in the past 5 years, except for certain skin or cervical cancers.
  • Have an active infection that requires treatment.
  • Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Be on continuous high-dose steroid treatment.
  • Have had major surgery recently.
  • Have received certain treatments or vaccines recently.
  • Be pregnant or breastfeeding.
  • Have known allergies to specific medications used in the study.

Locations

FACILITYZIPCITYSTATE
University of California Davis Comprehensive Cancer Center95817SacramentoCalifornia

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