Study on Golcadomide and Nivolumab for Non-Hodgkin Lymphoma After CAR-T Therapy

Sponsor: Natalie Galanina

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06767956

Provider View

This clinical trial is testing a new combination of drugs, Golcadomide and Nivolumab, to see if they are safe and effective for patients with Non-Hodgkin Lymphoma that hasn't responded well after CAR-T cell therapy.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of combining Golcadomide and Nivolumab in patients with Non-Hodgkin Lymphoma (NHL) who still have active disease after receiving CAR-T cell therapy. The trial will start with testing different doses to find the safest and most effective one, followed by expanding the study to more patients.

Description

Non-Hodgkin Lymphoma (NHL) is a type of cancer that affects the lymphatic system, with many new cases each year. Some common types include diffuse large B-cell lymphoma (DLBCL). The survival rate can vary based on factors like the stage of the disease and the patient's overall health. This study is exploring a new treatment approach using Golcadomide and Nivolumab, especially for patients whose cancer has not responded well to previous treatments like CAR-T cell therapy. The goal is to see if this combination can help the immune system fight the cancer more effectively. Researchers hope to achieve a response rate of 45% or more, with manageable side effects, to consider this treatment for further research.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of high-grade large B-cell lymphoma, such as DLBCL or similar types.
  • Have measurable disease that can be seen on scans.
  • Have received FDA-approved CAR-T cell therapy and still have active disease 30 days to 1 year after treatment.
  • Be in good general health with an ECOG performance status of 0 to 2.
  • Have adequate organ and bone marrow function.
  • HIV-positive patients must be on effective treatment with undetectable viral load.
  • Patients with hepatitis B or C must have undetectable viral load on treatment.
  • Patients with cancer spread to the brain are eligible if it is part of the systemic disease.
  • Patients with other cancers that do not interfere with this study are eligible.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 28 days after the last dose.
  • Must be able to take oral medication and follow the treatment plan.

Exclusion Criteria

  • Have received other cancer treatments after CAR-T therapy, except for palliative radiation.
  • Have not fully recovered from side effects of previous cancer treatments, except for hair loss.
  • Have allergies to the study drugs.
  • Have medical or psychiatric conditions that may affect participation in the study.
  • Have digestive issues that affect absorption of oral medication.
  • Have active autoimmune diseases.
  • Are taking strong medications that affect the liver enzyme CYP3A, unless they can stop them for at least 14 days before starting the study.
  • Are currently breastfeeding.

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