CAR-T Cell Therapy, Mosunetuzumab, and Polatuzumab for Treating Hard-to-Treat Aggressive Non-Hodgkin's Lymphoma (NHL)

Sponsor: Lazaros Lekakis

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05260957

Provider View

This study aims to see if a combination of CAR-T cell therapy, Mosunetuzumab, and Polatuzumab Vedotin can help shrink tumors in patients with aggressive Non-Hodgkin's Lymphoma that hasn't responded to other treatments.

Patient Parameters

Program Overview

This clinical trial is testing a new treatment approach for patients with aggressive Non-Hodgkin's Lymphoma (NHL) that has not responded to previous treatments or has returned after treatment. The study combines three therapies: CAR-T cell therapy, Mosunetuzumab, and Polatuzumab Vedotin, to see if they can work together to reduce the size of tumors. The trial is open to adults with specific types of NHL, and participants will need to meet certain health criteria to join.

Description

This clinical trial is designed for patients with aggressive Non-Hodgkin's Lymphoma (NHL) that has either not responded to previous treatments or has come back after treatment. The study will test a combination of three therapies: CAR-T cell therapy, Mosunetuzumab, and Polatuzumab Vedotin. CAR-T cell therapy involves modifying a patient's own immune cells to better fight cancer. Mosunetuzumab and Polatuzumab Vedotin are drugs that target specific proteins on cancer cells. The goal is to see if this combination can effectively reduce tumor size. Participants will need to meet specific health criteria and agree to regular check-ups and procedures as part of the study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with certain types of aggressive Non-Hodgkin's Lymphoma, such as Diffuse Large B Cell Lymphoma, Primary Mediastinal B Cell Lymphoma, Transformed Follicular Lymphoma, High Grade B Cell Lymphoma, Mantle Cell Lymphoma, or Burkitt Lymphoma.
  • The lymphoma must be either not responding to initial treatments or have returned after treatment.
  • At least one tumor that can be measured.
  • Lymphoma cells must be CD19 positive.
  • Must be an adult aged 18 to 80 years.
  • Must have certain levels of kidney function, liver function, heart function, and oxygen levels.
  • Must not have received certain blood transfusions or medications shortly before joining the study.
  • Must agree to use effective birth control during and after the study.
  • Must be willing to sign a consent form and follow study procedures.

Exclusion Criteria

  • Certain types of lymphoma that are not eligible, such as those involving the central nervous system or certain viral-related lymphomas.
  • History of certain brain or nervous system conditions, like seizures or strokes.
  • Recent history of certain cancers or heart conditions.
  • Uncontrolled high blood pressure or infections.
  • Certain autoimmune disorders or other immune system issues.
  • Use of certain medications or treatments that affect the immune system.
  • Previous treatment with CAR-T therapy targeting CD19.
  • Certain mental health conditions that affect decision-making.
  • Previous organ transplants.

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