Study on E7777 Before Kymriah for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor: Masonic Cancer Center, University of Minnesota

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04855253

Provider View

This clinical trial is testing the safety of a new drug, E7777, given before standard chemotherapy and Kymriah treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are at higher risk of not responding to CAR-T therapy.

Patient Parameters

Program Overview

This study aims to find the safest dose of E7777, a new drug, when given before chemotherapy and Kymriah, a CAR-T cell therapy, for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The trial is for patients who are at a higher risk of not responding to CAR-T therapy. E7777 is designed to target specific immune cells to help prepare the body for CAR-T treatment.

Description

E7777 is a new type of drug that combines a human protein with a toxin to target certain immune cells. This trial is testing if E7777 can help prepare the body for CAR-T cell therapy by targeting immune cells that express a marker called CD25. The standard treatment involves using CAR-T cells, which are a type of therapy that uses a patient's own modified immune cells to fight cancer. This study is looking at whether adding E7777 before the standard treatment can improve outcomes for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or refractory large B-cell lymphoma, planning to receive Kymriah treatment, including:
    • Diffuse large B-cell lymphoma (DLBCL)
    • High-grade B-cell lymphoma
    • DLBCL from follicular lymphoma
  • Considered high risk for progression after CAR-T therapy if:
    • Cancer did not respond to last treatment
    • High myc expression in any previous biopsy
    • Two or more sites of cancer outside the lymph nodes
  • Received two or more lines of systemic therapy
  • Has insurance coverage for Kymriah treatment
  • Age 18 or older
  • Good overall health with an ECOG performance status of 0, 1, or 2
  • Adequate bone marrow function:
    • Neutrophil count over 1,000/mm³
    • Platelet count 50,000/mm³ or higher (transfusions allowed)
    • Hemoglobin over 8.0 mg/dl (transfusions allowed)
  • Adequate organ function:
    • Kidney function: eGFR 50 mL/min/1.73 m² or higher
    • Liver function: ALT and AST within 3 times the normal limit, bilirubin within 2.0 mg/dl (exceptions for Gilbert syndrome)
    • Albumin 3.0 g/dl or higher
  • Good lung function and oxygen levels
  • Stable heart function with LVEF 50% or higher
  • Life expectancy of at least 12 weeks
  • Women and men must agree to use birth control during and after treatment
  • Willing to provide written consent

Exclusion Criteria

  • Pregnant or breastfeeding women
  • Known bone marrow involvement
  • Previous allogeneic transplant
  • Eye problems affecting vision
  • Known cancer spread to the brain or spinal fluid
  • Uncontrolled hepatitis B or C
  • Active or inactive HIV infection
  • Untreated active infections
  • History of heart failure or fluid buildup in the lungs
  • Recent heart attack or unstable chest pain
  • Use of investigational drugs within 7 days before treatment

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