Not recruiting

Study of Glofitamab and Obinutuzumab for Patients with Relapsed or Refractory Lymphomas After CAR T-cell Therapy

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Relapsed/Refractory Lymphomas, which includes a condition known as Diffuse Large B-Cell Lymphoma (DLBCL). These are types of blood cancers that can return or do not respond to initial treatments. The study is evaluating a new treatment using a medication called Glofitamab, which is a special type of antibody designed to target and attack cancer cells. This medication is given as an infusion, meaning it is administered directly into the bloodstream through a vein. Another medication, Obinutuzumab, is also used in the study to help prepare the body for the main treatment.

The purpose of the study is to assess how well Glofitamab works in treating these lymphomas after patients have already received a type of therapy known as CAR T-cell therapy. This therapy involves modifying a patient's own immune cells to better fight cancer. The study will involve a series of treatments over a period of time, with regular monitoring to see how the cancer responds to the medication. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Participants in the study will receive the treatment through infusions and will be closely monitored by healthcare professionals. The study aims to understand the effectiveness of Glofitamab in improving survival rates and managing the disease. It will also look at how well patients tolerate the treatment and any changes in their quality of life. The study is designed to provide valuable information that could lead to better treatment options for people with these challenging types of lymphoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, current health status, and previous treatments.
A PET-CT scan is performed to confirm the presence of lymphoma cells expressing CD20, which is necessary for participation in the trial.
Step 2
Pre-treatment with obinutuzumab
The first medication administered is obinutuzumab, given as an intravenous infusion. This is a preparation step before starting the main treatment with glofitamab.
A SARS-CoV-2 PCR test is required within 48 hours prior to the administration of obinutuzumab.
Step 3
Glofitamab treatment
The main treatment involves glofitamab, a bispecific antibody targeting CD3 and CD20. This is administered intravenously.
The treatment is given in cycles, with the frequency and duration determined by the study protocol. Hospitalization is required for the administration of the first dose.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes blood tests, imaging studies, and clinical evaluations.
Patients are required to perform a SARS-CoV-2 PCR test at the start of each cycle of glofitamab.
Step 5
End of treatment evaluation
At the end of the treatment period, a comprehensive evaluation is performed to determine the overall response to the therapy.
This includes assessing the overall survival, metabolic response rate, and progression-free survival.

Who can join the trial?

22 criteria

Patients must have received CAR T-cells therapy for certain types of lymphoma at least 1 month ago.
Patients should not show a significant improvement in their condition after 1 month of CAR T-cells therapy.
The condition must be confirmed by a special scan called PET-CT.
For certain patients, the lymphoma cells must show a specific marker called CD20 after treatment.
Patients must be 18 years or older.
Patients should be in good general health, able to carry out daily activities without significant limitations.
The disease must be measurable by scans, with at least one tumor or lymph node larger than 1.5 cm.
No ongoing severe nerve-related side effects from previous CAR T-cells therapy.
Side effects from previous cancer treatments should have improved to a mild level.
Liver function should be within acceptable limits, with specific blood test results.
Blood cell counts should be at a certain level, unless affected by the disease itself.
Kidney function should be adequate, based on a specific calculation.
Women who can have children must have a negative pregnancy test before starting the study.
Tests for certain infections like hepatitis B, hepatitis C, and HIV must be negative.
Patients must agree to use effective birth control methods during and after the study for a specified time.
Patients must agree to stay in the hospital for the first dose of the study drug and follow all study procedures.
Patients must sign a consent form agreeing to participate in the study.
Patients should have a life expectancy of at least 3 months.
Patients must be covered by a social security system.
Patients must understand and speak one of the official languages of the country.
Patients should be up to date with vaccinations according to national guidelines.
Patients must agree to take a COVID-19 test before certain treatments in the study.

Who cannot join the trial?

3 criteria

Patients who have not experienced a return or worsening of their lymphoma after previous treatments cannot participate.
Patients who have not received anti-CD19 CAR T-cells therapy cannot participate. This therapy involves using special cells to target and destroy cancer cells.
Patients who are part of a vulnerable population, which means they might need extra protection or care, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
CHU Gabriel-Montpied
Verified
Clermont Ferrand, France
CHU Grenoble Alpes
Verified
La Tronche, France

Trial locations

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Investigated drugs

Glofitamab is a type of medication known as a bispecific monoclonal antibody. It is designed to target two specific proteins, CD3 and CD20, which are found on certain immune cells and lymphoma cells. In this trial, glofitamab is being tested for its ability to treat patients with a type of lymphoma called diffuse large B-cell lymphoma (DLBCL) that has returned or not responded to previous treatments, including CAR T-cell therapy. The goal is to see if glofitamab can help control or reduce the lymphoma in these patients.

What is already known about the treatment

Glofitamab – Glofitamab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapse or refractory lymphomas, particularly after CAR T-cell therapy. It is a bispecific monoclonal antibody that targets both CD3 and CD20 proteins, which are found on the surface of certain immune and cancer cells. By binding to these proteins, glofitamab helps the immune system recognize and destroy cancer cells. It is classified as an immunotherapy agent, specifically a bispecific antibody, and is being evaluated for its potential to improve outcomes in patients with difficult-to-treat lymphomas.

Investigated diseases

Relapsed/Refractory Lymphomas – This condition refers to lymphomas that have returned or are not responding to treatment after initial therapy. Lymphomas are cancers of the lymphatic system, which is part of the body's immune system. In relapsed cases, the disease reappears after a period of remission, while refractory lymphomas do not respond to standard treatments. The progression of these lymphomas can vary, with some cases advancing slowly and others more rapidly. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The disease can affect various parts of the body, including lymph nodes, spleen, and other organs.