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Study on Golcadomide for Patients with Relapsed or Refractory Aggressive Large B-Cell Lymphoma at High Risk of Relapse After CAR T-Cell Therapy

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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 aggressive large B-cell lymphoma, which is a form of non-Hodgkin lymphoma. This study is specifically for patients whose cancer has returned or has not responded to previous treatments and who are at high risk of the cancer coming back. The trial will explore the effectiveness of a medication called Golcadomide (also known by its code name BMS-986369) when given after a treatment known as CAR T-cell therapy. CAR T-cell therapy is a type of treatment where a patient's own immune cells are modified to better fight cancer cells.

The purpose of this study is to estimate how well Golcadomide works when administered after the CAR T-cell therapy. Participants in the study will receive the CAR T-cell therapy first, which involves an infusion of modified immune cells. After this, they will be given Golcadomide in capsule form. Some participants may receive a placebo instead of Golcadomide. The study will monitor the participants over a period to see how their cancer responds to the treatment and to assess any side effects.

The trial will last for several years, with the estimated end date being in 2027. During the study, researchers will look at various outcomes, such as the rate of complete response to the treatment, how long the response lasts, and overall survival rates. This information will help determine the potential benefits of using Golcadomide after CAR T-cell therapy in patients with aggressive large B-cell 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 reviewing medical history and current health status.
A biopsy may be required for centralized review to ensure the correct diagnosis of aggressive large B-cell lymphoma.
Step 2
CAR T-cell infusion
The first treatment involves the infusion of anti-CD19 CAR T-cells. This is a type of therapy where modified cells are introduced into the body to target cancer cells.
The infusion is administered as a dispersion for infusion, which means the treatment is given directly into the bloodstream.
Step 3
Post-infusion treatment with golcadomide
Following the CAR T-cell infusion, golcadomide is administered. This medication is taken orally in capsule form.
The dosage and frequency of golcadomide will be determined by the study protocol and the healthcare provider overseeing the treatment.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and other assessments to evaluate the effectiveness of the therapy.
The primary endpoint is the complete metabolic response rate at 3 months after the CAR T-cell infusion.
Step 5
End of study evaluation
At the conclusion of the study, a final evaluation is performed to determine the overall response to the treatment.
Secondary endpoints such as overall survival and progression-free survival are also assessed.

Who can join the trial?

14 criteria

The patient must have signed and understood an informed consent form before any study-related procedures.
The patient must have adequate liver function. This means certain liver enzymes (ALT/AST) should be at most 3 times the normal limit, unless the liver is affected by lymphoma, in which case they can be up to 5 times the normal limit. Total bilirubin, a substance made by the liver, should be at most 2.0 mg/dL, unless there are specific conditions like Gilbert's syndrome, where it can be up to 3.0 mg/dL.
The patient must be covered by a social security system in France.
The patient must understand and speak one of the official languages of the country, unless local rules allow for independent translators.
For women who can have children, they must agree to avoid pregnancy by either not having heterosexual intercourse or using two reliable birth control methods, starting from when they sign the consent form, during treatment, and for at least 28 days after the last dose of the study drug. They should also not donate eggs during this time.
For men, they must agree to avoid fathering a child by either not having heterosexual intercourse or using a condom with female partners who can have children or are pregnant, during treatment, and for at least 28 days after the last dose of the study drug. They should also not donate sperm during this time.
The patient must be an adult, at least 18 years old, with no upper age limit.
The patient must be eligible for any approved anti-CD19 CAR T-cell therapy.
The patient must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
The patient must have aggressive large B-cell lymphoma, which includes types like diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular or marginal zone lymphoma, and high-grade B-cell lymphoma. Patients with cancer in the central nervous system (CNS) can be included, but not those with primary CNS lymphoma.
The patient must have a biopsy available for review. If there are multiple biopsies, the most recent one should be used. If this biopsy has already been reviewed by a specific organization, that review can be used.
The patient must have an indication for CAR T-cell therapy as early as the second line of treatment and no later than the fourth line, as validated by a multidisciplinary tumor board and in line with marketing authorization.
The patient must have a tumor metabolic volume (TMTV) greater than 80 ml, measured by a centralized review, on a specific type of scan (18FDG-PET) done just before starting the CAR-T procedure.
The patient must have a creatinine clearance, which measures kidney function, greater than 45 mL/min. This is estimated by specific methods depending on the patient's age.

Who cannot join the trial?

6 criteria

Patients who have not experienced a return or worsening of their aggressive large B-cell lymphoma.
Patients who are not at high risk of their lymphoma coming back.
Patients who have not received a treatment called anti-CD19 CAR T-cell infusion.
Patients who are younger than 18 years old.
Patients who are older than 80 years old.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
CHU Grenoble Alpes
La Tronche, France
Verified
Centre Henri Becquerel
Rouen, France

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Investigated drugs

Golcadomide (BMS-986369) is a medication being studied for its effectiveness in patients with aggressive large B-cell lymphoma who are at high risk of relapse. It is given after a specific type of cell therapy called CAR T-cell infusion, which is designed to target and destroy cancer cells. The goal of using golcadomide in this trial is to see if it can help prevent the cancer from coming back after the initial treatment.

What is already known about the treatment

Golcadomide – Golcadomide is administered as an oral medication, typically taken in pill form. It is currently being studied in clinical trials for its effectiveness in treating patients with aggressive large B-cell lymphoma who are at high risk of relapse, particularly after receiving CAR T-cell therapy. The medication works by modulating the immune response, potentially enhancing the effects of previous treatments. It is classified as an immunomodulatory agent, which means it helps regulate the immune system to better fight cancer cells.

Investigated diseases

Aggressive Large B-Cell Lymphoma – This is a type of non-Hodgkin lymphoma characterized by the rapid growth of large B-cells, which are a type of white blood cell. It often presents with swollen lymph nodes, fever, night sweats, and weight loss. The disease can progress quickly, affecting various organs and tissues throughout the body. It is considered aggressive due to its fast progression and potential to spread beyond the lymphatic system. Relapsed or refractory cases occur when the disease returns after treatment or does not respond to initial therapies. These cases are at high risk of further relapse, requiring ongoing monitoring and management.