Study on the Safety and Effects of IPH6501 for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Non-Hodgkin Lymphoma, specifically in patients whose disease has returned or not responded to previous treatments. The trial will investigate a new treatment called IPH6501, which is given as a solution through an infusion into the vein. The main goal of the study is to understand how safe and tolerable this new treatment is for patients, and to see if it has any effect on the cancer.

The study will be conducted in two phases. In the first phase, different doses of IPH6501 will be tested to find the safest and most effective dose. In the second phase, the treatment will be given to more patients to further evaluate its safety and potential benefits. Throughout the study, researchers will closely monitor patients for any side effects and how their cancer responds to the treatment.

Participants in this study will have a type of Non-Hodgkin Lymphoma that expresses a protein called CD20. This includes several subtypes of the disease, such as Diffuse Large B-Cell Lymphoma and Follicular Lymphoma. The study aims to provide valuable information about the new treatment, which could help in developing better therapies for this challenging condition in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and previous treatments for non-Hodgkin lymphoma.

Eligibility criteria include having relapsed or refractory CD20-expressing non-Hodgkin lymphoma, having received at least two prior systemic therapies, and having a measurable disease.

2 treatment phase 1

The first phase involves dose finding to determine the maximum tolerated dose of IPH6501. This is administered as an intravenous (IV) infusion.

The frequency and duration of the infusion are determined based on the safety and tolerability observed during this phase.

3 treatment phase 2

In the second phase, the recommended dose from phase 1 is used to further evaluate the treatment’s effects.

This phase focuses on expanding the dose to a larger group of participants to assess the preliminary antineoplastic activity of IPH6501.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess safety, tolerability, and any side effects.

Follow-up visits are scheduled to evaluate the treatment’s impact on the disease and to perform necessary tests.

5 end of trial

The trial is estimated to conclude by February 27, 2027.

Final assessments are conducted to gather data on the efficacy and safety of IPH6501.

Who Can Join the Study?

Patients must have a type of cancer called Non-Hodgkin’s Lymphoma (NHL) that has come back or is not responding to treatment. This includes specific types like Diffuse Large B Cell Lymphoma, High-grade B-cell lymphoma, Primary mediastinal large B-cell lymphoma, Follicular Lymphoma, Mantle cell lymphoma, and Marginal zone lymphoma.
Patients must have tried at least two different treatments before, including a treatment with an anti-CD20 antibody like rituximab, possibly combined with chemotherapy, or have relapsed after a procedure called autologous stem cell rescue.
Patients must be at least 18 years old.
Patients must have a tumor that can be measured. This means having at least one lymph node that is more than 1.5 cm in its longest dimension or a tumor outside the lymph nodes that is more than 1.0 cm in its longest dimension.
Patients must be able to perform daily activities with some limitations, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) performance status, which should be 2 or less.
Patients must be expected to live for at least 12 more weeks.
Any side effects from previous treatments must be stable and have improved to a mild level, except for non-serious side effects like hair loss.

Who Cannot Join the Study?

Patients who have a different type of cancer that is not CD20-expressing Non-Hodgkin Lymphoma.
Patients who are not experiencing a return of their cancer (relapsed) or whose cancer is not resistant to treatment (refractory).
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or do not agree to participate.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had certain treatments recently that might affect the study results.
Patients who have allergies or reactions to the study medication or similar drugs.
Patients who have a history of certain heart, liver, or kidney problems.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Lyon Sud	Pierre Benite	France
Institut Des Neurosciences De La Timone	Marseille	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Ifjtcbmu Pygozcsuegisxzc Cplyqy Cqzvnx	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	20.04.2024

Trial locations

Investigated drugs:

Iph6501

IPH6501 is an investigational medication being studied for its potential to treat patients with a type of cancer called Non-Hodgkin Lymphoma, specifically when the cancer has returned or has not responded to previous treatments. This medication is designed to target and act against cancer cells that express a protein known as CD20. The trial aims to understand how safe and tolerable IPH6501 is for patients, as well as to determine the most effective dose to use in future studies.

Investigated diseases:

Non-Hodgkin's lymphoma refractory

Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma – This is a type of cancer that affects the lymphatic system, specifically involving B-cells that express the CD20 protein. It is characterized by the return or persistence of the disease after initial treatment. The lymphoma cells grow uncontrollably, forming tumors in the lymph nodes and potentially spreading to other parts of the body. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The disease can vary in its rate of progression, with some forms being more aggressive than others. It requires ongoing monitoring to assess changes in the disease’s behavior.

Trial ID:

2023-506976-28-00

Protocol code:

IPH6501-101

NCT ID:

NCT06088654

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of IPH6501 for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?