Long-Term Safety Study of BCMACP03, BCN-CP01, and 19CP02 for Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, CLL, SLL, or Multiple Myeloma

3 1 1

What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment for certain types of blood cancers. The diseases being studied include Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), and Relapsed/Refractory Multiple Myeloma. The treatment involves a type of cell therapy known as CAR T-cell therapy, which uses the body’s own immune cells, called T cells, that are modified to better fight cancer. The specific treatments being tested are called BCMACP03, BCN-CP01, and 19CP02. These treatments are given as an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to evaluate the long-term safety of these CAR T-cell therapies for up to 15 years after the treatment is given. Participants in the study will be monitored over this period to check for any side effects or health changes. This includes looking at the type and frequency of any adverse events, which are unexpected medical problems that occur during treatment. The study will also track the presence of the CAR T-cells in the blood and any changes in the disease status, such as progression or the need for additional cancer treatments.

Throughout the study, researchers will collect information on overall survival and any new health issues that may arise. This information will help determine the long-term effects of the CAR T-cell therapies and their safety for patients who have received them. The study aims to provide valuable insights into how these treatments work over time and their impact on patients’ health.

1 joining the study

Upon joining the study, the patient must have previously received treatment with a GLPG CAR T-cell therapy in a clinical trial or Managed Access Program.

The patient must agree to follow the study protocol and sign an informed consent form.

2 initial assessment

An initial assessment is conducted to evaluate the patient’s current health status and medical history.

This assessment helps in understanding the patient’s baseline condition before the long-term follow-up begins.

3 treatment monitoring

The study involves monitoring the long-term safety of GLPG CAR T-cell products.

The patient will be observed for up to 15 years after the CAR T-cell product infusion.

4 regular check-ups

Regular check-ups are scheduled to monitor the patient’s health and any potential side effects.

These check-ups include blood tests to detect CAR transgene levels and replication-competent lentivirus.

5 adverse event reporting

Any adverse events, including serious ones related to the therapy, are documented.

The study aims to identify the type and frequency of these events.

6 disease progression monitoring

The patient’s disease progression status is regularly assessed.

This includes tracking the time to any subsequent anticancer therapy and overall survival.

7 end of study

The study is estimated to conclude by July 20, 2039.

At the end of the study, a final assessment will be conducted to evaluate the long-term effects of the treatment.

Who Can Join the Study?

The patient must be able and willing to follow the study’s rules and must sign a form agreeing to participate. This form is called an informed consent form, which is approved by a group that ensures the study is ethical.
The patient must have already received a treatment called GLPG CAR T-cell therapy in a previous clinical trial or through a special program that allows access to this treatment.
Both men and women can participate in the study.
The study includes people who might be considered vulnerable, meaning they may need extra care or protection.

Who Cannot Join the Study?

Patients who have not experienced a return or worsening of their B-Cell non-Hodgkin lymphoma.
Patients who have not experienced a return or worsening of their Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
Patients who have not experienced a return or worsening of their multiple myeloma.
Patients who are not within the specified age range for the study.
Patients who do not belong to the specified clinical trial group.
Patients who are not considered part of a vulnerable population.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Hospital Clinic De Barcelona	Barcelona	Spain
Cosrjeaex Uvbljzhixceqsz Sfkpislac	Woluwe-Saint-Lambert	Belgium
Lcqlz Upaqvyvpcxcn Mvrkrqu Cwfgfor (xzjyy	Leiden	The Netherlands
Hxpfbutd Umjcgndxhr Ciootss Hesqqdwp	Helsinki	Finland
Enhnlse Uvuugnphdhay Mbbyotk Coicyhv Rjtvkdzmi (guduqdm Mpd	Rotterdam	The Netherlands
Awnvuezip Uwt	Amsterdam	The Netherlands
Ukggvxhslq Oi Acqkabd	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	19.07.2024
Finland	Not yet recruiting	19.07.2024
Spain	Recruiting	19.07.2024
The Netherlands	Recruiting	19.07.2024

Trial locations

Investigated drugs:

GLPG CAR T-cell therapies are a type of treatment that uses specially modified cells from the patient’s own immune system to fight cancer. These cells, known as T-cells, are taken from the patient and genetically altered in a laboratory to better recognize and attack cancer cells. Once modified, the T-cells are infused back into the patient to help target and destroy cancer cells more effectively. This therapy is being studied for its long-term safety and effectiveness in treating certain types of cancer.

Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. The term “relapsed” refers to the return of the disease after treatment, while “refractory” indicates that the disease does not respond to treatment. It typically presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease can progress by spreading to other parts of the body, including the bone marrow and spleen. As it advances, it may lead to more severe symptoms and complications.

Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) – CLL and SLL are closely related types of cancer that affect the lymphocytes, a kind of white blood cell. In CLL, cancer cells are primarily found in the blood and bone marrow, while in SLL, they are mainly in the lymph nodes. “Relapsed” indicates the disease has returned after treatment, and “refractory” means it does not respond to treatment. Symptoms may include fatigue, swollen lymph nodes, and frequent infections. The disease can progress slowly, but over time, it may lead to more significant health issues.

Relapsed/Refractory Multiple Myeloma – This is a cancer of the plasma cells, which are a type of white blood cell found in the bone marrow. “Relapsed” means the cancer has returned after treatment, and “refractory” indicates it does not respond to treatment. It often causes bone pain, anemia, kidney problems, and high calcium levels in the blood. As the disease progresses, it can lead to bone fractures, severe infections, and other complications. The progression involves the accumulation of abnormal plasma cells in the bone marrow, affecting normal blood cell production.

Trial ID:

2023-510173-34-00

Protocol code:

LTF-CL-001

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Long-Term Safety Study of BCMACP03, BCN-CP01, and 19CP02 for Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, CLL, SLL, or Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?