Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases

This research study is investigating a new treatment called tabelecleucel for various health problems caused by the Epstein-Barr virus (EBV). EBV is a common virus that can sometimes lead to serious conditions, especially in people with weakened immune systems or after organ transplants. These conditions can include certain types of lymphoma (a cancer of the immune system) or other abnormal cell growths. The study aims to find out if tabelecleucel is an effective treatment and whether it has any side effects. It’s a Phase 2 study, meaning it's still in the earlier stages of looking at how well the treatment works and its safety in a group of people, after initial safety checks. Participants will receive tabelecleucel weekly for three weeks in a repeating cycle.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Pierre Fabre Medicament

Enrolment target

190

Start

14 Jul 2021

Estimated completion

01 May 2028

Epstein-Barr Virus (EBV)-Associated Diseases EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD)EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD)Solid Organ Transplant Complications Lymphoproliferative Disorders Allogeneic Hematopoietic Cell Transplant Stem Cell Transplant Complications EBV+ Sarcomas Leiomyosarcoma

What is this study about?

This research study is focused on a new treatment called tabelecleucel for different diseases caused by the Epstein-Barr virus (EBV). EBV is a common virus that most people catch at some point, often causing no problems. However, in some individuals, particularly those whose immune system isn't working as it should – either from birth, due to other illnesses, or after transplants – EBV can lead to serious health issues. These can include certain types of cancer, like lymphomas (cancers of the white blood cells), or unusual growths of other cells.

The study aims to carefully check two main things about tabelecleucel: how well it treats these EBV-related conditions (its "efficacy") and whether it causes any unwanted side effects (its "safety"). The researchers want to see if this new treatment can help people who haven't responded well to usual treatments, or those for whom standard treatments aren't suitable. This is a "Phase 2" study, which means it builds on earlier research and focuses on gathering more information about the treatment's effectiveness and safety in a larger group of patients.

Participants in the study will have different EBV-related conditions, such as certain lymphomas that affect the brain, or specific types of soft tissue tumours called sarcomas, all linked to the EBV virus. The study is designed to be open-label, meaning both the patient and the doctors will know they are receiving tabelecleucel. By bringing together people with these different EBV-related conditions, the researchers hope to understand the full potential of tabelecleucel as a new treatment option.

Key takeaways

Targets diseases caused by the Epstein-Barr virus (EBV).
Investigating a new treatment called tabelecleucel.
Aims to check both effectiveness and safety.
For patients whose usual treatments haven't worked or aren't suitable.
Treatment given weekly for three weeks in 35-day cycles.

Who may be eligible?

To join this study, people must have an illness proven to be caused by the Epstein-Barr virus (EBV). This includes specific types of cancer or abnormal growths linked to EBV, especially if previous treatments haven't worked or aren't suitable.

Participants need to be well enough to take part, as measured by a scoring system that looks at how much daily activities are affected. Their organs, like kidneys and liver, should also be working well, unless their EBV-related illness is directly causing the problem. Those with certain EBV-related conditions affecting the brain must have had their diagnosis confirmed by tests.

However, some people won't be able to join. This includes individuals with certain other types of cancer or severe current infections. Also, those with a condition called graft-versus-host disease (GvHD) after a transplant, or needing a breathing machine, cannot take part. Having HIV or certain other specific medical conditions would also prevent someone from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have an illness diagnosed as being caused by the Epstein-Barr virus (EBV)?
Are you able to manage your daily activities reasonably well (e.g., Eastern Cooperative Oncology Group performance status ≤ 3 for adults)?
Are your major organs (like kidneys and liver) working adequately, or is any problem due to your EBV disease?
Do you NOT have an active infection that requires ongoing treatment?
Do you NOT have a severe ongoing condition called graft-versus-host disease (GvHD) if you've had a transplant?
Are you NOT currently on life support like a breathing machine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive the study treatment, tabelecleucel, which is given into your bloodstream through a drip (intravenously). Each treatment period, called a cycle, lasts for 35 days. During the first three weeks of each cycle, you'll have a dose of tabelecleucel once a week. After that, there will be a period of observation until the end of the 35 days. This cycle will repeat.

The treatment will continue for as long as it's helping you, or until your condition gets worse, you experience side effects that are too difficult to manage, or you need different treatment for your underlying illness. If you have a specific type of EBV-related sarcoma, your treatment might continue for up to 12 months, or until your condition improves significantly and stays stable. Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. If the initial treatment doesn't work well, doctors might consider giving you tabelecleucel again, but slightly modified, if available. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment, tabelecleucel, that might help your EBV-related condition, especially if standard treatments haven't worked or aren't an option. However, as with any new treatment, there are potential risks, including unknown side effects. While researchers carefully monitor participants, there's no guarantee the treatment will be effective, and it might not improve your condition. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (40)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of California Los Angeles (UCLA) (Adults and Pediatrics)
Verified postcode
Los Angeles, United States
Children's Hospital of Orange County (Pediatrics [up to 25 years old])
Verified postcode
Orange, United States
Lucile Packard Children's Hospital Stanford (Pediatrics only)
Verified postcode
Palo Alto, United States
University of California Davis Comprehensive Cancer Center (Adults and Pediatrics)
Verified postcode
Sacramento, United States
Sylvester Comprehensive Cancer Center/ University of Miami
Verified postcode
Miami, United States
Moffit Cancer Center (Adults only)
Verified postcode
Tampa, United States
Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old])
Verified postcode
Atlanta, United States
Emory University/Winship Cancer Institute (Adults [>= 16 years])
Verified postcode
Atlanta, United States
Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only)
Verified postcode
Chicago, United States
University of Maryland Medical Center (Adults only)
Verified postcode
Baltimore, United States
Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics)
Verified postcode
Boston, United States
University of Michigan Rogel Cancer Center (Adults and Pediatrics)
Verified postcode
Ann Arbor, United States

Common questions

What is the Epstein-Barr virus (EBV)?

EBV is a very common virus, but in some people, especially those with weakened immune systems, it can cause various serious illnesses, including certain cancers.

What is tabelecleucel?

Tabelecleucel is the new treatment being studied. It's designed to help the immune system fight diseases caused by the EBV virus.

What type of study is this?

This is a 'Phase 2' study, which means researchers are checking how well tabelecleucel works and if it's safe in a specific group of patients, after initial safety tests.

How will I receive the treatment?

The treatment will be given directly into your bloodstream through a drip, once a week for three weeks in a repeating 35-day cycle.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, and it will not affect your ongoing medical care.