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Tabelecleucel

Tabelecleucel, also known as ATA129, is an innovative cell therapy being studied in clinical trials for the treatment of various Epstein-Barr virus (EBV) associated diseases. This article explores the ongoing research on tabelecleucel, focusing on its potential benefits for patients with EBV-related conditions, particularly those who have not responded to standard treatments.

Table of Contents

What is Tabelecleucel?

Tabelecleucel, also known as ATA129 or Ebvallo, is an innovative cell therapy medication designed to treat various diseases associated with the Epstein-Barr virus (EBV)[1]. It is classified as an advanced therapy medicinal product, specifically a somatic cell therapy[1]. Tabelecleucel consists of allogeneic (donor-derived) EBV-specific cytotoxic T lymphocytes, which are a type of immune cell programmed to target and destroy EBV-infected cells in the body[1].

What Conditions Does Tabelecleucel Treat?

Tabelecleucel is being investigated for the treatment of several EBV-associated diseases, including:

  • Post-transplant lymphoproliferative disease (PTLD): A serious complication that can occur after organ or stem cell transplantation[1]
  • EBV-associated central nervous system PTLD (EBV+ CNS PTLD): PTLD affecting the brain and spinal cord[2]
  • EBV-associated primary immunodeficiency lymphoproliferative disease (EBV+ PID LPD): A condition occurring in individuals with inherited immune system defects[2]
  • EBV-associated lymphoproliferative disease in acquired immunodeficiency (EBV+ AID LPD): A condition occurring in individuals with weakened immune systems due to other factors[2]
  • EBV-associated sarcomas: Including leiomyosarcoma and other smooth muscle tumors[2]

How Does Tabelecleucel Work?

Tabelecleucel works by introducing EBV-specific cytotoxic T lymphocytes into the patient’s body. These specialized immune cells are designed to recognize and attack cells infected with the Epstein-Barr virus. By targeting EBV-infected cells, tabelecleucel helps to control the growth of EBV-associated tumors and reduce the symptoms of EBV-related diseases[1].

How is Tabelecleucel Administered?

Tabelecleucel is administered as an intravenous infusion. The treatment is typically given in cycles, with each cycle lasting 5 weeks (35 days). During a treatment cycle, patients receive tabelecleucel on days 1, 8, and 15. The maximum daily dose is 2 million organisms, with a maximum total dose of 36 million organisms over the course of treatment[1].

Current Clinical Trials

There are ongoing clinical trials evaluating the safety and efficacy of tabelecleucel:

  1. The ALLELE Study: A phase 3 trial for patients with EBV-associated PTLD after solid organ or allogeneic hematopoietic cell transplant who have failed prior treatments[1].
  2. The EBVision Study: A phase 2 trial investigating tabelecleucel in patients with various EBV-associated diseases, including those who are not eligible for standard treatments[2].

Efficacy of Tabelecleucel

The primary measure of tabelecleucel’s effectiveness in clinical trials is the objective response rate (ORR), which includes complete responses (CR) and partial responses (PR) to treatment. Secondary measures include:

  • Duration of response (DOR)
  • Overall survival (OS)
  • Progression-free survival (PFS)
  • Time to response
  • Graft status (for transplant patients)[1]

The results of these trials will provide important information about how well tabelecleucel works in treating various EBV-associated diseases.

Safety and Side Effects

As with any medical treatment, tabelecleucel may cause side effects. The ongoing clinical trials are carefully monitoring patients for any adverse reactions. Some potential concerns include:

  • Infections
  • Graft-versus-host disease (for transplant patients)
  • Immune system reactions

Patients receiving tabelecleucel are closely monitored during and after treatment to ensure their safety[1].

Patient Eligibility for Tabelecleucel Treatment

Eligibility for tabelecleucel treatment varies depending on the specific condition being treated. Generally, patients must have:

  • A confirmed diagnosis of an EBV-associated disease
  • Failed or been ineligible for standard treatments (in some cases)
  • Adequate organ function
  • No active, serious infections
  • No recent treatment with certain other therapies that could interfere with tabelecleucel[2]

Specific eligibility criteria may vary between different clinical trials and treatment protocols. Patients should consult with their healthcare providers to determine if tabelecleucel might be an appropriate treatment option for their condition.

Aspect Details
Drug Name Tabelecleucel (ATA129)
Type of Therapy Allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
Target Conditions EBV-associated post-transplant lymphoproliferative disease (PTLD), CNS PTLD, primary immunodeficiency LPD, acquired immunodeficiency LPD, EBV+ sarcomas
Administration Intravenous infusion on days 1, 8, and 15 of each 35-day cycle
Primary Endpoint Objective response rate (ORR)
Secondary Endpoints Overall survival, duration of response, progression-free survival
Key Inclusion Criteria EBV+ disease, failure of or ineligibility for standard therapies, measurable disease
Key Exclusion Criteria Active infections, need for vasopressor or ventilatory support, recent use of certain therapies
Trial Phase Phase 2 and Phase 3

FAQ

  • What is tabelecleucel? Tabelecleucel is a type of cell therapy made from allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs). It's designed to target and fight EBV-associated diseases in patients whose immune systems are compromised.
  • What conditions is tabelecleucel being studied for? Tabelecleucel is being investigated for several EBV-associated diseases, including post-transplant lymphoproliferative disease (PTLD), central nervous system PTLD, primary immunodeficiency lymphoproliferative disease, and EBV-positive sarcomas.
  • How is tabelecleucel administered? Tabelecleucel is given as an intravenous infusion. In the clinical trials, it's typically administered on days 1, 8, and 15 of each 35-day treatment cycle.
  • Who might benefit from tabelecleucel treatment? Patients who may benefit include those with EBV-associated diseases who have not responded to standard treatments like rituximab or chemotherapy, or for whom these treatments are inappropriate. This includes patients who have had organ or stem cell transplants.
  • What are the main goals of the tabelecleucel clinical trials? The primary goal is to determine the clinical benefit of tabelecleucel, measured by the objective response rate (ORR) in patients with various EBV-associated diseases. Secondary goals include evaluating overall survival, duration of response, and progression-free survival.

Ongoing Clinical Trials on Tabelecleucel

  • Study of Tabelecleucel for Patients with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Transplant Treatment Failure

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Italy Spain

  • Study on Tabelecleucel for Patients with Epstein-Barr Virus-Associated Diseases

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Italy Spain

Glossary

  • Tabelecleucel: A type of cell therapy made from allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs), designed to target EBV-associated diseases in immunocompromised patients.
  • Epstein-Barr Virus (EBV): A common virus that can cause infectious mononucleosis and is associated with certain types of cancer and lymphoproliferative disorders, especially in people with weakened immune systems.
  • Post-Transplant Lymphoproliferative Disease (PTLD): A condition that can occur after organ or stem cell transplantation, characterized by uncontrolled growth of lymphoid cells, often associated with EBV infection.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment, typically measured by imaging scans.
  • Rituximab: A type of targeted therapy (monoclonal antibody) commonly used to treat certain types of cancer and autoimmune diseases.
  • Allogeneic: Referring to cells or tissues that are taken from a different individual of the same species, as opposed to from the patient themselves.
  • Cytotoxic T Lymphocytes: A type of white blood cell that can kill cancer cells and cells infected with viruses.
  • Lymphoproliferative Disease: A condition in which lymphocytes (a type of white blood cell) are produced in excessive quantities, often associated with a weakened immune system.
  • Progression-Free Survival: The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Central Nervous System (CNS) PTLD: A form of post-transplant lymphoproliferative disease that affects the brain or spinal cord.

References

  1. http://clinicaltrials.eu/trial/study-of-tabelecleucel-for-patients-with-epstein-barr-virus-associated-post-transplant-lymphoproliferative-disease-after-transplant-treatment-failure/
  2. http://clinicaltrials.eu/trial/study-on-tabelecleucel-for-patients-with-epstein-barr-virus-associated-diseases/