NAV

Tabelecleucel

This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon.

Identification

Summary

Tabelecleucel is a medication that uses Epstein-Barr virus (EBV)-specific allogeneic cytotoxic T cells to treat EBV-associated post-transplant lymphoproliferative disorder.

Generic Name
Tabelecleucel
DrugBank Accession Number
DB17072
Background

Tabelecleucel is an innovative therapy that uses Epstein-Barr virus (EBV)-specific allogeneic cytotoxic T cells (CTLs). It is produced by mixing T-cells with B-cells that have been infected with the Epstein-Barr virus (EBV). Both T-cells and B-cells are obtained from the same donor, and T-cells are grown to increase their numbers. When given to a patient with EBV-associated post-transplant lymphoproliferative disorder (PTLD) following solid organ transplantation (SOT) or hematopoietic cell transplant, T-cells attack the patient's own infected B-cells, thereby helping to control this condition.1,2,3

In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended tabelecleucel be granted marketing authorization for the treatment of adult and pediatric patients who experience EBV-associated post-transplant lymphoproliferative disorder (PTLD) following solid organ transplantation (SOT) or bone marrow transplantation (hematopoietic cell transplant - HCT).3 The FDA has granted tabelecleucel Breakthrough Therapy Designation for EBV-associated PTLD following allogeneic HCT.4

Type
Biotech
Groups
Investigational
Biologic Classification
Cell transplant therapies
Autologous cell transplant
Synonyms
  • EBV-CTL
External IDs
  • ATA-129
  • ATA129
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Pharmacology

Indication

Not Available

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Pharmacodynamics

Not Available

Mechanism of action

Human B cells are the main targets of Epstein-Barr virus (EBV). In immunocompetent people, EBV usually has mild effects, but in immunocompromised patients, an EBV infection can lead to potentially life-threatening consequences. For instance, patients that have gone through solid organ or bone marrow transplantation may develop EBV-associated post-transplant lymphoproliferative disorder (PTLD), a type of cancer or lymphoma caused by an uncontrolled growth of cells in lymph nodes and other organs.2,4 Tabelecleucel consists of EBV-specific allogeneic cytotoxic T cells (CTLs) that specifically target EBV-infected B-cells, helping to control EBV-associated cancers.3,4

Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

Not Available

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

Categories

Drug Categories
Not Available
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
G3NJ7M8N4H
CAS number
Not Available

References

General References
  1. Chiou FK, Beath SV, Wilkie GM, Vickers MA, Morland B, Gupte GL: Cytotoxic T-lymphocyte therapy for post-transplant lymphoproliferative disorder after solid organ transplantation in children. Pediatr Transplant. 2018 Mar;22(2). doi: 10.1111/petr.13133. Epub 2018 Feb 1. [Article]
  2. Bollard CM, Savoldo B, Rooney CM, Heslop HE: Adoptive T-cell therapy for EBV-associated post-transplant lymphoproliferative disease. Acta Haematol. 2003;110(2-3):139-48. doi: 10.1159/000072463. [Article]
  3. EMA: First therapy to treat transplant patients with post-transplant lymphoproliferative disease [Link]
  4. Atara Biotherapeutics: Tabelecleucel (tab‐cel) – Investigational PTLD T-cell immunotherapy [Link]
Wikipedia
Tabelecleucel

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3CompletedTreatmentCoronavirus Disease 2019 (COVID‑19) / Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) / Lymphoproliferative Disorders / Stem Cell Transplant Complications1
3RecruitingTreatmentAllogeneic Hematopoietic Stem Cell Transplantation (HSCT) / Coronavirus Disease 2019 (COVID‑19) / Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) / Lymphoproliferative Disorders / Solid Organ Transplant Complications / Stem Cell Transplant Complications1
2CompletedTreatmentEBV-associated Malignancies / EBV-induced Lymphomas / Transplant Patients With EBV Viremia at High Risk for Developing a Recurrent EBV Lymphoma1
2CompletedTreatmentNasopharyngeal Carcinoma (NPC)1
2RecruitingTreatmentAllogeneic Hematopoietic Stem Cell Transplantation (HSCT) / EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD) / EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD) / EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD) / EBV+ Sarcomas / Epstein-Barr Virus (EBV)-Associated Diseases / Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) / Leiomyosarcoma (LMS) / Lymphoproliferative Disorders / Solid Organ Transplant Complications / Stem Cell Transplant Complications1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
Not Available
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created at October 18, 2022 23:36 / Updated at December 01, 2022 11:34