Belatacept

Generic Name: Belatacept

Brand Names: Nulojix

Drug Type: Biotech

CAS Number: 706808-37-9

Unique Ingredient Identifier: E3B2GI648A

Background: Belatacept is a soluble fusion protein, which links the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Structurally, abatacept is a glycosylated fusion protein with a MALDI-MS molecular weight of 92,300 Da and it is a homodimer of two homologous polypeptide chains of 357 amino acids each. It is produced through recombinant DNA technology in mammalian CHO cells. The drug has activity as a selective co-stimulation modulator with inhibitory activity on T lymphocytes. It is approved for the treatment of rheumatoid arthritis. Belatacept selectively blocks the process of T-cell activation. It was developed by Bristol-Myers-Squibb. Belatacept is only 2 amino acids different from abatacept (Orencia). FDA approved on June 15, 2011.

Indication: For prophylaxis of organ rejection. It is also used concomitantly with basiliximumab for induction therapy, mycophenolate, and corticosteriods in kidney transplant recepients that are seropositive for the Epstein-Barr virus.

Associated Conditions: Kidney Transplant Rejection

Clinical Trials

CNI Transient Replacement by Belatacept From 3 to 12 Months Post Transplantation in Patients With Early Graft Dysfunction

Phase 3

Conditions: Chronic Kidney Failure

Interventions: Drug: Belatacept 250 Milligram Intravenous Powder for Solution

First Posted Date: 2019-07-10

Last Posted Date: 2020-03-31

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 48

Registration Number: NCT04013620

Locations: 🇫🇷
CHU de Nantes, Nantes, France

Lung Transplant Plasmapheresis/Belatacept/Carfilzomib for Antibody Mediated Rejection and Desensitization

Phase 2

Withdrawn

Conditions: Lung Transplant Rejection
Antibody-mediated Rejection

Interventions: Drug: Belatacept
Drug: Carfilzomib

First Posted Date: 2019-01-15

Last Posted Date: 2019-05-02

Lead Sponsor: Duke University

Registration Number: NCT03805178

Tolerance by Engaging Antigen During Cellular Homeostasis

Phase 1

Active, not recruiting

Conditions: Renal Transplantation
Renal Transplant Recipient
Kidney Transplantation

Interventions: Biological: Donor-derived Mesenchymal Stromal Cells
Drug: alemtuzumab
Drug: belatacept
Drug: sirolimus
Drug: mycophenolate mofetil
Drug: mycophenolate acid
Drug: prednisone

First Posted Date: 2018-04-20

Last Posted Date: 2025-02-21

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 8

Registration Number: NCT03504241

Locations: 🇺🇸
Duke University Health System, Durham, North Carolina, United States

Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation

Phase 2

Completed

Conditions: Antibody-mediated Rejection
Lung Transplant Rejection

Interventions: Drug: Tacrolimus
Drug: Belatacept
Drug: ATG
Drug: Mycophenolate Mofetil
Drug: Methylprednisolone
Drug: Prednisone

First Posted Date: 2018-01-02

Last Posted Date: 2022-11-25

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 27

Registration Number: NCT03388008

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
Houston Methodist Hospital, Houston, Texas, United States