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

Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)

Phase 1

Completed

Conditions: Kidney Failure, Chronic
Renal Insufficiency

Interventions: Drug: Belatacept
Drug: ATG
Drug: Rituximab
Radiation: Total Body Irradiation
Radiation: Thymic Irradiation
Procedure: Combined Bone Marrow/Kidney Transplantation

First Posted Date: 2014-12-11

Last Posted Date: 2021-10-25

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 2

Registration Number: NCT02314403

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Phase 2

Recruiting

Conditions: Immunosuppression

Interventions: Drug: Belatacept
Procedure: Hand transplant

First Posted Date: 2014-12-08

Last Posted Date: 2025-04-02

Lead Sponsor: Linda Cendales

Target Recruit Count: 50

Registration Number: NCT02310867

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Belatacept 3 Month Post Transplant Conversion Study

Phase 4

Completed

Conditions: EBV
Transplant; Failure, Kidney

Interventions: Drug: belatacept
Drug: MPA
Drug: Tacrolimus

First Posted Date: 2014-08-11

Last Posted Date: 2023-02-08

Lead Sponsor: Lorenzo Gallon

Target Recruit Count: 28

Registration Number: NCT02213068

Locations: 🇺🇸
Northwestern University, The Comprehensive Transplant Center, Chicago, Illinois, United States

Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients

Phase 4

Completed

Conditions: Implant or Graft; Rejection

Interventions: Drug: Tacrolimus
Drug: Belatacept
Drug: Mycophenolate
Drug: rATG
Drug: Methylprednisolone
Procedure: Renal transplant

First Posted Date: 2014-06-02

Last Posted Date: 2021-02-10

Lead Sponsor: Columbia University

Target Recruit Count: 57

Registration Number: NCT02152345

Locations: 🇺🇸
Columbia University Medical Center, New York, New York, United States

Regimen Optimization Study

Phase 2

Completed

Conditions: Kidney Transplantation

Interventions: Drug: Thymoglobulin
Drug: mycophenolate mofetil(MMF)
Drug: Belatacept
Drug: Corticosteroids
Drug: Everolimus(EVL)
Drug: Tacrolimus(TAC)

First Posted Date: 2014-05-13

Last Posted Date: 2021-06-22

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 58

Registration Number: NCT02137239

Locations: 🇺🇸
Emory Univeristy, Atlanta, Georgia, United States
🇺🇸
University Of Illinois, Chicago, Illinois, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 17 locations