MedPath

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

Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

Phase 2
Not yet recruiting
Conditions
Kidney Transplant Rejection
Interventions
First Posted Date
2025-04-09
Last Posted Date
2025-04-09
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
100
Registration Number
NCT06918990
Locations
🇺🇸

Mayo Clinic Arizona, Phoenix, Arizona, United States

🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Northwestern University, Feinberg School of Medicine, Chicago, Illinois, United States

and more 5 locations

Belatacept in Heart Transplantation

Phase 2
Recruiting
Conditions
Heart Transplant
Interventions
First Posted Date
2024-06-27
Last Posted Date
2025-02-11
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
66
Registration Number
NCT06478017
Locations
🇺🇸

Cedars Sinai Heart Institute/ Cedars Sinai Medical (Site # 71146), Los Angeles, California, United States

🇺🇸

Tampa General Hospital (Site # 71150), Tampa, Florida, United States

🇺🇸

NYU Langone Health (Site # 71177), New York, New York, United States

and more 1 locations

Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination

Not yet recruiting
Conditions
HBV
Liver Transplantation
Kidney Transplantation
Interventions
First Posted Date
2024-03-13
Last Posted Date
2024-03-13
Lead Sponsor
University Hospital, Grenoble
Target Recruit Count
66
Registration Number
NCT06307808
Locations
🇫🇷

Grenoble University Hospital, Grenoble, Aura, France

Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>

Phase 4
Not yet recruiting
Conditions
Kidney Diseases
Interventions
Drug: anticalcineurins
First Posted Date
2024-03-04
Last Posted Date
2024-03-04
Lead Sponsor
University Hospital, Rouen
Target Recruit Count
44
Registration Number
NCT06291077

Advancing Transplantation Outcomes in Children

Phase 2
Recruiting
Conditions
Kidney Transplant
Interventions
First Posted Date
2023-09-28
Last Posted Date
2025-02-26
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
200
Registration Number
NCT06055608
Locations
🇺🇸

University of Alabama at Birmingham (Site # 71038), Birmingham, Alabama, United States

🇺🇸

Children's Hospital of Los Angeles (Site #: 71036), Los Angeles, California, United States

🇺🇸

Cedars-Sinai Medical Center (Site #: 71026), Los Angeles, California, United States

and more 18 locations

Evolution of CMV Antiviral T-cell Immunity Over the Next Six Months Initiation of Treatment With Belatacept.

Not yet recruiting
Conditions
Kidney Transplant Infection
First Posted Date
2023-02-01
Last Posted Date
2023-02-01
Lead Sponsor
University Hospital, Rouen
Target Recruit Count
28
Registration Number
NCT05708534

A Study of TCD601 in de Novo Renal Transplant Recipients

Phase 2
Active, not recruiting
Conditions
Renal Transplantation
Interventions
First Posted Date
2022-12-30
Last Posted Date
2025-04-17
Lead Sponsor
ITB-Med LLC
Target Recruit Count
90
Registration Number
NCT05669001
Locations
🇺🇸

Scripps Green Hospital, La Jolla, California, United States

🇺🇸

University of Southern California, Los Angeles, California, United States

🇺🇸

University of California Davis Medical Center, Sacramento, California, United States

and more 24 locations

Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction

Phase 3
Recruiting
Conditions
Chronic Kidney Failure
Interventions
First Posted Date
2022-10-03
Last Posted Date
2024-05-09
Lead Sponsor
Nantes University Hospital
Target Recruit Count
30
Registration Number
NCT05562869
Locations
🇫🇷

CHU Nantes, Nantes, Loire Atlantique, France

Novel Desensitization Kidney Transplantation

Phase 1
Recruiting
Conditions
Kidney Transplantation
End Stage Kidney Disease (ESRD)
Interventions
First Posted Date
2022-04-26
Last Posted Date
2024-06-04
Lead Sponsor
University of Chicago
Target Recruit Count
5
Registration Number
NCT05345717
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

Carfilzomib and Belatacept for Desensitization

Phase 1
Recruiting
Conditions
Highly Sensitized Prospective Kidney Transplant Recipients
Interventions
Procedure: Bone marrow aspiration
First Posted Date
2021-08-24
Last Posted Date
2025-02-20
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
15
Registration Number
NCT05017545
Locations
🇺🇸

Duke Transplant Center, Duke University Medical Center, Durham, North Carolina, United States

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