Belatacept in De Novo Heart Transplantation

NCT04477629 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 22-01135
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if Belatacept is safe to give to adult heart transplant recipients. Belatacept (NULOJIX) is an anti-rejection medication that is available through a prescription from a doctor. In this research study, belatacept is being used in an investigational manner (not for the purpose that it is approved for).

Conditions

Heart Transplantation

Keywords

Heart Transplant; Nulojix

Outcome Measures

Primary Outcomes (1)

• Number of Major Graft-Related Adverse Events

  Adverse events that will be counted in the total number include: Episodes of acute cellular rejection ≥ 2R/3A, antibody mediated rejection (AMR) ≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1, hemodynamically compromised rejection, development of cardiac allograft vasculopathy, graft failure occurring ≥ 14 days post-transplant, the need for re-transplant, serious infection requiring inpatient intravenous therapies, post-transplant lymphoproliferative disorder (PTLD), or death.

  Up to 18 months after transplantation

Secondary Outcomes (2)

• Change in Estimated Glomerular Filtration Rate (eGFR)

  Baseline and 18 months

• Percentage of Individuals with Development of De Novo Donor Specific Antibodies (DSA)

  18 months

Study Arms (1)

Belatacept

EXPERIMENTAL

Participants will receive Belatacept along with an upfront tacrolimus taper Participants will also receive mycophenolate mofetil and corticosteroids are part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice.

Drug: Belatacept; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Corticosteroid

Interventions

Belatacept DRUG

Belatacept will be given in the following way - 10mg/kg IV day 1, 5, end of weeks 2, 4, 8, 12 then 5mg/kg every 4 weeks.

Also known as: Nulojix

Belatacept

Tacrolimus DRUG

Non-experimental: Tacrolimus will be given in the following way - trough level at month 1, 10-12ng/mL; month 2-3, 6-10ng/mL; month 4-6, 4-6ng/mL; months 7-9 taper off.

Also known as: Tacrolimus taper

Belatacept

Mycophenolate Mofetil DRUG

Non-experimental: MMF is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at 500-1500mg twice a day (BID) (dosed to tolerance and effect).

Also known as: MMF

Belatacept

Corticosteroid DRUG

Non-experimental: CS is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at a dose no less than 5mg/d.

Also known as: CS

Belatacept

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female, age ≥18 to ≤75 years
• Awaiting a primary heart transplant (listed for heart transplant only)
• Epstein-Barr virus (EBV) IgG seropositive
• Able to take oral medication and willing to adhere to the belatacept infusion regimen
• No desensitization therapy prior to transplant
• Vaccinations should be up to date for hepatitis B, influenza pneumococcal, haemophilus, varicella zoster virus (VZV), measles, mumps and rubella (MMR), and Human Papilloma Virus (HPV) (for participants \< 45 years of age) when available
• Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization
• Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted
• Negative virtual crossmatch

You may not qualify if:

• Candidates awaiting multiorgan transplant
• Estimated glomerular filtration rate (eGFR) \< 45 ml/min/m2
• Candidates with prior organ transplant
• Candidates actively being treated with immunosuppressive therapies
• Candidates who have a history of treatment with cytolytic therapy (e.g. anti-thymocyte globulin)
• Candidates who are intended to be treated with cytolytic therapy in the post-transplant period as induction therapy
• EBV (IgG) seronegative
• Active or prior infection with human immunodeficiency virus (HIV), Hepatitis C (HCV), Hepatitis B (HBV)
• Untreated latent tuberculosis (TB)
• All potential candidates will be screened prior to enrolment for a history of tuberculosis (chest radiograph and tuberculosis-Interferon Gamma Release Assay (TB-IGRA) or tuberculin skin tests (TST)). Potential candidates with latent TB must be treated prior to study enrolment
• Prior history of active tuberculosis
• Prior history of central nervous system infection
• Known active current viral, fungal, mycobacterial, or other infections excluding driveline infections - potential participants from endemic areas will additionally be screened for histoplasmosis, blastomycosis, coccidioidomycosis, and strongyloidiasis
• Vaccination with a live vaccine within the past 30 days
• Malignancy within the last 5 years

Sponsors & Collaborators

• NYU Langone Health: lead
• Bristol-Myers Squibb: collaborator

Study Sites (2)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Abatacept; Tacrolimus; Mycophenolic Acid; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Marlena V. Habal, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Kim

CONTACT

646-457-0987; Andrea.Kim@nyulangone.org

Dylan McDonald

CONTACT

Dylan.Mcdonald@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study population includes first-time Epstein-Barr virus (EBV) seropositive, male and non-pregnant female heart transplant recipients 18 years of age or older, who are able to provide written informed consent for the study.

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 20, 2020
• Study Start: August 6, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (2)