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Immunosuppressant

Belatacept for Heart Transplant

Phase 2
Recruiting
Led By Marlena V. Habal, MD
Research Sponsored by Marlena V. Habal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No desensitization therapy prior to transplant
Male or non-pregnant female, age ≥18 to ≤75 years
Must not have
The need or anticipated need for post-transplant dialysis
Prior treatment with belatacept or abatacept
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months after transplantation
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial is testing if Belatacept is safe for adult heart transplant patients. The medication helps prevent organ rejection by calming the immune system. It aims to improve long-term outcomes for these patients. Belatacept has shown promise in preserving kidney function in previous studies.

Who is the study for?
Adults aged 18-75 awaiting a primary heart transplant, who are EBV seropositive and can take oral meds. They must adhere to belatacept infusion schedule, have up-to-date vaccinations, and females of childbearing age need a negative pregnancy test. Excludes those with prior transplants, certain infections like HIV/HBV/HCV/TB, recent live vaccines, cancer in the last 5 years, high PRA levels or severe allergies to monoclonal antibodies.
What is being tested?
The trial is testing if Belatacept is safe for adult heart transplant recipients as an anti-rejection medication. It's being used investigatively alongside standard post-transplant drugs such as corticosteroids, tacrolimus and mycophenolate mofetil.
What are the potential side effects?
Belatacept may cause side effects including risk of infection due to immune suppression, possible allergic reactions related to infusions and interactions with other medications typically used after transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not undergone desensitization therapy before a transplant.
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I am between 18 and 75 years old and not pregnant.
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I can take pills and follow a schedule for receiving belatacept infusions.
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I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I might need dialysis after a transplant.
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I have been treated with belatacept or abatacept before.
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I have had active tuberculosis in the past.
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I have been treated with cytolytic therapy before.
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I am planned to receive cell-killing therapy after a transplant.
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I have or had HIV, Hepatitis B, or Hepatitis C.
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I have untreated latent TB.
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I was diagnosed with cancer within the last 5 years.
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I have been treated with alkylating agents or had total lymphoid irradiation.
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I am a heart transplant candidate with high immune response or undergoing desensitization treatment.
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I have taken medication for rheumatic disease in the last year.
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I was not on a heart-lung machine for more than 72 hours after my transplant.
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I require strong medication to maintain my blood pressure more than 3 days after a transplant.
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I have had a brain or spinal cord infection before.
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I am currently on medication to suppress my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months after transplantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months after transplantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Major Graft-Related Adverse Events

Side effects data

From 2016 Phase 4 trial • 3 Patients • NCT02078193
67%
COPD exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BelataceptExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belatacept
FDA approved
Corticosteroid
2005
Completed Phase 4
~2210
Tacrolimus
FDA approved
Mycophenolate mofetil
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for heart transplant patients, such as Belatacept, work by inhibiting T-cell activation, which is essential for preventing organ rejection. Belatacept specifically blocks the costimulatory signals required for T-cell activation, thereby reducing the immune system's ability to attack the transplanted heart. This mechanism is vital for heart transplant patients as it helps maintain the viability of the transplanted organ, reduces the risk of rejection, and improves long-term outcomes. Other immunosuppressive agents, like calcineurin inhibitors (e.g., tacrolimus) and antimetabolites (e.g., mycophenolate), also play a role by targeting different pathways in the immune response, ensuring comprehensive suppression of potential rejection mechanisms.
Belatacept in renal transplant recipient with mild immunologic risk factor: A pilot prospective study (BELACOR).

Find a Location

Who is running the clinical trial?

Marlena V. HabalLead Sponsor
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,070 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,695 Previous Clinical Trials
4,098,451 Total Patients Enrolled

Media Library

Belatacept (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04477629 — Phase 2
Heart Transplant Research Study Groups: Belatacept
Heart Transplant Clinical Trial 2023: Belatacept Highlights & Side Effects. Trial Name: NCT04477629 — Phase 2
Belatacept (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04477629 — Phase 2
~0 spots leftby Feb 2025