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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months after transplantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months after transplantation
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 • NCT0207819367%
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).
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have any medical issues that aren't mentioned in the criteria above, and they might interfere with your ability to participate in the study or affect the accuracy of the results, you may not be eligible.You are waiting to receive a new heart.I am not currently in a trial that involves treatment at the time of my transplant.I do not have any active infections, except for possible driveline infections.I might need dialysis after a transplant.I have been treated with belatacept or abatacept before.I have not undergone desensitization therapy before a transplant.I am in a trial for a device or drug that ends with my transplantation.I have had active tuberculosis in the past.You have had an organ transplant in the past.I have been treated with cytolytic therapy before.I am planned to receive cell-killing therapy after a transplant.I have or had HIV, Hepatitis B, or Hepatitis C.I have untreated latent TB.I have been screened for TB and treated if it was found.I have not received a live vaccine in the last 30 days.I was diagnosed with cancer within the last 5 years.I have been treated with alkylating agents or had total lymphoid irradiation.I am a heart transplant candidate with high immune response or undergoing desensitization treatment.I have taken medication for rheumatic disease in the last year.I might be treated with a specific transplant medication other than Prograf.I was not on a heart-lung machine for more than 72 hours after my transplant.I require strong medication to maintain my blood pressure more than 3 days after a transplant.I am between 18 and 75 years old and not pregnant.I can take pills and follow a schedule for receiving belatacept infusions.My vaccinations for hepatitis B, flu, pneumonia, haemophilus, chickenpox, MMR, and HPV (if I'm under 45) are current.I am a woman who can have children and have a negative pregnancy test.You are waiting for a transplant of multiple organs.I have had a brain or spinal cord infection before.I am currently on medication to suppress my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Belatacept
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.