What side effects are associated with this type of intervention?

Common treatments for kidney transplant patients include immunosuppressive agents such as cyclosporine, tacrolimus, mycophenolate mofetil, and corticosteroids. These treatments are associated with various side effects. Cyclosporine and tacrolimus can cause nephrotoxicity, hypertension, and increased risk of infections. Mycophenolate mofetil is often linked to gastrointestinal issues like nausea and diarrhea, as well as bone marrow suppression. Corticosteroids can lead to weight gain, diabetes, osteoporosis, and increased susceptibility to infections. Prolonged use of these immunosuppressants generally increases the likelihood of adverse reactions.

What prior FDA approvals exist?

Several immunomodulatory agents have been approved by the FDA for the treatment of kidney transplant recipients to prevent rejection and induce tolerance. These include drugs like tacrolimus, cyclosporine, and sirolimus, which are commonly used in combination with mycophenolate mofetil and corticosteroids. Tacrolimus and cyclosporine are calcineurin inhibitors that suppress the immune response, while sirolimus is an mTOR inhibitor that also helps in reducing immune activity. Additionally, monoclonal antibodies such as basiliximab and alemtuzumab have been approved for induction therapy to prevent acute rejection. These treatments aim to achieve a balance between preventing rejection and minimizing adverse effects, similar to the goals of the TCD601 trial.

What other types of research exist?

Promising novel alternatives to TCD601 for kidney transplant patients include: 1) Fc-Silent Anti-CD154 Domain Antibody, which prevents renal allograft rejection without the risk of thromboembolism. 2) CD4 and CD8 monoclonal antibody therapy, which has shown immunosuppressive potential in large animal models. 3) Pharmacological inhibition of MyD88 signaling, which promotes robust allograft tolerance. 4) Costimulation blockade with agents like abatacept, which modulates T cell activation and has shown benefits in transplantation models.

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Monoclonal Antibodies

TCD601 for Kidney Transplant Tolerance (PERSPECTIVE Trial)

Phase 2

Recruiting

Research Sponsored by ITB-Med LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients ≥ 18 to 60 years of age.

Recipient of a first or second renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor.

Must not have

Women of child-bearing potential

Subjects with a history of cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing TCD601 to help new kidney transplant patients from living donors accept their new organ without immune system rejection.

Who is the study for?

This trial is for adults aged 18 to 60 who are receiving their first or second kidney transplant from a living donor who's at least half-matched genetically and has the same blood type. Participants must understand the study and agree to its terms. Pregnant women, those able to have children, or individuals with a history of cancer cannot join.

What is being tested?

The trial is testing TCD601 in patients getting new kidneys from living donors. It aims to see if this drug can help patients accept their new organ without the immune system attacking it (called 'tolerance').

What are the potential side effects?

While specific side effects of TCD601 aren't listed here, similar drugs may cause immune system suppression leading to increased infection risk, possible allergic reactions, and potential impact on liver and kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I have received a kidney transplant from a partially matched living donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman who could become pregnant.

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I have had cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TCD601

2021

Completed Phase 2

~20

0 / 4Eligibility criteria met

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 kidney transplantation primarily involve immunosuppressive and immunomodulatory agents that prevent the immune system from attacking the transplanted organ. These include calcineurin inhibitors (e.g., tacrolimus, cyclosporine), which inhibit T-cell activation; mTOR inhibitors (e.g., sirolimus, everolimus), which block cell proliferation; and monoclonal antibodies (e.g., rituximab, basiliximab), which target specific immune cells or receptors. The goal of these treatments is to induce a state of tolerance where the recipient's immune system accepts the transplanted kidney as its own, reducing the need for long-term immunosuppression and minimizing side effects. This is particularly relevant for agents like TCD601, which aim to achieve allogeneic tolerance, potentially improving long-term transplant outcomes and patient quality of life.

Immunobiology and immunopharmacology of organ allograft rejection.Reflections on the usefulness of extracorporeal photopheresis in renal transplant rejection: A concise review of the involved mechanisms and therapeutic perspectives.Clinical trials of transplant tolerance: slow but steady progress.