What is the mechanism of action of this treatment?

Common treatments for kidney transplantation primarily involve immunosuppressive agents that prevent the immune system from rejecting the transplanted organ. Siplizumab, an anti-CD2 antibody, works by targeting CD2 proteins on T cells, thereby inhibiting T cell activation and proliferation, which are crucial for initiating immune responses against the transplanted kidney. Other common agents include calcineurin inhibitors (e.g., cyclosporine, tacrolimus) that block T cell activation, and mTOR inhibitors (e.g., sirolimus) that inhibit T cell proliferation. These treatments are essential for kidney transplant patients as they help maintain the viability of the transplanted organ by preventing immune-mediated rejection, thereby improving long-term outcomes and graft survival.

What side effects are associated with this type of intervention?

Common treatments for kidney transplant, such as anti-interleukin-2 receptor monoclonal antibodies (basiliximab and daclizumab) and cyclosporine, are associated with several side effects. Basiliximab and daclizumab can cause adverse effects like infections, liver enzyme elevation, and gastrointestinal issues. Cyclosporine, while effective, has potential serious side effects including nephrotoxicity, hypertension, hyperlipidemia, and increased risk of infections. These side effects necessitate careful monitoring and management in patients undergoing kidney transplantation.

What prior FDA approvals exist?

FDA-approved treatments for kidney transplantation include immunosuppressive drugs such as basiliximab and daclizumab, which are anti-interleukin-2 receptor monoclonal antibodies. These drugs are used to prevent acute rejection in renal transplant recipients. Basiliximab and daclizumab are often combined with other immunosuppressive agents like cyclosporine, mycophenolate mofetil, and corticosteroids. While siplizumab, an anti-CD2 antibody, is being studied for its potential to induce tolerance in kidney transplant patients, it is not yet FDA-approved. The focus of these treatments is to modulate the immune response to prevent rejection of the transplanted kidney.

What other types of research exist?

Promising alternatives to Siplizumab for kidney transplant patients include anti-thymocyte globulin and basiliximab. Anti-thymocyte globulin has shown improved graft survival rates in liver transplantation and is preferred for high immunological risk renal transplant recipients. Basiliximab is another option, commonly used as an induction agent in lung transplantation.

← Back to Search

Monoclonal Antibodies

TCD601 for Kidney Transplant Rejection Prevention

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

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 a treatment that uses a special medicine, donor bone marrow cells, and mild pre-treatment to help patients receiving new kidney transplants from living donors accept their new organ.

Who is the study for?

This trial is for adults aged 18-60 who are receiving their first or second kidney transplant from a living donor who's at least a half-match. Participants must understand the study and agree to its terms. People with cancer, specific donor antibodies, or women able to have children cannot join.

What is being tested?

The PANORAMA study is testing TCD601 (siplizumab) combined with bone marrow cells from the donor and a special conditioning treatment in new kidney transplant patients to see if it helps them accept the organ without long-term immune suppression.

What are the potential side effects?

Potential side effects of siplizumab may include allergic reactions, increased risk of infections due to immune system suppression, possible infusion-related reactions, and other effects that could impact organ function.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 60 years old.

Select...

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:

Select...

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 optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment1 Intervention

TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Group II: 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 / 3Eligibility 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 agents that prevent the immune system from rejecting the transplanted organ. Siplizumab, an anti-CD2 antibody, works by targeting CD2 proteins on T cells, thereby inhibiting T cell activation and proliferation, which are crucial for initiating immune responses against the transplanted kidney. Other common agents include calcineurin inhibitors (e.g., cyclosporine, tacrolimus) that block T cell activation, and mTOR inhibitors (e.g., sirolimus) that inhibit T cell proliferation. These treatments are essential for kidney transplant patients as they help maintain the viability of the transplanted organ by preventing immune-mediated rejection, thereby improving long-term outcomes and graft survival.

The Humoral Immune Response Against the gB Vaccine: Lessons Learnt from Protection in Solid Organ Transplantation.Biomarkers of Tolerance in Kidney Transplantation: Are We Predicting Tolerance or Response to Immunosuppressive Treatment?Advances in pharmacotherapy to treat kidney transplant rejection.