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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

Summary

This trial will test how well a new drug works in combination with bone marrow cells from a donor to help prevent organ rejection in people who have recently received a kidney transplant.

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.Check my eligibility
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.See study design
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
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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 have had cancer before.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome
Secondary outcome measures
The incidence of biopsy proven acute rejection, death and graft loss
The incidence of de novo donor-specific antibody

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3Experimental Treatment1 Intervention
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Group II: Arm 2Experimental Treatment1 Intervention
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Group III: 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

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.

Find a Location

Who is running the clinical trial?

ITB-Med LLCLead Sponsor
11 Previous Clinical Trials
369 Total Patients Enrolled
Nick Hryciw, MAStudy DirectorITB-MED
3 Previous Clinical Trials
65 Total Patients Enrolled

Media Library

TCD601 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04803006 — Phase 2
Kidney Transplant Research Study Groups: Arm 1, Arm 2, Arm 3
Kidney Transplant Clinical Trial 2023: TCD601 Highlights & Side Effects. Trial Name: NCT04803006 — Phase 2
TCD601 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04803006 — Phase 2
~11 spots leftby Jan 2027