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NCT04803058 Clinical Trial

A Study of TCD601 in the Induction of Tolerance in de Novo Renal Transplantation (PERSPECTIVE)

Kidney Transplantation Clinical Trial

Official title:
A Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, Including Fludarabine and Cyclophosphamide, for Tolerance Induction in de Novo Living Donor Renal Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04803058
Other study ID # TCD601A202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 14, 2022
Est. completion date December 2027

Study information
Verified date March 2024
Source ITB-Med LLC
Contact Shannon Zentmeyer, BSN
Phone 347-326-1985
Email shannon.zentmeyer@itb-med.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in de novo living donor renal transplant recipients

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date December 2027
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Key Inclusion Criteria: - Able to understand the study requirements and provide written informed consent before and study assessment is performed. - Male or female patients = 18 to 60 years of age. - Recipient of a first renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor. Key Exclusion Criteria: - Women of child-bearing potential - Subjects with a history of cancer - Donor-specific antibody

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• TCD601
Investigational Product

Locations
Country Name City State
Korea, Republic of Samsung Medical University Seoul
United States Massachusetts General Hospital Boston Massachusetts
United States University of Chicago Chicago Illinois
United States University of Texas Southwestern Medical Center Dallas Texas
United States Weill Cornell New York New York
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
ITB-Med LLC

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance The proportion of patients off immunosuppression with good safety and tolerability 24 months
Secondary Incidence of biopsy proven acute rejection, death, and graft loss 24 months
Secondary The incidence of de novo DSA 24 months
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