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Terminated
NCT04803006
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)
Conditions: Kidney Transplantation
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 4
Sponsor: ITB-Med LLC
Location: Columbia University Irving Medical Center New York New York
Summary
The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation
Eligibility Criteria
Key Inclusion Criteria:
* Able to understand the study requirements and provide written informed consent before any study assessment is performed
* Male or female patients ≥ 18 to 65 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, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
* A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Recipient with anti-HLA donor-specific antibody (DSA)
Source: ClinicalTrials.gov (NCT04803006). StuddyBuddy aggregates publicly available trial information.
