This study is in progress, not accepting new patients

A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)

a study on Kidney Transplant

Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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

Official Title

An Adaptive, Regimen Finding, Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, for Tolerance Induction in Living Donor Renal Transplantation

Keywords

Kidney Transplantation, TCD601

Eligibility

You can join if…

Open to people ages 18-65

  • 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

You CAN'T join if...

  • 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)

Locations

  • UCSF Connie Frank Transplant Center
    San Francisco California 94143 United States
  • University of Maryland
    Baltimore Maryland 21201 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ITB-Med LLC
ID
NCT04803006
Phase
Phase 2 Kidney Transplant Research Study
Study Type
Interventional
Participants
Expecting 18 study participants
Last Updated