Summary

Eligibility
for people ages 18-60 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Sandy Feng, MD, PhD

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 de novo 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 de Novo Living Donor Renal Transplantation

Keywords

Kidney Transplantation, TCD601

Eligibility

You can join if…

Open to people ages 18-60

  • 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 or second 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
  • Subjects with a history of cancer
  • Donor-specific Antibody

Locations

  • UCSF Connie Frank Transplant Center not yet accepting patients
    San Francisco California 94143 United States
  • University of Maryland not yet accepting patients
    Baltimore Maryland 21201 United States

Lead Scientist at UCSF

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
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