Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UCSF
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 accepting new patients
    San Francisco California 94143 United States
  • University of Maryland accepting new patients
    Baltimore Maryland 21201 United States

Details

Status
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