CAR-T Cell Therapy for Desensitization in Kidney Transplantation
Status:
Recruiting
Trial end date:
2042-12-15
Target enrollment:
Participant gender:
Summary
This research study is for people who have been waiting for a kidney transplant for at least
one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that
your immune system would reject 99.5% of kidneys available for transplant. The study will
test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given
with chemotherapy, is safe and will reduce cPRA.
The main study will last up to 2 years: Participants will have up to 30 clinic or hospital
visits over a one-year period. If a transplant takes place, there will be 9 more visits after
transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15
years after receiving CAR T cell.
The primary objective is to evaluate the safety and feasibility of administering CART BCMA +
huCART-19 following lymphodepletion, including determination of optimal tolerated regimen
(OTR) and/or recommended phase 2 regimen, according to the incidence of dose limiting
toxicity (DLT) in highly sensitized patients awaiting kidney transplant.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
University of Pennsylvania Clinical Cell and Vaccine Production Facility (CVPF)