CAR-T Cell Therapy for Desensitization in Kidney Transplantation

Study 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.

Primary Outcome

Adverse events will be categorized and described according to CTCAE v5.0. Specific safety outcomes will include but are not limited to: 1. Cytokine release syndrome, as defined by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading 2. Neurotoxicity (ICANS), as defined by ASTCT consensus grading 3. Delayed hematopoetic recovery: proportion of subjects achieving ANC \>1,000/microL (≥600/microL for those with Duffy null associated phenotype) and Platelets \>75,000/m

Conditions Studied

Interventions

• DRUG Cyclophosphamide
• DRUG Fludarabine
• BIOLOGICAL CART-BCMA
• BIOLOGICAL huCART19

Study Locations (3)