CAR-T Cell Therapy for Desensitization in Kidney Transplantation (NCT06056102)
Autologous Chimeric Antigen Receptor Engineered T Cell Immunotherapy for Desensitization in Patients Awaiting Kidney Transplantation
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Massachusetts General Hospital: Transplantation (Site #: 71107) — Boston, Massachusetts
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- Massachusetts General Hospital: Transplantation (Site #: 71107) — Boston, Massachusetts
- NYU Langone Health (Site #: 71177) — New York, New York
- University of Pennsylvania Medical Center (Site #: 71111) — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (215) 349-8334
Email: mary.kaminski@pennmedicine.upenn.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Dapagliflozin in Living-Donor Kidney Transplant Recipients — Guadalajara, Jalisco
- Phenotype Guided Vasoactive Medication During Kidney Transplantation — Los Angeles, California
- GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial — Livingston, New Jersey
- Letermovir for R+ Study — Madison, Wisconsin
Explore by condition: All Kidney Transplant clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.