🏛️ Verified NIH Record • Updated 2026-05-19

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

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (19 items) and avoid the listed exclusions (32 items).

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 Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Subjects with indwelling catheters as primary access for hemodialysis
  • Previous solid organ (except kidney) or bone marrow transplant
  • BMI ≥35 kg/m\^2
  • Subjects who have preserved or oliguric urine output \> 100 cc/day with history of recurrent UTI (2 in 6 months or 3 in 1 year, see study definitions)
  • Subjects described in exclusion #4 with structural disease such as polycystic kidney disease, obstructive uropathy with nephrolithiasis or those otherwise at higher risk of urinary tract infections. Anuric subjects with structural kidney disease are not excluded
  • Known active current or history of invasive fungal infection; any non-tuberculous mycobacterial infection that has been active or has required therapy within the last year. Any infection requiring hospitalization and IV antibiotics within 4 weeks of screening or PO antibiotics within 2 weeks
  • History of HIV, chronic HBV, or chronic HCV, regardless of treatment
  • Negative CMV serology
  • Detectible viral load HBV, HCV, CMV, EBV, or BK by PCR
  • Any B cell depleting or monoclonal antibody therapy within 6 months prior to enrollment
  • Receiving ongoing immunosuppression including corticosteroids \>5mg/day, intravenous immunoglobulin, cyclophosphamide, tacrolimus, mycophenolic acid, or azathioprine from 30 days prior to study entry

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗