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CAR-T Cell Therapy for Desensitization in Kidney Transplantation

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 4 entries Interventions modified · Eligibility criteria expanded, about 50 words · Study description revised · 2 more Show 5 more changesShow less
    • Interventions modified
    • Eligibility criteria expanded, about 50 words
    • Study description revised
    • Site contacts updated at 1 of 3 sites
    • Publications: details revised at 2 of 2 entries
  2. Eligibility criteria expanded, about 37 wordsv12 See this version in full on ClinicalTrials.gov ↗
  3. Site contacts updated at 1 of 3 sitesv11
  4. Site details revised at 2 of 3 sitesv10
  5. Primary endpoints revised (4) Eligibility criteria expanded, about 17 words · Site details revised at 1 of 3 sitesv9 Show 2 more changesShow less
    • Eligibility criteria expanded, about 17 words
    • Site details revised at 1 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

Show 7 earlier versionsHide 7 earlier versions
  1. Eligibility criteria expanded, about 5 wordsv8 See this version in full on ClinicalTrials.gov ↗
  2. Eligibility criteria expanded, about 11 wordsv7 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (3)v6 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 31, 2024 to May 9, 2024 · Study sites revised (3)v5 Show 2 more changesShow less
    • Start date changed from estimate of May 31, 2024 to May 9, 2024
    • Study sites revised (3)

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Mar 2024 to May 31, 2024v4
  6. Start date: Jan 5, 2024 to Mar 2024v3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06056102
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: University of Pennsylvania Clinical Cell and Vaccine Production Facility (CVPF)
Conditions Kidney Transplant, Kidney Failure, End Stage Renal Failure on Dialysis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov