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NCT06056102 · ClinicalTrials.gov registry record · Phase 1
CAR-T Cell Therapy for Desensitization in Kidney Transplantation
A Phase 1 study of Kidney Transplant and Kidney Failure, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 3
- Study locations
NCT06056102 is a Phase 1 study of Kidney Transplant and Kidney Failure that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants, below the 1,898-participant average among 30 other Kidney Transplant trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06056102, a Phase 1 study of Kidney Transplant and Kidney Failure, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 3
- Study locations
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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL CART-BCMA
- BIOLOGICAL huCART19
Study Locations (3)
Massachusetts
- Massachusetts General Hospital: Transplantation (Site #: 71107) - Boston
New York
- NYU Langone Health (Site #: 71177) - New York
Pennsylvania
- University of Pennsylvania Medical Center (Site #: 71111) - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-05-09 |
| Est. Completion | 2042-12-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06056102
The ClinicalTrials.gov registry entry for NCT06056102 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,898-participant average among 30 other Kidney Transplant trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Kidney Transplant appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT06056102 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Massachusetts, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06056102 about?
NCT06056102 is a clinical study titled "CAR-T Cell Therapy for Desensitization in Kidney Transplantation". 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 produc...
What is the current status of trial NCT06056102?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-05-09. Estimated completion is 2042-12-15.
What conditions does trial NCT06056102 study?
This clinical trial studies the following conditions: Kidney Transplant, Kidney Failure, End Stage Renal Failure on Dialysis.
What interventions are being tested in trial NCT06056102?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), CART-BCMA (BIOLOGICAL), huCART19 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06056102?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06056102 being conducted?
This trial has 3 study locations across Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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