NCT02088931|CompletedPhase 1DMC
Treg Adoptive Therapy for Subclinical Inflammation in Kidney Transplantation
TASK
A Pilot Trial of CD4+CD127lo/-CD25+ Polyclonal Treg Adoptive Immunotherapy in Renal Transplant Recipients
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Sponsor study identifier
interventional
3
1 country
1
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 31, 2016
Actual (reported)Study Completion
December 31, 2016
Actual (reported)The purpose of this study is to test the safety of the experimental therapy of a single infusion of Regulatory T cells (Tregs). The investigators want to find out what effects, good or bad, Tregs will have on the kidney transplant patients. There are different types of T cells. This study uses Regulatory T cells (Tregs), which are found in the blood and are part of the immune system that stops other immune cells from working. Tregs help to turn off the immune system after other immune cells have finished tackling outside infections, and Tregs keep the immune system in check so that the body does not attack itself. The researchers are hoping that, by giving an infusion of Tregs that the attack on the kidney can be stopped and kidney function will be stabilized. It is not known if the Treg experimental therapy can stop the inflammation in the kidney. In this study, the researchers will take some of Tregs from the patient, multiply them in the laboratory, and then infuse them back into the patient. The procedure used to multiply Tregs is an experimental process performed in the laboratory. Similar procedures done with mice have been shown to reverse inflammation but it is not known whether the results will be the same in humans. This therapy has not yet been done in humans outside of a research study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2016
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 13, 2014
Actual (reported)March 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 17, 2014
Actual (reported)December 31, 2016
Actual (reported)December 31, 2016
Actual (reported)Number of Patients with Adverse Events.
Participants will be assessed for adverse events on days 0-1 (Treg infusion) and on days 4,7,14,21,28,84,180, and 360 (1 year).
1 year
Patient Survival
Patient survival at 1 year and 3 years post renal transplantation.
3 years
Renal Allograft Survival
Renal allograft survival at 1 year and 3 years post renal transplantation.
3 years
Renal Allograft Dysfunction
Incidence of renal allograft dysfunction during the 1 year follow-up period post Treg infusion.
1 year
Presence of Intragraft Tregs in the Renal Allograft Biopsy
2 weeks
Change in circulating Treg Cells
2 weeks
Change from Baseline in Urinary Protein
1 year
3 subjects with inflammation on their 6-month surveillance biopsy following renal transplantation will receive a single infusion of a target of 320 million ex vivo selected and expanded autologous polyclonal Tregs. After the therapy visit the patient will return for a total of nine (9) more visits for the main part of the study: 1 and 4 days after therapy, then once a week for 4 weeks, and then 3, 6, and 12 months after you get the therapy.
At the time of Treg infusion (day 0), maintenance immunosuppression will remain unchanged which consists of TAC, MPA and steroids. On follow-up biopsy 2 weeks after Treg infusion, the inflammatory load will be assessed by computer assisted image analysis looking at the number of infiltrating cells per square mm as well as the percentage of renal cortex infiltrated with lymphocytes. If the inflammatory load has decreased by ≥50% and infused Tregs are observed in the allograft, everolimus will be started at 1.5 mg bid and the dose of tacrolimus will be decreased by 50%. After 2 weeks, tacrolimus will be discontinued. These patients will remain on everolimus, mycophenolic acid and prednisone through the end of the study and the follow-up period. If on the 2-week follow-up biopsy, there is no decrease in the inflammatory load or there is a decrease \<50%, no change will be made to the maintenance immunosuppressive regimen consisting of TAC, MPA and prednisone.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of California, San Francisco
San Francisco, California, 94143, United States
Nankivell BJ, Borrows RJ, Fung CL, O'Connell PJ, Allen RD, Chapman JR. Natural history, risk factors, and impact of subclinical rejection in kidney transplantation. Transplantation. 2004 Jul 27;78(2):242-9. doi: 10.1097/01.tp.0000128167.60172.cc.
Kee TY, Chapman JR, O'Connell PJ, Fung CL, Allen RD, Kable K, Vitalone MJ, Nankivell BJ. Treatment of subclinical rejection diagnosed by protocol biopsy of kidney transplants. Transplantation. 2006 Jul 15;82(1):36-42. doi: 10.1097/01.tp.0000225783.86950.c2.
Flavio Vincenti, MD
University of California, San Francisco
3 participants (actual enrollment reported by the registry).
First Submitted
January 13, 2014
First Posted
March 17, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Sakaguchi S, Yamaguchi T, Nomura T, Ono M. Regulatory T cells and immune tolerance. Cell. 2008 May 30;133(5):775-87. doi: 10.1016/j.cell.2008.05.009.
Tang Q, Bluestone JA, Kang SM. CD4(+)Foxp3(+) regulatory T cell therapy in transplantation. J Mol Cell Biol. 2012 Feb;4(1):11-21. doi: 10.1093/jmcb/mjr047. Epub 2011 Dec 14.
Primary Completion
December 31, 2016
Actual (reported)Study Completion
December 31, 2016
Actual (reported)Last Updated
July 13, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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