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CLINICAL TRIALS IN ORGAN TRANSPLANTATION CTOT-21: Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation

Primary Objective

Primary Safety Objective: This study will evaluate the safety of polyTregs in adult kidney transplant recipients. Secondary Safety Objective: Participants receiving polyTregs will be evaluated for the safety of converting from CNI‐based maintenance therapy to mTOR inhibitors after Treg therapy. Primary Efficacy Objective: This study will evaluate whether polyclonally expanded Tregs (polyTregs) reduce graft inflammation relative to their enrollment biopsy compared to those receiving CNI‐based maintenance therapy with similar baseline biopsy findings. Secondary Efficacy Objective: This study will evaluate whether polyTregs can reduce graft inflammation by 25% or more in the 2 weeks after polyTreg infusion relative to the enrollment biopsy.

Study category: Kidney Disease & Hypertension

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Description

This is an open label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with SCI in the 3 to 7 months pos-transplant allograft biopsy compared to control patients treated with CNI-based immunosuppression. The efficacy of the Treg therapy will be assessed by the reduction of graft inflammation on biopsies performed at 7 months after study group allocation compared to the eligibility biopsy.

Details
Age

Adult

Phase

I/II - A combination of phases: (1) Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants; and (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Alexander Wiseman,  MD

Alexander Wiseman, MD

Study ID

Protocol Number: 18-2679

More information available at ClinicalTrials.gov: NCT02711826

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