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Long-Term Follow-Up Study of TX200-TR101 for Patients with Kidney Transplant Rejection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term effects of a treatment called TX200-TR101, which is a type of cell therapy known as CAR-Treg therapy. This treatment is being investigated for its potential to help patients who have undergone a kidney transplant and are at risk of experiencing kidney transplant rejection. The therapy involves using a solution that is infused into the body through a vein, a process known as intravenous use.

The purpose of this study is to monitor the safety and tolerability of the TX200-TR101 infusion over a long period. This means researchers will be looking at how well patients tolerate the treatment and whether there are any serious side effects. The study will also track the overall health and survival of the participants, as well as any instances of the transplanted kidney being rejected or not functioning properly.

Participants in this study are individuals who have previously received a kidney transplant and participated in an earlier phase of the study. The study will continue to follow these patients to gather more information about the long-term effects of the treatment. This research aims to provide valuable insights into the potential benefits and risks of using TX200-TR101 for managing kidney transplant rejection.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing or withdrawing from the initial Phase I/IIa study TX200-KT02, where a kidney transplant was received.

    Written informed consent is required before any study-specific procedures or evaluations.

  2. Step 2

    Treatment administration

    The treatment involves the administration of TX200-TR101, a solution for infusion.

    The medication is given through an intravenous route, meaning it is delivered directly into the bloodstream.

  3. Step 3

    Monitoring and follow-up

    The main objective is to assess the safety and tolerability of the TX200-TR101 infusion.

    Monitoring includes checking for serious adverse events, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  4. Step 4

    Long-term evaluation

    The study aims to evaluate long-term safety and tolerability by observing overall survival and the incidence of serious adverse events.

    Secondary evaluations include monitoring for graft rejection, anti-drug antibodies, graft loss due to rejection, and chronic graft dysfunction.

  5. Step 5

    Study duration

    The estimated end date for the study is September 4, 2039.

    The recruitment for the study started on August 15, 2023.

Who can join the trial?

4 criteria

  • Participants must have been part of a previous study called Phase I/IIa study TX200-KT02, received a kidney transplant, and either completed or left that study.
  • Participants must be willing and able to sign a document called a written informed consent. This document shows that they understand the study and agree to take part. This must be done according to local rules and approved by an ethics committee or review board before any study-related procedures or evaluations are done.
  • Both men and women can participate in the study.
  • The study includes people who might be considered vulnerable, meaning they might need extra protection or care.

Who cannot join the trial?

4 criteria

  • Patients who have had a kidney transplant rejection cannot participate. This means their body has reacted against a transplanted kidney.
  • Patients who have experienced serious adverse events (SAEs) related to the study treatment cannot participate. SAEs are significant medical problems that can happen during a study.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age limits for who can join.
  • Patients who belong to a vulnerable population cannot participate. This refers to groups of people who might need special protection in a study.
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Investigated drugs

TX200-TR101 is a type of therapy known as CAR-Treg therapy. This therapy involves using a patient's own immune cells, which are modified to specifically target certain antigens. The goal of this therapy is to regulate the immune system in a way that can help manage or treat certain conditions. In this trial, the focus is on monitoring the long-term safety and tolerability of this therapy in patients who have previously received it.

What is already known about the treatment

TX200-TR101 – This medication is administered through infusion and is currently being studied in clinical trials for its safety and tolerability. It is primarily being investigated for its potential to treat kidney transplant rejection. The medication works by using a type of cell therapy known as CAR-Treg, which involves modifying the patient's own regulatory T cells to better control immune responses. TX200-TR101 falls under the pharmacological classification of cell-based therapies, specifically focusing on immune regulation.

Investigated diseases

Kidney Transplant Rejection – This condition occurs when the body's immune system identifies a transplanted kidney as foreign and attacks it. The immune response can lead to inflammation and damage to the kidney tissue. Over time, this can impair the kidney's ability to function properly. Symptoms may include decreased urine output, swelling, and high blood pressure. The progression of rejection can vary, with some cases being acute and others developing more slowly. Monitoring and managing the immune response is crucial to maintaining the health of the transplanted kidney.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512580-31-00Protocol codeTX200-KT03Estimated enrolment30 patientsSponsorSangamo Therapeutics Inc.

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