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Regulatory T Cell Therapy

Regulatory T Cell Therapy for Kidney Transplants (RETIRE Trial)

Phase 2

Waitlist Available

Research Sponsored by Tract Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior organ transplant

Males or females aged 18-65 years undergoing a single organ, living donor kidney transplant

Must not have

Known sensitivity or contraindication to specified medications

Active infection not resolved prior to transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to month 60 post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of giving a type of immune cells called regulatory T cells (TRK-001) to prevent rejection of a transplanted kidney from a living donor. Patients

Who is the study for?

This trial is for living donor kidney transplant recipients. Participants must be eligible for a transplant and willing to follow the study procedures. Those with certain medical conditions, previous organ transplants, or who are unable to reduce immunosuppression drugs may not qualify.

What is being tested?

The trial tests if TRK-001 regulatory T cells can prevent organ rejection post-transplant. Patients will either receive standard care or standard care plus TRK-001, with some potentially reducing their medication after three months.

What are the potential side effects?

Possible side effects include those associated with immune system suppression such as increased infection risk and complications related to the infusion of TRK-001 which could involve reactions at the infusion site or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had an organ transplant.

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I am between 18 and 65 years old and getting a kidney transplant from a living donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic or react badly to certain medications.

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I currently have an infection that hasn't cleared up before a transplant.

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My BMI is either below 16 or above 38.

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I have a serious heart condition.

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I have had cancer, excluding certain skin cancers, in the last 3 years.

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I have a new health issue that affects my treatment with TRK-001.

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I am on long-term medication to suppress my immune system.

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I currently have an infection that hasn't cleared up yet.

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I am on long-term blood thinners.

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I currently have an infection that hasn't cleared up yet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to month 60 post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to month 60 post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and to month 60 post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful taper to monotherapy (Arm 2)

Secondary study objectives

Biopsy-proven acute rejection

Biopsy-proven subclinical rejection

Death (all cause)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2B: TRACT/MONO CNIExperimental Treatment1 Intervention

Arm 2: TRACT/MONO- At the beginning of the trial, subjects randomized to Arm 2 will be maintained on the prescribed 2-drug SOC immunosuppression and have a single infusion of expanded Tregs (TRK-001) at Day +53 to +67 following living donor kidney transplantation. At Month 3 post-transplant, Arm 2 TRACT/MONO subjects will be further randomized to either Arm 2A: TRACT/MONO mTOR or Arm 2B: TRACT/MONO CNI. Subjects randomized to Arm 2B: TRACT/MONO CNI who have a normal biopsy and no de novo donor specific antibodies at Month 3 will begin weaning of the mTOR medication and will remain on a 1-drug regimen with low dose tacrolimus until the end of the trial.

Group II: Arm 2A: TRACT/MONO mTORExperimental Treatment1 Intervention

Arm 2: TRACT/MONO- At the beginning of the trial, subjects randomized to Arm 2 will be maintained on the prescribed 2-drug SOC immunosuppression and have a single infusion of expanded Tregs (TRK-001) at Day +53 to +67 following living donor kidney transplantation. At Month 3 post-transplant, Arm 2 TRACT/MONO subjects will be further randomized to either Arm 2A: TRACT/MONO mTOR or Arm 2B: TRACT/MONO CNI. Subjects randomized to Arm 2A: TRACT/MONO mTOR who have a normal biopsy and no de novo donor specific antibodies at Month 3 will begin weaning of tacrolimus and will remain on a 1-drug regimen with either everolimus or sirolimus until the end of the trial.

Group III: Arm 1: Standard of Care (SOC)Active Control1 Intervention

Arm 1: SOC-Subjects randomized to Arm 1 will be followed on the prescribed 2-drug SOC immunosuppression throughout the trial. The study allowed SOC regimen is tacrolimus + sirolimus or everolimus.

0 / 12Eligibility criteria met