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Stem Cell Transplantation

Kidney + Stem Cell Transplant for Kidney Transplant Rejection (OneLegacy Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Jeffrey Veale, MD

Eligibility Criteria Checklist

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

Must have

Males and females ages 18 years and older receiving living donor kidney transplant from an HLA-identical sibling at UCLA Medical Center

Meets institutional criteria for kidney and HSPC transplant

Must not have

Donor is identical twin

Multi-organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12, 24, 36, and 48 months post-kidney transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial is for kidney transplant recipients who receive a kidney from a sibling donor, testing an investigational treatment of a drug and radiation therapy followed by an infusion of blood stem cells from the same sibling. Researchers hope this will allow patients to stop immunosuppressive medications.

Who is the study for?

This trial is for adults over 18 who need a kidney transplant and can receive one from their sibling. They must be healthy enough for the procedure, with good heart and lung function, normal blood tests, and no severe infections or recent heavy drug use. Women of childbearing age must not be pregnant and agree to use contraception.

What is being tested?

The study is testing a new treatment that combines drugs (rATG), radiation therapy (TLI), and an infusion of donor stem cells after receiving a kidney from a sibling. The goal is to see if this approach helps patients accept the new organ without needing lifelong immunosuppressive drugs.

What are the potential side effects?

Potential side effects may include reactions to rATG like fever or chills, risks from radiation exposure such as fatigue or nausea, complications from stem cell infusion including infection risk increase, plus general surgery-related risks.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older and getting a kidney transplant from my sibling at UCLA.

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I meet the requirements for a kidney and stem cell transplant.

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I have no known allergies or adverse reactions to rATG or radiation.

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I am able to care for myself but may not be able to do active work.

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My lung function tests are at least half of what is expected.

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My liver tests are within the required range.

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My heart's pumping ability is at least 40%.

Exclusion Criteria

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

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My donor is my identical twin.

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I have received transplants for more than one organ.

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I am currently infected with the West Nile Virus.

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I do not have any uncontrolled illnesses like heart failure or need immunosuppression for autoimmune disease.

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I do not have any active infections, including hepatitis B or C.

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I have a positive HLA antibody test.

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I have been treated with rATG or am allergic to rabbit proteins.

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My blood type does not match the donor's.

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I have had a solid organ transplant.

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I have severe liver scarring due to hepatitis B or C.

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I have a kidney condition with a high chance of coming back.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12, 24, 36, and 48 months post-kidney transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12, 24, 36, and 48 months post-kidney transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, 36, and 48 months post-kidney 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

Withdrawal from immunosuppressive drugs

Secondary study objectives

Graft failure

Graft rejection

Survival

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Donor CD34+ and CD3+ cell infusionExperimental Treatment1 Intervention

The investigational products are (1) an intravenous infusion of granulocyte colony-stimulating factor (GCSF)-mobilized, Miltenyi-enriched CD34+ cells (≥ 5 million cells per kilogram) followed by (2) an infusion of CD3+ cells (5 million cells per kilogram) from an HLA-identical sibling living donor. The cells are infused around Day 11 post-transplant after the following pre-conditioning regimen: 1. 5 doses of rATG (1.5 mg/kg IV per day for 5 days, starting on the day of transplant) 2. 10 doses of TLI (120 centigray \[cGY\] x 10 fractions, starting the day after transplant)

0 / 18Eligibility criteria met