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Cytokine

Treg Cells + IL-2 for Graft-versus-Host Disease

Phase 1

Waitlist Available

Led By John Koreth, MBBS, DPhil

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Recipient of allogeneic hematopoietic stem cell transplantation

Participants must have steroid-refractory cGVHD defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at ≥ 0.25 mg/kg/day for at least 4 weeks

Must not have

History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura

Active malignant relapse

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of the IL-2/Treg cell infusion and finding the best dose to use.

Who is the study for?

This trial is for adults over 18 with chronic GVHD that hasn't improved with steroids. They must have had a stem cell transplant, be in fair health (ECOG 0-2), and not have changed their immunosuppressive meds or received new GVHD therapies recently. Pregnant women, breastfeeding individuals, those on certain drugs, or with active infections or other serious health issues can't join.

What is being tested?

The study tests the safety and optimal dose of IL-2 plus donor Treg cells to treat cGVHD by calming the immune response after a stem cell transplant. It's an early-phase trial to see if this combination can prevent the body from being 'rejected' by the donor's immune system.

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression such as increased risk of infection, possible organ inflammation due to altered immune responses, and typical infusion-related symptoms like fever or chills.

Eligibility Criteria

Inclusion Criteria

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

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I have received a stem cell transplant from a donor.

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My cGVHD symptoms didn't improve after taking steroids for 4 weeks.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

Exclusion Criteria

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

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I have a history of blood clotting disorders.

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My cancer has returned after treatment.

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I have received an organ transplant from another person.

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I am HIV-positive and on combination antiretroviral therapy.

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I do not have active, uncontrolled hepatitis B or C.

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I am currently taking calcineurin-inhibitor and sirolimus together.

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I need more than 1 mg/kg/day of prednisone.

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I currently have an infection that isn't under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse event profile and the maximum tolerate dose of Treg-enriched infusion plus 8-week low-dose IL-2

Secondary study objectives

Clinical response of cGVHD as defined by the NIH consensus criteria to Treg-enriched infusion plus 8-week low-dose IL-2

Expansion of Treg cells in the peripheral blood after a Treg-enriched infusion plus 8-week low-dose IL-2

To determine feasibility of Treg-enriched infusion plus 8-week low-dose IL-2

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: Treg-enriched infusion plus 8-week low-dose Interleukin-2Experimental Treatment2 Interventions

Treg-enriched Cell Dose: Participants will be targeted to a defined dose of donor Treg-enriched total nucleated cells. Initial enrollment will be at target dose-level A. Subsequent cohorts will be dose escalated/de-escalated per the schema. Interleukin-2: Starting the day of Treg-enriched cell infusion, each participant will receive daily subcutaneous IL-2 for self-administration for 8 weeks, followed by a 4-week hiatus. IL-2 will be administered on an outpatient basis. Expected toxicities and potential risks as well as dose modifications are described in Section 6 (Expected Toxicities and Dosing Delays/Dose Modification).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Interleukin-2

1994

Completed Phase 3

~690

0 / 12Eligibility criteria met