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

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJohn Koreth, MBBS, DPhil

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?This research study is a Phase I clinical trial, which tests the safety of an investigational combination of IL-2 plus donor anti-inflammatory Treg cells and also tries to define the appropriate dose of the investigational combination of IL-2 plus donor anti-inflammatory Treg cells to use for further studies. IL-2 is involved with cell signaling and regulation of white blood cells (WBCs). WBCs are part of the immune system. Treg cells are also part of the immune system; they are involved with anti-inflammatory responses. "Investigational" means that the combination of IL-2 and anti-inflammatory Treg cell infusion is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved the combination of IL-2 and anti-inflammatory Treg cell infusion for use in people with cGVHD. Chronic GVHD is a medical condition that may occur after you have received your bone marrow, stem cell or cord blood transplant from a donor. The donor's immune system may recognize your body (the host) as foreign and attempt to 'reject' it. This process is known as graft-versus-host disease. Traditional standard therapy to treat cGVHD is prednisone (steroids). Participants on this trial have not responded to steroid therapy. The investigators are looking to assess the safety and optimal dose for the combination of IL-2 plus donor anti-inflammatory Treg cells, that may help control cGVHD by stopping the donor's immune system from 'rejecting' your body.

Eligibility Criteria

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.

Inclusion Criteria

I have been on a stable dose of steroids for at least 4 weeks.

Agreement to use adequate contraception for the duration of study participation

Ability to understand and the willingness to sign a written informed consent document

+6 more

Exclusion Criteria

I have a history of blood clotting disorders.

Other investigational drugs within 4 weeks prior to enrollment

Pregnant women or breastfeeding individuals

+12 more

Participant Groups

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.

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).

Interleukin-2 is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Aldesleukin for: