Expanded regulatory T cells plus low-dose IL-2 for steroid-refractory chronic GVHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study evaluating the safety and feasibility of administering ex vivo-expanded regulatory T cells (EVE-Treg) together with low-dose interleukin-2 to patients with steroid-refractory chronic graft-versus-host disease after allogeneic hematopoietic stem cell transplantation. Participants must have had a matched or haploidentical transplant and stable steroid dosing, with active cGVHD despite prior IL-2 exposure. The study investigates whether this cell-based therapy can be delivered safely and may enable better control of cGVHD. Primary focus is on safety and tolerability, with secondary observations on clinical responses and biomarker signals. The trial is conducted at a single center and led by Dana-Farber Cancer Institute personnel.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Recipient of 7-8/8 HLA-matched allogeneic hematopoietic stem cell transplantation or recipient of haploidentical allogenic hematopoietic stem cell transplantation.
* Age 2 and up.
* Must have steroid-refractory chronic GVHD that is still active despite at least 4 weeks of treatment with low-dose subcutaneous (SC) IL-2.
* Stable dose of glucocorticoids for 2 weeks prior to enrollment
* no addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment.
* Must have adequate organ and marrow function.
* Ability to understand and willingness to sign a written informed consent form.
* Donor who is willing and cleared to donate starting material for manufacture of EVE-Treg.

Exclusion Criteria:

* Recipient of umbilical cord blood stem cell graft.
* Ongoing prednisone requirement greater than 1 mg/kg/day (or equivalent).
* Karnofsky/Lansky performance score less than 40%.
* Concurrent use of methotrexate, azathioprine, or a calcineurin-inhibitor plus sirolimus.
* Other investigational agents within 4 weeks prior to enrollment.
* Participants with post-transplant exposure to donor lymphocyte infusion, or T-cell or IL-2 targeted medications within 100 days prior to enrollment.
* Participants with new immunosupprssive medication, extra-corporeal photopheresis or rituximab therapy initiated int he 4 weeks prior to enrollment.
* Participants with active malignant relapse or recrudescence of their prior hematologic disorder.
* Uncontrolled intercurrent illness unrelated to cGVHD.
* Participants with psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant patients are excluded.

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Brandi Bratrude
• Email: brandi.bratrude@childrens.harvard.edu
• Phone: 617-919-2197

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.