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Recruiting NCT06991361

Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD

Phase I Interventional Graft Versus Host Disease (cGvHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EVE-Treg.
Who it may be relevant to
Registry conditions: Graft Versus Host Disease (cGvHD). Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Trial of Ex Vivo-Expanded (EVE) Regulatory T Cells in Combination With Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease

Overview

Hematopoietic Stem Cell Transplant (HCT) has been used to treat children and adults who have leukemia, lymphoma and other cancers of blood and immune cells since the 1970s. For many of these forms of cancer, HCT works well. However, HCT can cause serious, sometimes life-threatening complications. One of the most serious and common complications of HCT is graft-versus-host disease (GVHD). GVHD can appear early after the transplant, usually about 3 to 4 weeks after the transplant is given. This is called acute GVHD (aGVHD), because it usually happens over a couple of days. If successfully treated, acute GVHD quickly goes away. Sometimes GVHD happens months after the transplant. Then it is called chronic GVHD (cGVHD), because it happens gradually and goes away slowly. The investigators are doing this study to see if one dose of Ex vivo-Expanded Regulatory T cells (EVE-Treg) can be used together with the daily Interleukin 2 (IL-2) to treat cGVHD, that has not responded to steroid treatment or low-dose IL-2.

Interventions

  • Biological EVE-Treg
    Ex Vivo-Expanded (EVE) Regulatory T cells.

Primary outcome measures

  • Safety of EVE-Treg [Time frame: 5 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Dana-Farber Cancer Institute — Boston

Identifiers

NCT: NCT06991361 · IRB00025318

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗