Recruiting
Phase 1

EVE-Treg & IL-2

Sponsor:

Leslie Kean

Code:

NCT06991361

Conditions

Graft Versus Host Disease (cGvHD)

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Interventions

EVE-Treg

Study Details

Brief summary:

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.

Conditions

Graft Versus Host Disease (cGvHD)

Study ID

NCT06991361

Start date

May 29, 2026

Status verified date

Jul, 2026

Completion date

May 1, 2031

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

21 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Level A

EVE Treg Cell dose level A

experimental: Dose Level B

EVE Treg Cell dose level B

experimental: Dose Level C

EVE Treg Cell dose level C.

Interventions

EVE-Treg

Ex Vivo-Expanded (EVE) Regulatory T cells.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Brandi Bratrude

617-919-2197brandi.bratrude@childrens.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Brandi Bratrude

617-919-2197brandi.bratrude@childrens.harvard.edu

Principal Investigator:

Sarah Nikiforow, MD, PhD

More Information

Sponsor

Leslie Kean

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Leslie Kean on 2026-07-23.