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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Leslie Kean
Study ID
NCT06991361
Phase
PHASE1
Status
Recruiting
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Conditions

  • Graft Versus Host Disease (cGvHD)

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 27, 2025
Start date
May 29, 2026
Status verified
Jul 2026
Primary completion
May 1, 2029
Completion
May 1, 2031

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115
Brandi Bratrude
[email protected]
617-919-2197
Sarah Nikiforow, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Dana-Farber Cancer Institute· Boston, MA

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