Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing EVE-Treg for Graft Versus Host Disease (cGvHD)

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.

Official registry: https://clinicaltrials.gov/study/NCT06991361 · Sarah Nikiforow, MD · enrollment listed as 21

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are EVE-Treg. The registry lists allocation as randomized. 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.

They plan to enroll about 21 people at Boston. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: EVE-Treg

Primary outcome (registry wording): Safety of EVE-Treg

Who it is for (from inclusion criteria)

  • Ages 2 Years to any
  • Recipient of 7-8/8 HLA-matched allogeneic hematopoietic stem cell transplantation or recipient of haploidentical allogenic hematopoietic stem cell transplantation
  • 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
  • Donor who is willing and cleared to donate starting material for manufacture of EVE-Treg

Public study contact (from the registry)

Brandi Bratrude

617-919-2197

brandi.bratrude@childrens.harvard.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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NCT00106925 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)

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NCT00923507 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)

FAQ about this NCT record

Is NCT06991361 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06991361?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06991361?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary