NCT07366801RecruitingPhase 2/3
Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies
Pilot Study of Co-Infusion of Donor Lymphocytes Enriched With Regulatory T Lymphocytes With Ex-vivo CD3-Depleted Hematopoietic Stem Cell Graft for the Prevention of Graft-versus-Host Disease in Children With Hematopoietic and Lymphoid Tissue Neoplasms
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
Two key methods of GVHD prevention in allogeneic HSCT have a number of limitations: ex vivo T depletion is associated with an excess of infectious complications, and pharmacological immunosuppression with insufficient efficacy of GVHD prevention. Modern graft engineering technologies make it possible to create a graft with a balanced cell composition, reducing the risk of adverse events, in particular, severe forms of acute and chronic GVHD, while preserving the immunological function of the graft. In the proposed concept, enrichment of the T graft with regulatory cells will reduce the risk of GVHD and preserve a sufficient number of T lymphocytes in the graft for the formation of protective anti-infective immunity in the early stages after HSCT. The combination of partial T depletion and pharmacological immunosuppression minimized in volume and duration will combine the advantages of T depletion (early engraftment, low risk of GVHD, low risk of organ complications) and pharmacological prophylaxis (restoration of anti-infective immunity).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 7 Jan 2026
- Start date
- 3 Sept 2025
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- NCT number
- NCT07366801
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 64
- From 3 Sept 2025 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute viral hepatitis or acute HIV infection
- Life-threatening infection
- Severe (\>?) pathology of the central nervous system (epilepsy, dementia, organic damage to the central nervous system)
Lab values
- Bilirubin \>3 normal
- Creatinine \>3 norms
Other
- Hypoxemia with SaO2 \<90%
- Pregnancy and lactation
- Karnofsky score or Lansky score \<70%
Who the study is looking for
- Informed consent signed by the patient (age 14 to 25 years) and/or his/her legal representative (age 0 to 18 years).
- The patient has an indication for allogeneic hematopoietic stem cell transplantation (HSCT) established in accordance with the current regulatory framework
- Planned HSCT from a haploidentical donor
- The Karnofsky or Lansky score is more than 70%
- Life expectancy of at least 8 weeks
- Heart function: ejection fraction of at least 40%
- Consent to continue follow-up for 3 years
Age in the registry: 1 year to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198 Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.