NCT07685457Toboroz
Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
A Prospective Clinical Study to Evaluate the Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 6.
Rövid összefoglaló (regiszter, angolul)
The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are: * What is the maximum tolerated dose of LB-DTK-MV based on dose-limiting toxicity? * What treatment emergent adverse events occur within 14 days after the second infusion? * Is there a clinically significant reduction in CMV, EBV, and BKV viral loads within 14 days following the second infusion? * Is there a clinically significant improvement in clinical symptoms within 14 days following the second infusion? Participants will: * Receive a single intravenous infusion of LB-DTK-MV during the baseline visit (low dose: 1x10\^7/m\^2; high dose: 2x10\^7/m\^2). * Receive the second infusion of LB-DTK-MV intravenously at the same dose 14 days after the first infusion. * Attend weekly follow-up visits at the clinic for 6 months after the first infusion.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 6 (tervezett)
- Első benyújtás
- 2026. jún. 29.
- Kezdés
- 2026. febr. 10.
- Elsődleges befejezés
- 2027. máj. 20.
- Fő szponzor
- LucasBio
- NCT-szám
- NCT07685457
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 6
- 2026. febr. 10. és az elsődleges befejezés (2027. máj. 20.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.
Más betegség
- Patients with active graft-versus-host disease (GvHD) of grade 2 or higher.
- Patients with active malignant tumor or uncontrolled recurrence.
Laborértékek
- Patients with organ failures and/or uncontrolled bacterial or fungal infections.
- Moderate or severe liver damage [Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN)]
- Chronic kidney disease [eGFR < 30mL/min/1.73m\^2]
- Patients who have undergone allogeneic hematopoietic stem cell transplantation or received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose.
Egyéb
- Patients deemed ineligible for participation in this clinical study by the investigator.
Kiket keres a vizsgálat
- Patients with CMV, EBV, and/or BKV infection that is resistant or refractory to standard-of-care treatment and associated with severe complications following allogeneic hematopoietic stem cell transplantation at the ages of 1-25 years.
- Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5x10\^3/μL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation at least 21 days prior to the screening visit.
- Patients who show complete donor chimerism (PCR-short tandem repeats ≥ 95%) at the time of first dose administration.
- Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
- Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.
- For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
- Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).
Életkor a regiszterben: 1 év – 25 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | Dél-Korea | Toboroz |
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