NCT03665675

Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT

Pilot Study of Haploidentical or Matched Donor Virus-Specific T-cells (Cytomegalovirus (CMV) or Adenovirus (AdV)) to Treat CMV or AdV Reactivation or Disease in Patients After Solid Organ or Hematopoietic Stem Cell Transplantation (HCT)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sumithira Vasu · Academic / Other
• Sex: All
• Age: 1 Year – 85 Years
• Healthy volunteers: Accepted

Summary

This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus \[CMV\] specific cytotoxic T-lymphocytes \[CTLs\]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific \[AdV\] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.

Detailed description

PRIMARY OBJECTIVE I. Assess the safety and feasibility of administering virus specific-CTLs from haploidentical donors in transplant patients both solid organ transplantation (SOT) and hematopoietic cell transplantation (HCT) with CMV/AdV infection despite standard therapy. OUTLINE:Patients are assigned to 1 of 2 Cohorts. COHORT A: Patients receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes intravenously (IV). Patients undergo blood, urine, saliva, cerebrospinal fluid (CSF), and bronchoalveolar fluid sample collection on the trial. COHORT B: Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Patients undergo blood, urine, saliva, CSF, and bronchoalveolar fluid sample collection on the trial. After completion of study treatment, participants are followed up at 1 year.

Conditions

• Allogeneic Hematopoietic Stem Cell Transplantation Recipient
• Cytomegalovirus
• Donor
• Solid Organ Transplantation Recipient
• Adenovirus

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes	Given intravenously
BIOLOGICAL	Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes	Given intravenously

Timeline

• Start date: 2020-11-07
• Primary completion: 2026-08-20
• Completion: 2026-12-20
• First posted: 2018-09-11
• Last updated: 2026-04-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study