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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Sumithira Vasu
Study ID
NCT03665675
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
1 Year - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes — BIOLOGICAL
    Given intravenously
  • Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes — BIOLOGICAL
    Given intravenously

Study Details

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.

Key Dates

Start date
Nov 7, 2020
Status verified
Mar 2026
Primary completion
Aug 20, 2026
Completion
Dec 20, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (CMV-specific CTLs)
    Participants receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days.
  • Experimental: Treatment (AdV-specific CTLs)
    Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days.

Primary Outcome Measure

Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0 [ Time Frame: Up to 30 days post infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Chris Ouellette, MD
Melinda Triplet, RN, BSN
[email protected]
614-722-6039
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

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By research site
Nationwide Children's Hospital· Columbus, OHOhio State University Comprehensive Cancer Center· Columbus, OH

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