RecruitingEarly Phase 1NCT03665675

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)


Sponsor

Sumithira Vasu

Enrollment

20 participants

Start Date

Nov 7, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is offering an immune cell therapy for transplant patients who develop serious viral infections — specifically cytomegalovirus (CMV) or adenovirus (AdV) — after a solid organ or bone marrow transplant. After transplants, patients must take immunosuppressive drugs to prevent rejection, which leaves them vulnerable to viral reactivation. This therapy uses virus-specific T-cells (cytotoxic lymphocytes, or CTLs) derived from a matched donor to help fight the infection. The CTLs are grown from a donor who has immunity to the specific virus, then infused into the patient. This approach targets the virus directly without the broad immune suppression that conventional antiviral drugs cause. You may be eligible if: - You are between 1 and 85 years of age - You have had a solid organ transplant or allogeneic stem cell transplant - You have documented CMV or adenovirus infection or reactivation that is not responding to antiviral treatment, or you cannot tolerate standard antiviral drugs - A suitable seropositive (immune) haploidentical or matched donor is available You may NOT be eligible if: - You have received T-cell depleting drugs (e.g., ATG, alemtuzumab) within the past 21 days - You are on high-dose steroids (> 0.5 mg/kg/day prednisone or equivalent) - You have a severe uncontrolled bacterial or fungal infection - You have active acute graft-versus-host disease (grades II-IV) requiring intensive immunosuppression - You have active, uncontrolled cancer relapse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes

Given intravenously

BIOLOGICALAllogeneic Adenovirus-specific Cytotoxic T Lymphocytes

Given intravenously


Locations(2)

Nationwide Children's Hospital

Columbus, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT03665675


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