Lab-grown immune cells take on seven viruses in transplant patients
NCT ID NCT03180216
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This early-stage study tests whether immune cells grown from a donor's blood can safely fight or prevent seven different viruses in people who have had a bone marrow transplant. About 32 participants will receive these cells either as a preventive measure or as a treatment for active infections that did not get better with standard care. The main goal is to check for side effects, such as graft-versus-host disease or other serious reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2017
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Recipient Inclusion Criteria at the Time of Initial VST Infusion and Subsequent Infusions: 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells no earlier than 5 days prior to the date of VST infusion. VSTs administered as: 1. Prophylaxis for patients at risk of EBV, CMV, adenovirus, HHV6, BKV, JCV and/or HPIV3. 2. Treatment of reactivation or active infection(s) with EBV, CMV, adenovirus, HHV6, BKV, JCV, and/or HPIV3 that has failed to resolve with at least 14 days of standard antiviral therapy (if available and tolerated). Patients with multiple infections due to the targeted viruses are also eligible. 2. Clinical status at infusion allows for tapering of steroids to less than 0.5 mg/kg/day prednisone or equivalent. 3) Karnofsky/Lansky score of ≥ 50. 4\) Bilirubin ≤ 2x, AST ≤5x, Serum creatinine ≤2x upper limit of normal, Hgb ≥8.0 g/dL (level can be achieved with transfusion). 5\) Pulse oximetry of \> 90% on room air. 6) Available multivirus-specific cytotoxic T lymphocytes 7) Negative pregnancy test (if female of childbearing potential). 8) Patient or parent/guardian capable of providing informed consent. Recipient Exclusion Criteria at the Time of Initial VST Infusion and Subsequent Infusions 1. Patients with other uncontrolled infections. 2. Patients who received ATG, Campath, Basiliximab or other T cell immunosuppressive monoclonal antibodies within 28 days prior to VST infusion. 3. Received donor lymphocyte infusion or other cellular therapies (with the exception of allogeneic cells related to transplantation) within 28 days prior to VST infusion. 4. Evidence of acute GVHD grades II-IV. 5. Active and uncontrolled relapse of malignancy. 6. Patients with Grade ≥ 3 hyperbilirubinemia. 7. Patients who have received investigational (IND) product within 28 days prior VST infusion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Childrens National Medical Center
Washington D.C., District of Columbia, 20010, United States
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Other studies related to the condition(s) this trial covers.
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