Clinical trial · Interventional
Third Party Viral Specific T-cells (VSTs)
Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
NCT02532452CI-TRIAL-00125879recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infection in an Immunocompromised Host | — | UNRESOLVED | — |
| Viral Infection | — | UNRESOLVED | — |
| Viral Reactivation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Viral Specific VST Infusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Viral Specific VST Infusion
- description
- 3rd party VST infusion
- interventionNames
- Biological: Viral Specific VST Infusion
Primary outcomes (3)
- measure
- Successful production of viral specific T-cells
- timeFrame
- Within 30 days post culture initiation
- description
- Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
- measure
- Percentage of patients who do not have infusional toxicity
- timeFrame
- Through 30 minutes post infusion
- description
- Patients will be monitored for infusional toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Days
Show eligibility criteria text
Inclusion Criteria: * Immunocompromised patient with evidence of viral infection or reactivation * Age \>1 day * Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion * Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent * Must be able to receive CTL infusion in Cincinnati * Informed consent obtained by PI or sub-investigator either in person or by phone Exclusion Criteria: * Active acute GVHD grades II-IV * Uncontrolled bacterial or fungal infection * Uncontrolled relapse of malignancy requiring treatment with chemotherapy * Infusion of ATG or alemtuzumab within 2 weeks of VST infusion * Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days
References
Publications (4)
- DERIVEDRubinstein JD, Pham G, Sridharan A, Khoury R, Wang YM, Hudda Z, Wilhelm J, Lichtenstein DA, Heyenbruch D, Cancelas JA, Davies SM, Lutzko C, Grimley MS. Outcomes with third-party virus-specific T cells after the use of single-antigen cell lines to predict HLA restriction. Blood Adv. 2025 Dec 23;9(24):6305-6313. doi: 10.1182/bloodadvances.2025017097. PMID 40991376
- DERIVEDGalletta TJ, Lane A, Lutzko C, Leemhuis T, Cancelas JA, Khoury R, Wang YM, Hanley PJ, Keller MD, Bollard CM, Davies SM, Grimley MS, Rubinstein JD. Third-Party and Patient-Specific Donor-Derived Virus-Specific T Cells Demonstrate Similar Efficacy and Safety for Management of Viral Infections after Hematopoietic Stem Cell Transplantation in Children and Young Adults. Transplant Cell Ther. 2023 May;29(5):305-310. doi: 10.1016/j.jtct.2023.01.027. Epub 2023 Feb 3. PMID 36736781
- DERIVEDRubinstein JD, Zhu X, Leemhuis T, Pham G, Ray L, Emberesh S, Jodele S, Thomas S, Cancelas JA, Bollard CM, Hanley PJ, Keller MD, Grimley O, Clark D, Clark T, Lindestam Arlehamn CS, Sette A, Davies SM, Nelson AS, Grimley MS, Lutzko C. Virus-specific T cells for adenovirus infection after stem cell transplantation are highly effective and class II HLA restricted. Blood Adv. 2021 Sep 14;5(17):3309-3321. doi: 10.1182/bloodadvances.2021004456. PMID 34473237
- DERIVEDNelson AS, Heyenbruch D, Rubinstein JD, Sabulski A, Jodele S, Thomas S, Lutzko C, Zhu X, Leemhuis T, Cancelas JA, Keller M, Bollard CM, Hanley PJ, Davies SM, Grimley MS. Virus-specific T-cell therapy to treat BK polyomavirus infection in bone marrow and solid organ transplant recipients. Blood Adv. 2020 Nov 24;4(22):5745-5754. doi: 10.1182/bloodadvances.2020003073. PMID 33216887