Clinical trial · Interventional
Donor-Derived Viral Specific T-cells (VSTs)
Donor-Derived Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Allogeneic Stem Cell Transplant
- 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)
In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant. The investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death. Stem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find an easier way to treat these 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 |
|---|---|---|---|
| Allogeneic Stem Cell Transplant | — | 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
- Viral reactivation or infection. VST Reinfusion required.
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Weeks
Show eligibility criteria text
Inclusion Criteria: * Recipient 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 * Recipient must have achieved engraftment with ANC ≥ 500 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
References
Publications (2)
- 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