Clinical trial · Interventional
Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus
Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection
- 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)
This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acquired Immunodeficiency Syndrome | — | UNRESOLVED | — |
| BK Virus Infection | — | UNRESOLVED | — |
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
| JC Virus Infection | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Merkel Cell Polyomavirus Infection | — | UNRESOLVED | — |
| Viral Encephalitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic BK-specific Cytotoxic T-lymphocytes | Biological | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (BK-specific cytotoxic T lymphocytes)
- description
- Patients receive allogeneic BK-specific cytotoxic T-lymphocytes IV over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 19 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy.
- interventionNames
- Biological: Allogeneic BK-specific Cytotoxic T-lymphocytes
- Other: Laboratory Biomarker Analysis
Primary outcomes (3)
- measure
- Response, defined as response (R) = (best response [R1] or second best response [R2])
- timeFrame
- Up to 56 days
- description
- The method of Thall et al will be used to monitor the probabilities of response.
- measure
- Incidence of acute graft-versus-host disease (GVHD)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 2 years. * English and non-English speaking patients are eligible. * Immunocompromised patients including but not limited to those with any type of malignancy, HIV/AIDS, or history of solid organ transplant * Non-immunocompromised patients with PML/JC virus encephalitis * Microscopic or greater hematuria urine or blood PCR positive for BK virus * Biopsy proven BK nephritis and urine or blood PCR positive for BK virus disease and/or polyomavirus. * Definite or probable PML/JC viral encephalitis (see Appendix C) * JC end-organ disease * Receiving \> 6 mg / day of prednisone or equivalent at the time of enrollment. * Patients with BK virus hemorrhagic cystitis, who are receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion. * Patients with JCV encephalitis / PML may be receiving pembrolizumab. * Written informed consent and/or signed assent from patient, parent or guardian. * Patients with cognitive impairments are eligible. * A negative pregnancy test in female patients of childbearing potential. Childbearing potential is defined as pre-menopausal, post-menopausal for \< 1 year, and not having undergone surgical sterilization. * Women of childbearing potential must be willing to use an effective contraceptive measure while on study. * Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI. * Patients with bacterial infections must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. * Patients with fungal infections patients must be receiving definitive systemic anti fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. * Patients may be re-enrolled in the protocol if the BK or JC virus infection recurs, so long as they meet all the other eligibility criteria at the time of re-enrollment. Exclusion Criteria: * Patients receiving \> 6 mg / day of prednisone or equivalent at time of * Patients who have received ATG within 14 days of enrollment * Patients who have received donor lymphocyte infusion (DLI) within 28 days of enrollment. * Patients who have received alemtuzumab within 28 days of enrollment. * Patients with other uncontrolled infections (including HIV/AIDS). Uncontrolled infection is defined as the presence of hemodynamic instability attributable to sepsis, or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as uncontrolled infection. * Patients with active acute GVHD grades II-IV.
References
Publications (3)
- DERIVEDOlson A, Li Y, Marin D, Thall PF, Bassett RL, Barnett M, Basar R, Banerjee PP, Kleiman TA, Chen M, Rexer J, Wintermark M, Choi J, Learned K, Kaur I, Sylejmani M, Abueg G, Chemaly RF, Mulanovich V, Shrestha R, Uprety N, Castro KM, Daher M, Galvan IM, Washington D, Champlin RE, Shpall EJ, Rezvani K. Treatment of Progressive Multifocal Leukoencephalopathy with Third-Party Allogeneic BK Virus T Cells. Clin Infect Dis. 2026 Jul 6:ciag404. doi: 10.1093/cid/ciag404. Online ahead of print. PMID 42402341
- DERIVEDOlson A, Lin R, Marin D, Rafei H, Bdaiwi MH, Thall PF, Basar R, Abudayyeh A, Banerjee P, Aung FM, Kaur I, Abueg G, Rao S, Chemaly R, Mulanovich V, Al-Atrash G, Alousi AM, Andersson BS, Anderlini P, Bashir Q, Castro KM, Daher M, Galvan IM, Hosing C, Im JS, Jones RB, Kebriaei P, Khouri I, Mehta R, Molldrem J, Nieto Y, Oran B, Popat U, Qazilbash M, Rondon G, Saini N, Spencer B, Srour S, Washington D, Barnett M, Champlin RE, Shpall EJ, Rezvani K. Third-Party BK Virus-Specific Cytotoxic T Lymphocyte Therapy for Hemorrhagic Cystitis Following Allotransplantation. J Clin Oncol. 2021 Aug 20;39(24):2710-2719. doi: 10.1200/JCO.20.02608. Epub 2021 Apr 30. PMID 33929874
- DERIVEDMuftuoglu M, Olson A, Marin D, Ahmed S, Mulanovich V, Tummala S, Chi TL, Ferrajoli A, Kaur I, Li L, Champlin R, Shpall EJ, Rezvani K. Allogeneic BK Virus-Specific T Cells for Progressive Multifocal Leukoencephalopathy. N Engl J Med. 2018 Oct 11;379(15):1443-1451. doi: 10.1056/NEJMoa1801540. PMID 30304652