Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

NCT02479698 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2014-0279NCI-2015-01264
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

BK Virus Infection; Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome; JC Virus Infection; Malignant Neoplasm; Merkel Cell Carcinoma; Merkel Cell Polyomavirus Infection; Viral Encephalitis

Outcome Measures

Primary Outcomes (3)

• Response, defined as response (R) = (best response [R1] or second best response [R2])

  The method of Thall et al will be used to monitor the probabilities of response.

  Up to 56 days

• Incidence of acute graft-versus-host disease (GVHD)

  The method of Thall et al will be used to monitor the probabilities of grade 3 or 4 GVHD.

  Within 28 days of the last dose of cytotoxic T lymphocytes (CTLs)

• Incidence of adverse events

  Will be continuously monitored.

  Up to day 100

Secondary Outcomes (2)

• Overall survival

  Up to 12 months

• Glomerular filtration rate

  Up to 12 months

Study Arms (1)

Treatment (BK-specific cytotoxic T lymphocytes)

EXPERIMENTAL

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.

Biological: Allogeneic BK-specific Cytotoxic T-lymphocytes; Other: Laboratory Biomarker Analysis

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (BK-specific cytotoxic T lymphocytes)

Allogeneic BK-specific Cytotoxic T-lymphocytes BIOLOGICAL

Given IV

Also known as: Allogeneic BK-CTLs, Allogeneic BK-specific CTLs

Treatment (BK-specific cytotoxic T lymphocytes)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (3)

• Olson 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 DERIVED

• Olson 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 DERIVED

• Muftuoglu 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 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Neoplasms; Carcinoma, Merkel Cell; Encephalitis, Viral

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Polyomavirus Infections; DNA Virus Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• George Chen, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Chen, MD

CONTACT

713-792-3630; GLChen1@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 24, 2015
• Study Start: July 23, 2015
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-08

Locations

US (1)