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

Acquired Immunodeficiency Syndrome; BK Virus Infection; Human Immunodeficiency Virus; 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

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)

Laboratory Biomarker Analysis OTHER

Correlative studies

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; and/or Non-immunocompromised patients with PML/JC virus Encephalitis; and/or patients with any type of malignancies; and/or HIV/AIDs; and/or history of solid organ transplant; and/or Merkel polyoma-virus related Merkel cell tumor(s) with measurable disease on imaging per RECIST criteria.
• Patients with microscopic hematuria OR biopsy proven BK nephritis and urine or blood PCR positive for BK virus and/or JC viral encephalitis and/or JC end-organ disease and/or polyomavirus.
• Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day of prednisone.
• Patients who are currently receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion.
• Written informed consent and/or signed assent from patient, parent or guardian. Patients with cognitive impairments are eligible.
• Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing 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 may be re-enrolled in the protocol should the infection re-occur, provided they meet all the other eligibility criteria at the moment of re-enrollment.

You may not qualify if:

• Patients receiving prednisone \> 0.5 mg/kg/day at time of enrollment, or have received ATG within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
• Patients with other uncontrolled infections (except HIV/AIDS). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as 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 progressing 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 (2)

• 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

• Amanda Olson

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda L. Olson, MD

CONTACT

713-792-8750; ALOlson@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: November 18, 2025

Record last verified: 2025-11

Locations

US (1)