Using donor T cells to treat cancer patients with BK and JC viruses

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

This study is testing if infusions of special immune cells from donors can help cancer patients with BK or JC virus infections feel better and fight their illness.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: prednisone
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT02479698 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effectiveness of donor-derived cytotoxic T lymphocytes in treating patients with malignancies affected by BK and/or JC viruses. The study focuses on patients with various cancers, HIV/AIDS, or those with a history of solid organ transplants who are experiencing BK or JC infections. Participants will receive intravenous infusions of HLA-matched BK-specific cytotoxic T lymphocytes, with the possibility of additional infusions based on their response. The trial aims to evaluate the safety, efficacy, and persistence of these T cells in the patient's system over a 12-month follow-up period.

Who should consider this trial

Good fit: Ideal candidates include patients with any type of malignancies, HIV/AIDS, or a history of solid organ transplants who are also infected with BK or JC viruses.

Not a fit: Patients who do not have malignancies or infections related to BK or JC viruses may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with malignancies complicated by BK and JC virus infections.

How similar studies have performed: Other studies have shown promise in using T cell therapies for viral infections in immunocompromised patients, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Amanda Olson — M.D. Anderson Cancer Center
• Study coordinator: Amanda L. Olson, MD

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