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

Launched by M.D. ANDERSON CANCER CENTER · Jun 23, 2015

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with certain cancers and viral infections, specifically those caused by the BK and JC viruses. The study is looking at how effective donor cytotoxic T lymphocytes—special immune cells grown in the lab that are designed to target and kill viruses—are in helping patients who may not be responding to other treatments. This trial is open to patients of all ages and genders who have any type of cancer, a history of HIV/AIDS or solid organ transplants, or specific conditions related to the BK or JC viruses.

To participate, patients must meet certain criteria, such as having measurable disease from their cancer or active viral infections, and they should be in a stable clinical condition that allows them to reduce steroid medications. Participants can expect to receive treatment with these specially prepared immune cells and will be monitored for safety and effectiveness over a six-week period. It's important to note that patients with certain uncontrolled infections or those receiving specific recent treatments may not be eligible. Overall, this trial offers hope for patients dealing with challenging malignancies and viral infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• • Patients with microscopic hematuria OR biopsy proven BK nephritis and urine or blood polymerase chain reaction (PCR) positive for BK virus and/or JC viral encephalitis
• • 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
• • Once patients have completed 6-week safety and efficacy assessments after completion of the last anti-BK CTL infusion, patients will be eligible for enrollment on other supportive care protocols
• • Written informed consent from patient and/or signed assent from patient, parent or guardian
• • 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
• Exclusion Criteria:
• • Patients receiving prednisone \> 0.5 mg/kg/day at time of enrollment, or have received anti-thymocyte globulin (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 graft-versus-host disease (GVHD) grades II-IV