Actively Recruiting

Phase 2
All Genders
NCT02479698

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

Led by M.D. Anderson Cancer Center · Updated on 2025-11-18

100

Participants Needed

1

Research Sites

627 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 2 years or older, including English and non-English speakers
  • Immunocompromised patients and/or patients with PML/JC virus encephalitis
  • Patients with any type of malignancies, HIV/AIDS, history of solid organ transplant, or Merkel cell carcinoma with measurable disease
  • Patients with microscopic hematuria or biopsy-proven BK nephritis and urine or blood PCR positive for BK virus and/or JC viral encephalitis or JC end-organ disease or polyomavirus
  • Clinical condition allowing steroid tapering to less than 0.5 mg/kg/day of prednisone
  • Patients currently receiving cidofovir, leflunomide, or other antiviral therapy without response
  • Written informed consent or signed assent from patient, parent, or guardian; patients with cognitive impairments are eligible
  • Negative pregnancy test for females of childbearing potential and willingness to use effective contraception during the study
  • Patients may be enrolled on other IND studies at the investigator's discretion
  • Patients may be re-enrolled if infection recurs and eligibility criteria are met
Not Eligible

You will not qualify if you...

  • Patients receiving prednisone at doses greater than 0.5 mg/kg/day at enrollment
  • Patients who have received ATG within 14 days before enrollment
  • Patients who have received donor lymphocyte infusion or Campath within 28 days before enrollment
  • Patients with uncontrolled infections other than HIV/AIDS
  • For bacterial infections, patients must be on definitive therapy with no signs of progressing infection for at least 72 hours before enrollment
  • For fungal infections, patients must be on systemic antifungal therapy with no signs of progressing infection for at least 1 week before enrollment
  • Patients with active acute graft-versus-host disease (GVHD) grades II-IV

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Amanda L. Olson, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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