What is this study trying to find out about malignancies with BK and/or JC virus?

This study is evaluating how well donor-derived cytotoxic T lymphocytes work for treating patients with malignancies who have BK and/or JC virus infections. Researchers want to understand if these specially grown immune cells can target these viruses effectively in patients with cancer, HIV/AIDS, or transplant history. The study is sponsored by M.D. Anderson Cancer Center and aims to assess treatment effects and safety.

Who may be eligible for this malignancy clinical trial?

Adults and children aged 2 years and older with malignancies, HIV/AIDS, a history of solid organ transplant, or Merkel cell tumors may be eligible. Participants must have BK or JC virus infections confirmed by lab tests and be able to reduce steroid use to below 0.5 mg/kg/day. People with certain active infections or high steroid doses are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this malignancy clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs during the trial.

Actively Recruiting

Phase 2

All Genders

ID02479698

Phase 2 Study of Donor-Derived BK-Specific Cytotoxic T Lymphocytes for Treating Patients With Malignancies, HIVAIDS, or Transplants Infected With BK or JC Virus

Led by M.D. Anderson Cancer Center · Updated on 2026-06-12

100

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of donor cytotoxic T lymphocytes CTLs to treat patients who have malignancies associated with BK andor JC virus infections. These CTLs are specially grown from donated blood cells to target viruses that often cause infections in transplant patients. The study aims to assess the effectiveness, feasibility, and safety of these BK-specific CTLs administered to patients with various malignancies, HIVAIDS, or a history of solid organ transplant who have BK and JC infections. Participants will receive allogeneic BK-specific cytotoxic T-lymphocytes through an intravenous infusion lasting about 30 minutes. Those showing partial response, stable disease, or progression may receive up to 19 additional CTL infusions at least two weeks apart if they remain eligible. After completing the CTL treatments, participants will be followed for up to 12 months to monitor health and treatment effects. During the study, participants will undergo regular assessments including response evaluation within 56 days, monitoring for graft-versus-host disease within 28 days after the last infusion, and adverse event tracking up to 100 days. Additional measures include overall survival and kidney function tests monitored up to 12 months after treatment. The study includes laboratory biomarker analyses to support correlative research and involves periodic follow-up visits to track participants health and treatment outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

Patients aged 2 years or older
Immunocompromised patients or non-immunocompromised patients with PML/JC virus encephalitis
Patients with any type of malignancies, HIV/AIDS, history of solid organ transplant, or Merkel cell tumors with measurable disease
Patients with microscopic hematuria or biopsy-proven BK nephritis and positive BK virus or JC viral encephalitis/end-organ disease
Clinical status allowing steroid tapering to less than 0.5 mg/kg/day prednisone
Patients currently treated with cidofovir, leflunomide, or other antivirals with no response
Written informed consent or assent obtained
Negative pregnancy test for women of childbearing potential and use of effective contraception
Patients may be enrolled in other IND studies at the PI's discretion
Patients may be re-enrolled if infection recurs and criteria are met

You will not qualify if you...

Patients receiving prednisone over 0.5 mg/kg/day at enrollment
Patients who received ATG within 14 days or donor lymphocyte infusion (DLI) or Campath within 28 days
Patients with uncontrolled infections except HIV/AIDS
For bacterial infections, must be on definitive therapy and no signs of progression for 72 hours
For fungal infections, must be on systemic therapy and no signs of progression for 1 week
Signs of progressing infection include hemodynamic instability or worsening symptoms
Patients with active acute graft-versus-host disease grades II-IV

Research Team

George Chen, MD

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