Recruiting
Phase 2

Cytotoxic T Lymphocytes

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT02479698

Conditions

Acquired Immunodeficiency Syndrome

BK Virus Infection

Human Immunodeficiency Virus

JC Virus Infection

Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Allogeneic BK-specific Cytotoxic T-lymphocytes

Laboratory Biomarker Analysis

Study Details

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

Study ID

NCT02479698

Start date

Jul 23, 2015

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients ≥ 2 years.
  • English and non-English speaking patients are eligible.
  • Immunocompromised patients including but not limited to those with any type of malignancy, HIV/AIDS, or history of solid organ transplant
  • Non-immunocompromised patients with PML/JC virus encephalitis
  • Microscopic or greater hematuria urine or blood PCR positive for BK virus
  • Biopsy proven BK nephritis and urine or blood PCR positive for BK virus disease and/or polyomavirus.
  • Definite or probable PML/JC viral encephalitis (see Appendix C)
  • JC end-organ disease
  • Receiving > 6 mg / day of prednisone or equivalent at the time of enrollment.
  • Patients with BK virus hemorrhagic cystitis, who are receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion.
  • Patients with JCV encephalitis / PML may be receiving pembrolizumab.
  • Written informed consent and/or signed assent from patient, parent or guardian.
  • Patients with cognitive impairments are eligible.
  • A negative pregnancy test in female patients of childbearing potential. Childbearing potential is defined as pre-menopausal, post-menopausal for < 1 year, and not having undergone surgical sterilization.
  • Women of childbearing 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 with bacterial infections must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.
  • Patients with fungal infections patients must be receiving definitive systemic anti fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
  • Patients may be re-enrolled in the protocol if the BK or JC virus infection recurs, so long as they meet all the other eligibility criteria at the time of re-enrollment.

Exclusion Criteria:

  • Patients receiving > 6 mg / day of prednisone or equivalent at time of
  • Patients who have received ATG within 14 days of enrollment
  • Patients who have received donor lymphocyte infusion (DLI) within 28 days of enrollment.
  • Patients who have received alemtuzumab within 28 days of enrollment.
  • Patients with other uncontrolled infections (including HIV/AIDS). Uncontrolled infection is defined as the presence of 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 uncontrolled infection.
  • Patients with active acute GVHD grades II-IV.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (BK-specific cytotoxic T lymphocytes)

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.

Interventions

Allogeneic BK-specific Cytotoxic T-lymphocytes

Given IV

Laboratory Biomarker Analysis

Correlative studies

Primary outcome measure

  • Response, defined as response (R) = (best response [R1] or second best response [R2]) [ Time Frame: Up to 56 days ]
  • Incidence of acute graft-versus-host disease (GVHD) [ Time Frame: Within 28 days of the last dose of cytotoxic T lymphocytes (CTLs) ]
  • Incidence of adverse events [ Time Frame: Up to day 100 ]

Central Contacts and Locations

Central contacts

George Chen, MD

713-792-3630GLChen1@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

George Chen, MD

713-792-3630GLChen1@mdanderson.org

Principal Investigator:

George Chen

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Sep 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-09-04.