Cytotoxic T Lymphocytes in Treating Patients with Malignancies with BK and/or JC Virus
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.
Inclusion Criteria
- Age >= 2 years
- English and non-English speaking patients are eligible
- One of the following patient statuses: * 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 polyomavirus (PML)/JC virus encephalitis
- One of the following conditions: * Microscopic or greater hematuria and urine or blood polymerase chain reaction (PCR) positive for BK virus * Biopsy proven BK nephritis and urine or blood PCR positive for BK virus * Definite or probable PML/JC viral encephalitis * 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 JC virus (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 investigational new drug (IND) studies at the discretion of the principal investigator (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 antifungal 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 anti-thymocyte globulin (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 graft-versus-host disease (GVHD) grades II-IV
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02479698.
Locations matching your search criteria
United States
Texas
Houston
PRIMARY OBJECTIVE:
I. To assess the efficacy, feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched BK specific cytotoxic T lymphocyte (CTL) lines (BK-CTLs) generated by ex vivo expansion to mediate antiviral activity in immunocompromised patients, patients with any type of malignancies, and/or human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDs), and/or history of solid organ transplant with BK and JC infections.
SECONDARY OBJECTIVE:
I. To assess the persistence of the administered BK-CTLs generated by ex vivo expansion in immunocompromised patients, patients with any type of malignancies, or HIV/AIDs, and/or history of solid organ transplant with BK and JC infections.
OUTLINE:
Patients receive allogeneic BK-specific cytotoxic T-lymphocytes intravenously (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 (BK virus patients) or 4 weeks (JC virus patients) after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy. Patients with JC virus who are not solid organ transplant recipients and do not achieve response after the first CTL infusion may receive pembrolizumab IV over 30 minutes once every 4-6 weeks at the discretion of the principal investigator.
After completion of study treatment, patients are followed up periodically for 28 days (BK virus patients) or for 180 days (JC virus patients).
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationUT MD Anderson Cancer Center
Principal InvestigatorGeorge Liwei Chen
- Primary ID2014-0279
- Secondary IDsNCI-2015-01264
- ClinicalTrials.gov IDNCT02479698