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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02479698
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acquired Immunodeficiency Syndrome
  • BK Virus Infection
  • Human Immunodeficiency Virus
  • JC Virus Infection
  • Malignant Neoplasm
  • Merkel Cell Carcinoma
  • Merkel Cell Polyomavirus Infection
  • Viral Encephalitis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic BK-specific Cytotoxic T-lymphocytes — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Jul 23, 2015
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Response, defined as response (R) = (best response [R1] or second best response [R2]) [ Time Frame: Up to 56 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Amanda Olson
713-792-8750
Amanda Olson (PRINCIPAL_INVESTIGATOR)

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