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

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    M.D. Anderson Cancer Center
Updated on 22 September 2021
cancer
cytotoxic drug
prednisone
measurable disease
cytotoxic chemotherapy
solid tumors
AIDS
cidofovir
solid tumour
solid neoplasm
HIV Vaccine
antiviral drugs
leflunomide
allogeneic bk-specific cytotoxic t-lymphocytes

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.

Description

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 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 patients with any type of malignancies, and/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 7 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy.

After completion of study treatment, patients are followed up periodically for 12 months.

Details
Condition HIV, HIV infection, Neuroendocrine carcinoma, Cancer, Viral infection, BK Virus, AIDS, Merkel cell carcinoma, Viral Encephalitis, HIV/AIDS, AIDS and AIDS related infections, Cancer/Tumors, Ewing's Family Tumors, BK Virus Infection, Merkel Cell Polyomavirus Infection, Acquired Immune Deficiency Syndrome (AIDS - Pediatric), Cancer (Pediatric), HIV (Pediatric), HIV Infections, Neoplasms, Viral Infections, JC Virus Infection, primary cancer, primary malignant neoplasm, bk viral infection, malignancy, cancers, malignancies, malignant tumor, malignant tumors, human immunodeficiency virus, hiv disease, acquired immunodeficiency syndrome (aids), sida, acquired immune deficiency syndrome (aids)
Treatment laboratory biomarker analysis, Cytotoxic T lymphocytes (CTLs), Allogeneic BK-specific Cytotoxic T-lymphocytes
Clinical Study IdentifierNCT02479698
SponsorM.D. Anderson Cancer Center
Last Modified on22 September 2021

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