Antigen Specific Adoptive T Cell Therapy for Refractory Opportunistic Adenovirus Infection After a Hematopoietic Stem Cell Transplantation

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The purpose of this study is to determine if it is possible to treat an infection with a cell-based immunotherapy (therapy that uses the patient's own immune system to treat the infection). This treatment is called adoptive T cell therapy. Another purpose is to learn about the side effects and toxicities of adoptive T cell therapy. Adoptive T cell therapy is an investigational (experimental) therapy that works by using the blood of a donor that has immunity against the virus. The donor cells are collected and then the cells, called T cells, that are capable of defending against the virus are selected out. These selected T cells are then infused back into the patient, to try to give the immune system the ability to fight the infection. Adoptive T cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Healthy Volunteers: f
View:

• Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration.

• Patients must have evidence of documented HAdV infection/reactivation. Patients may be:

‣ Symptomatic with any detectable viral load OR

⁃ Asymptomatic with viral load that is:

∙ \>1000 copies/ml in peripheral blood OR qualitative detection in stool, urine and/or other specimens

• Patients must have poor response and/or contraindication to therapy:

‣ Absence of an improvement of viral load (decrease by at least 1 log, i.e. 10-fold) after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir and/or foscarnet. OR

⁃ New, persistent and/or worsening HAdV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet. OR

⁃ Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir, cidofovir or foscarnet.

• Performance Score: Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 3. Karnofsky (≥ 16 years) or Lansky (\<16 years) performance score ≥ 50

• The effects of virus-specific, antigen-selected T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.

• Subjects who are 14 years and older must have the ability to understand and the willingness to sign a written informed consent document, or assent document.

Locations
United States
Ohio
University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Mari H Dallas, MD
mhd27@case.edu
216-844-0139
Time Frame
Start Date: 2019-01-04
Estimated Completion Date: 2028-12
Participants
Target number of participants: 20
Treatments
Experimental: Interferon (IFN)-gamma-secreting HAdV antigen specific T cells
Virus-specific, antigen selected cells will be obtained using the CliniMACS® Prodigy System. The donor will be screened for their ability to produce an IFN-gamma- secretion response to HAdV by testing the donor's mononuclear cells with the Miltenyi Rapid Cytokine Inspector kit. Donors with appropriate IFN-gamma secretion response will undergo a steady state leukapheresis. The investigational product (IP) will be generated using the CCS-IFN enrichment program with an approximate duration time of 15 hours. IP will be suspended in 0.9 normal saline + 2.5% albumin and distributed for infusion and infused within 4 hours as a bolus on day 0.~Subjects will receive virus-specific, antigen selected T cells within a targeted range of 1 x 10\^3- 2 x 10\^5 per kg of recipient weight.
Related Therapeutic Areas
Sponsors
Leads: Mari Dallas

This content was sourced from clinicaltrials.gov