Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Paul Szabolcs
Enrollment for existing UPMC patients. Ideally, subjects will receive up to ≤1 x 105 (100,000) viable CD3 cells/kg however actual cell dose of infusion will be based upon available cells and subject's clinical picture. Historically, subjects have received all available cells after the gamma capture procedure. Two-weeks post initial cellular infusion, subject may be eligible to receive additional cellular infusions. If so, either the same or an alternative donor may be considered however, a subject will not receive more than 3 infusions from one donor or exceed 6 infusions in total from all donors. Infusions will be a minimum of 14-days apart. Subjects will not receive additional infusions if they exhibit Graft Versus Host Disease (GvHD) or Cytokine Release Syndrome (CRS) Grade II or higher, according to CTCAE v5. If a subject is to receive a second infusion, eligibility and baseline data collection will not be repeated for the recipient or original donor, unless necessary per institutional guidelines. Should an alternative donor be selected for an infusion, eligibility of the new donor will need confirmed. Pregnant donors may be considered if medically suitable. Two weeks post-initial cellular infusion, the following criteria will be assessed to determine if additional infusions are necessary: * Complete response: Return to normal range as defined by specific assay used and clinical signs and symptoms. These subjects are not eligible to receive an additional cellular infusion. * Partial response: Decrease in viral load of at least 50% from baseline or significant improvement of clinical signs. The clinical response is further defined as meeting one or more of the following criteria and no worsening in any of the others: 1. Absence of fever, if fever is present at baseline 2. No need for pressors, if on pressors at baseline 3. No need for oxygen and/or mechanical ventilation, if needed at baseline 4. Decrease in stool output, if is diarrhea present at baseline These subjects may receive additional cellular infusions as clinically indicated: * Stable disease: Changes insufficient to qualify as partial response or progression. These subjects are eligible to receive additional cellular infusions. * Progression: Increase in viral load of at least 50% from baseline or dissemination to other sites of disease. These subjects are eligible to receive additional cellular infusions. Subjects are followed for six months post initial viral-specific T cell infusion. If a subject receives additional infusions, GVHD and adverse events only will be followed for a minimum of three months from last infusion, even if extending beyond the six-month follow-up from the first infusion. Data may be abstracted from subjects' medical charts for an additional 1 year after most recent viral-specific T cell infusion.
Age
0–65
Sex
ALL
Healthy volunteers
Not accepted
