Primary Transplant Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

July 13, 2012

Primary Completion Date

December 11, 2019

Study Completion Date

December 11, 2019

Conditions
Cytomegalovirus
Interventions
BIOLOGICAL

CMV-pp65 CTLs

Patients will be treated with CMVpp65-CTLs derived from their transplant donor. These will be patients with CMV seropositive transplant donors who have previously provided leukocytes for generation of CMVpp65-CTL and for whom such CMVpp65-CTL are available. The T-cells to be infused will be selected based on criteria mentioned in section 4.0 from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 106 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.

Trial Locations (1)

10065-0009

Memorial Sloan Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Atara Biotherapeutics

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01646645 - Primary Transplant Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation | Biotech Hunter | Biotech Hunter