Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

December 31, 2024

Study Completion Date

June 30, 2025

Conditions
Viral InfectionPrimary Immune Deficiency Disorder
Interventions
BIOLOGICAL

BK CTL

"Patient with refractory BK infection and a HLA Matched Related Donors: BK specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 12.5 x 104 CD3/kg).~Patients with refractory BK virus and a HLA Mismatched Related Donors: BK specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg)."

Trial Locations (8)

10595

RECRUITING

New York Medical College, Valhalla

19104

RECRUITING

Children's Hospital of Pennsylvania, Philadelphia

21287

RECRUITING

Johns Hopkins, Baltimore

43205

RECRUITING

Nationwide Children's Hosptial, Columbus

53226

RECRUITING

Medical College of Wisconsin, Milwaukee

63130

RECRUITING

Washington University, St Louis

80045

RECRUITING

Children's Hospital of Colorado, Aurora

94158

RECRUITING

University of California San Francisco, San Francisco

Sponsors
All Listed Sponsors
collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

Medical College of Wisconsin

OTHER

collaborator

Nationwide Children's Hospital

OTHER

collaborator

Johns Hopkins University

OTHER

collaborator

University of California, San Francisco

OTHER

lead

New York Medical College

OTHER

NCT04197596 - Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) | Biotech Hunter | Biotech Hunter