ARMS - Rapidly Generated Multivirus-Specific CTLs for Prophylaxis & Treatment of EBV, CMV, Adenovirus, HHV6 & BK Virus

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

August 31, 2016

Study Completion Date

September 30, 2017

Conditions
Viral Infection
Interventions
BIOLOGICAL

Multivirus-specific T cells Dose Level 1

"The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level.~Dose Level One: 5x10\^6 mCTLs/m2~There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL."

BIOLOGICAL

Multivirus-specific T cells Dose Level 2

"The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level.~Dose Level Two: 1x10\^7 mCTLs/m2~There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL"

BIOLOGICAL

Multivirus-specific T cells Dose Level 3

"The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level.~Dose Level Three: 2x10\^7 mCTLs/m2~There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL"

Trial Locations (2)

77030

Houston Methodist Hospital, Houston

Texas Children's Hospital, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Baylor College of Medicine

OTHER

collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

lead

AlloVir

INDUSTRY

NCT01570283 - ARMS - Rapidly Generated Multivirus-Specific CTLs for Prophylaxis & Treatment of EBV, CMV, Adenovirus, HHV6 & BK Virus | Biotech Hunter | Biotech Hunter