TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 10, 2017

Primary Completion Date

May 30, 2019

Study Completion Date

August 23, 2024

Conditions
Breast Cancer
Interventions
BIOLOGICAL

TAA-specific CTLs

"Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc.~Dose schedule:~Day 0: 2 x 10\^7 cells/m2~Day 28: 2 x 10\^7 cells/m2~If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion."

Trial Locations (2)

77030

Houston Methodist Hospital, Houston

77054

Smith Clinic - Harris Health System, Houston

All Listed Sponsors
collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Cancer Prevention Research Institute of Texas

OTHER

lead

Baylor College of Medicine

OTHER

NCT03093350 - TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer | Biotech Hunter | Biotech Hunter