HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 7, 2021

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2040

Conditions
SarcomaHER-2 Protein OverexpressionOsteosarcomaRhabdomyosarcomaEwing SarcomaSynovial SarcomaSoft Tissue SarcomaUndifferentiated Sarcoma
Interventions
GENETIC

T cells or CAR T cells

"There are 2 dose levels:~Dose Level 1 (1x10\^8 cells/m2) and Dose Level -1 (5x10\^7 cells/m2). In the event that Dose Level 1 is not tolerable, de-escalation to Dose Level -1 will occur."

DRUG

Pembrolizumab Injectable Product

2 mg/kg/dose (max 200 mg/dose) every 3 weeks

DRUG

Nivolumab Injectable Product

3 mg/kg/dose (\<40kg) or 124 mg (≥40 kg) every 2 weeks

Trial Locations (1)

77030

RECRUITING

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

collaborator

The Faris Foundation USA

UNKNOWN

collaborator

Stand Up To Cancer

OTHER

collaborator

Triumph Over Kid Cancer Foundation

UNKNOWN

collaborator

St. Baldrick's Foundation

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

Baylor College of Medicine

OTHER