Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 29, 2025

Primary Completion Date

December 10, 2027

Study Completion Date

December 28, 2028

Conditions
SarcomaSarcoma, KaposiSarcoma, EwingSarcoma,Soft TissueSarcoma of Bone and Connective TissueSarcoma, SynovialSarcoma MetastaticSarcomas, GerminoblasticSarcoma of Bone
Interventions
BIOLOGICAL

CD146/HER2 CAR-T cells

"The intervention in this clinical trial involves a novel approach using CD146/HER2 Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies.~Treatment Regimen:~Patients in the trial will undergo the following regimen:~Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy.~Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2.~BCMA/GPRC5D Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD146/HER-2 CAR T cells, over 10-20 minutes on day 0.~Additional Doses: Eligible patients responding well to the initial CD146/HER-2 CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses."

Trial Locations (1)

086-373

RECRUITING

District One Hospital, Beijing

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Essen Biotech

OTHER