HER2 Targeted HypoSti.CAR-T Cells in HER2 Positive Advanced Solid Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 11, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
HER2 Positive Advanced Solid Tumors
Interventions
BIOLOGICAL

HypoSti.CAR-HER2 T cells

Dose escalation: dose -1 (1×10\^6 cells/kg) ,dose 1 (3×10\^6 cells/kg) , dose 2 (6×10\^6 cells/kg), dose 3 (1×10\^7 cells/kg), dose 4 (1.5×10\^7 cells/kg). Dose expansion: RP2D

DRUG

Albumin-bound paclitaxel

Administered intravenously at dose of 100-200mg/m2 on day -5

DRUG

Cyclophosphamide

Administered intravenously at a total dose of 15-30mg/kg on day -3 and day-2

DRUG

Fludarabine

Administered intravenously at dose of 30mg/m2/d on day -3 and day -2 only in the first infusion of HypoSti.CAR-HER2 T cells

Trial Locations (1)

+86100853

RECRUITING

Kaichao Feng, Beijing

All Listed Sponsors
collaborator

Fudan University

OTHER

lead

Chinese PLA General Hospital

OTHER