Hepatic Artery Transfusion of NKG2D CAR-NK Cells Followed by Intravenous Infusion of NKG2D CAR-T Cells to Treat Patients With Advanced Solid Tumors With Liver Metastases Who Have Failed Standard Treatments: a Phase I Exploratory Clinical Trial

PHASE1RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 10, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Patients With Advanced Solid Tumors With Liver Metastases Who Have Failed Standard Treatments
Interventions
BIOLOGICAL

NKG2D CAR NK and NKG2D CAR T cells

"* NKG2D CAR-NK cells (hepatic artery infusion, D0 dose: 1×10⁹ cells,D1 dose: 1×10⁹ cells)~* NKG2D CAR-T cells (Over a two-day period, CAR-T cells are administered via intravenous infusion on two consecutive occasions.In the initial phase, rapid titration dose escalation was performed with 1 case per group.The initial dose is set at 1.5×10⁷/kg. If grade 2 or higher cytokine release syndrome (CRS) or related adverse events (AEs) occur, the 3+3 dose escalation protocol will be initiated. If not, the starting dose for escalation will be set at 3×10⁷/kg per administration of-T CAR cells, with subsequent escalations to 5×10⁷/kg per administration and 7×10⁷/kg per administration.)~Chemotherapy:~If you are treated with autologous CAR-NK cells, lymphodepleting chemotherapy with FC is usually not required. If you are treated with allogeneic NKG2D CAR-NK cells derived from umbilical cord blood of a healthy donor, the researchers will adjust the FC chemotherapy dosage or choose another appropriate"

Trial Locations (1)

Unknown

RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

Sponsors
All Listed Sponsors
collaborator

CNK Cell Therapeutics Co., Ltd.

UNKNOWN

lead

Zhejiang University

OTHER

NCT07021534 - Hepatic Artery Transfusion of NKG2D CAR-NK Cells Followed by Intravenous Infusion of NKG2D CAR-T Cells to Treat Patients With Advanced Solid Tumors With Liver Metastases Who Have Failed Standard Treatments: a Phase I Exploratory Clinical Trial | Biotech Hunter | Biotech Hunter