Early Phase I Study of Autologous T Cells (EX02 CAR-T) for Unresectable Pancreatic/Bile Duct Cancer

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 30, 2026

Study Completion Date

December 31, 2027

Conditions
Pancreatic CancerAdvanced Biliary Cancer
Interventions
DRUG

anti-EX02 CAR T cells

"Conditioning chemotherapy:~• Lymphodepletion regimen consisting of fludarabine 25 mg/m2/day and cyclophosphamide 250 mg/m2/day for 3 consecutive days, administered 48 hours before first administration of first time of intravenous or intraperitoneal infusion~Investigational Product:~• Regional administration: Acetaminophen 500mg orally and diphenhydramine 20mg intramuscularly (or other non-steroidal anti-inflammatory drugs and antihistamines) were given in advance on the day of administration (day 0). Intraperitoneal infusion or intra-tumoral injection of anti-EX02 CAR T cells, with dosage and method determined by the investigator~• Intravenous administration: Single infusion of CAR-transduced autologous T cells administered intravenously at a target dose of 2 x 106 anti-EX02 CAR T cells/kg, 30 minutes after premedication with oral acetaminophen 500mg and intramuscular diphenhydramine 20mg"

All Listed Sponsors
collaborator

Zeno Therapeutics Pte. Ltd

UNKNOWN

lead

Zhang Xiaofeng,MD

OTHER

NCT06196658 - Early Phase I Study of Autologous T Cells (EX02 CAR-T) for Unresectable Pancreatic/Bile Duct Cancer | Biotech Hunter | Biotech Hunter