NCT06572956

Clinical Study on the Safety and Efficacy of CAR-T/CAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Second Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc

Detailed description

To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc. The study was divided into five stages: screening period, single harvest period, pretreatment chemotherapy period, treatment period, observation and follow-up period after treatment. Subjects were pretreated with FC regimen before transfusion, and the subjects who met the infusion conditions were given CAR-T/CAR-NK cell infusion 1 \~ 2 days after the completion of eluent chemotherapy. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion. The efficacy was evaluated according to the evaluation criteria for solid tumors (RECIST1.1 selection).

Conditions

• Safety and Efficacy of Cellular Drugs, Objective Response Rate of Subjects, Etc

Interventions

Type	Name	Description
BIOLOGICAL	CAR-T/CAR-NK cell injection	One to two days after completion of eluvial chemotherapy, CAR-T/CAR-NK cells were transfused in subjects assessed by the investigators as eligible for infusion. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion.

Timeline

• Start date: 2024-03-21
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-08-27
• Last updated: 2024-08-27

Locations

1 site across 1 country: China