NCT05277987

An Evaluation Trial About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects

A Single Arm, Open Lable and Single Site Early Phase I Clinical Trial to Evaluate the Safety, Cell Kinetics and Initial Efficacy About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shenzhen Fifth People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

An Evaluation Trial About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects. To evaluate the tolerability and safety of different doses of HEC-016 CAR-T cell injections in patients with advanced gastric / esophagogastric junction adenocarcinoma and pancreatic cancer, to observe dose limiting toxicity (DLT), to determine the maximum tolerated dose (MTD) and to recommend the regimen for subsequent clinical trials.

Detailed description

Single Site, single arm and open label design are adopted. The dose increment is based on the traditional "3 + 3" method, and the initial dose is set to 0.5 × 10\^6 car-t cells / kg, and 3 \~ 6 subjects are expected to be included in each dose group. DLT was observed within 28 days after infusion. One suject of each dose group was enrolled first, and there was no DLT within 14 days before entering the next subject. If the subject had DLT within 14 days, the investigator can evaluate whether the dose group continued to be enrolled and the time interval of the next subject. After completing the safety observation of 3 subjects who meet the DLT evaluation and analysis set in each dose group, they can be increased to the next dose when there is no DLT; If one subject in the first three cases has DLT, another three subjects need to be selected into the dose group (but the researcher can also decide whether to continue to be selected into the dose group according to the actual situation of the subjects). In the process of dose increase, if DLT occurs in ≥ 2 / 3 or ≥ 2 / 6 subjects in a dose group, the dose increase stops.

Conditions

• CAR T-Cell Therapy

Interventions

Type	Name	Description
DRUG	HEC-016(0.5×10^6 CAR-T Cells)	The initial dose is set to 0.5 × 10\^6 car-t cells / kg, and 3 \~ 6 subjects are expected to be included in the dose group. DLT was observed within 28 days after cell infusion.
DRUG	HEC-016(0.5×10^6.5 CAR-T Cells)	The Second dose is set 0.5 × 10\^6.5 car-t cells / kg, and 3 \~ 6 subjects are expected to be included in the dose group.
DRUG	HEC-016(0.5×10^7 CAR-T Cells)	The Third dose is set 0.5 × 10\^7 car-t cells / kg, and 3 \~ 6 subjects are expected to be included in the dose group.

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2022-03-14
• Last updated: 2022-03-14

Locations

1 site across 1 country: China