NCT05352646

NewishT Cell Therapy for HCC With High Risk of Recurrence After Radical Resection

Autologous Memory Lymphocyte（NewishT）for Hepatocellular Carcinoma With High Risk of Recurrence After Radical Resection

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Newish Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and efficacy of autologous memory lymphocyte therapy (NewishT) in patients with hepatocellular carcinoma at high risk of recurrence after radical resection.

Detailed description

This study is divided into two dose groups and two phases. Phase Ia climbed from low-dose group to high-dose group in turn according to the 3+3 dose escalation principle. Phase Ib extended 10 subjects each group. After the completion of treatment, the subjects shall continue to receive safety follow-up until 14 days after the last administration, and all adverse events shall revert to level I or all adverse events shall be clinically stable (whichever is later achieved); Tumor imaging assessment was performed at week 7 and week 20 to observe the progression of disease. After week 20, the survival follow-up period was entered, and patients were followed up until death, loss of follow-up, or trial termination, whichever occurred first. Survival was followed up by telephone every 12 weeks (±7 days), and radiographic evidence should be obtained if recurrence/progression occurred.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Autologous memory lymphocyte Injection (NewishT), low-dose group	Recruited participants in low-dose group will receive autologous memory lymphocyte (NewishT) intravenous infusion every 4 weeks, a total of 2 times.
DRUG	Autologous memory lymphocyte Injection (NewishT), high-dose group	Recruited participants in high-dose group will receive autologous memory lymphocyte (NewishT) intravenous infusion every 2 weeks, a total of 4 times.

Timeline

• Start date: 2022-07-26
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2022-04-29
• Last updated: 2023-09-28

Locations

1 site across 1 country: China