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

Phase 1

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Autologous memory lymphocyte Injection (NewishT), low-dose group; Drug: Autologous memory lymphocyte Injection (NewishT), high-dose group

• Registration Number: NCT05352646
• Lead Sponsor: Newish Technology (Beijing) Co., Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2022-04-24
• Study First Submitted QC: 2022-04-24
• Study First Posted: 2022-04-29
• Study Start: 2022-07-26
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NewishT	Autologous memory lymphocyte Injection (NewishT), low-dose group	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.
NewishT	Autologous memory lymphocyte Injection (NewishT), high-dose group	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.

Primary Outcome Measures

Name	Time	Method
dose-limiting toxicity (DLT)	14 days after last administration	Any AEs that is definitely, probably, or possibly related to the test drug occurring within 14 days of the last dosing will be classified as DLT during dosing climb.

Secondary Outcome Measures

Name	Time	Method
recurrence-free survival(RFS) rate	1 year	The probability of no recurrence or death within 1 year from the date of radical hepatocellular carcinoma resection.
All adverse events (AE)	1 year	Including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events)

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China