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

NCT05352646 | Unknown Phase 1

• 1 other identifier: NewishT-HCC-002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• dose-limiting toxicity (DLT)

  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.

  14 days after last administration

Secondary Outcomes (2)

• All adverse events (AE)

  1 year

• recurrence-free survival(RFS) rate

  1 year

Study Arms (1)

NewishT

EXPERIMENTAL

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.

Drug: Autologous memory lymphocyte Injection (NewishT), low-dose group; Drug: Autologous memory lymphocyte Injection (NewishT), high-dose group

Interventions

Autologous memory lymphocyte Injection (NewishT), low-dose group DRUG

Recruited participants in low-dose group will receive autologous memory lymphocyte (NewishT) intravenous infusion every 4 weeks, a total of 2 times.

Also known as: Low-dose group

NewishT

Autologous memory lymphocyte Injection (NewishT), high-dose group DRUG

Recruited participants in high-dose group will receive autologous memory lymphocyte (NewishT) intravenous infusion every 2 weeks, a total of 4 times.

Also known as: High-dose group

NewishT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ age ≤75, regardless of gender;
• Primary hepatocellular carcinoma, which was diagnosed in one of the following conditions: 1) Hepatocellular carcinoma (HCC) confirmed by histopathology or cytology; 2) Meet the clinical diagnostic criteria of liver cancer in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition);
• HBsAg or HBV DNA positive serological test, active virus infection is willing to accept anti-HBV virus treatment during the study period;
• Barcelona clinic liver cancer (BCLC) stage A/B or Chinese Hepatocellular carcinoma Stage (CNLC) IA-IIIA;
• Underwent radical resection of liver cancer (open surgery, laparoscopic surgery, ablation, robot-assisted surgery) within 12 weeks before blood sampling for the first NewishT preparation; The interval between clinical staging of BCLC or CNLC hepatocellular carcinoma and radical resection was less than 12 weeks.
• No residual intrahepatic tumor was found by imaging examination within 4 weeks before blood sampling for the first NewishT preparation; No lymph node metastasis, no extrahepatic metastasis;
• Patients undergoing radical resection of liver cancer should meet the intraoperative criteria of radical resection of liver cancer:
• (1) There was no invasion of adjacent organs, hilar lymph nodes or distant metastasis during the operation; (2) Negative cutting margin;
• \. No Vp4 macrovascular invasion, hepatic vein or inferior vena cava macrovascular invasion of any grade after radical resection (see Appendix 12 for definition of macrovascular invasion);
• \. Meeting any of the following high recurrence risk factors after radical mastectomy:
• Patients undergoing radical resection:
• Number of tumors ≥3;
• Single tumor patients: patients with tumor diameter ≥ 5cm;
• Single tumor patients: patients with tumor diameter \< 5cm, pathological report showed Microvascular invasion (MVI) or Vp1/Vp2/Vp3 macrovascular invasion;
• Edmondson-Steiner grade Ⅲ or Ⅳ of hepatocellular carcinoma;

You may not qualify if:

• Patients with any of the following were excluded from the study:
• HCC recurred before blood collection for the first NewishT preparation;
• Before blood sampling for the first NewishT preparation, the investigator judged that the patient had not fully recovered from the toxicity and/or complications of radical resection;
• There are contraindications to TACE;
• After radical hepatectomy or during the screening period, received or planned to receive radiotherapy, chemotherapy, molecular targeted therapy, biological therapy, TACE therapy, radiofrequency ablation and other anti-liver cancer therapies (except postoperative TACE adjuvant therapy specified in the protocol);
• accompanied by hepatic encephalopathy;
• Regular renal dialysis is required;
• with uncontrolled pleural effusion, pericardial effusion, or moderate or more ascites (refers to ascites that cannot be easily controlled by diuretic treatment);
• A history of gastrointestinal bleeding, current active bleeding, or bleeding tendency within 28 days before screening;
• had received systemic antitumor therapy (including chemotherapy, molecular targeted therapy, biological immunotherapy) for liver cancer within 28 days before screening;
• had undergone transcatheter arterial interventional therapy (transcatheter arterial chemoembolization \[TACE\], transcatheter arterial chemoembolization \[TAE\], transcatheter arterial infusion chemotherapy \[HAIC\], radioactive microsphere TACE\[TARE\], etc.), radiotherapy, microwave ablation, cryotherapy, high-power ultrasound focused ablation and other local treatments for liver tumors. Radical ablation and resection are excluded;
• Participated in another clinical trial or was under observation in another clinical trial within 28 days prior to screening;
• Continuous (more than 1 week) glucocorticoid therapy (dose equivalent to prednisone \&gt; 10 mg/ day), except hormone replacement therapy and intratracheal administration;
• A history of immune deficiency or autoimmune diseases (e.g., rheumatoid joint disease, systemic lupus erythematosus, multiple sclerosis, etc.);
• A history of allogeneic stem cell/tissue/solid organ transplantation (including bone marrow transplantation);

Sponsors & Collaborators

• Newish Technology (Beijing) Co., Ltd.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Jianqiang Cai

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Defang Liu, Phd

CONTACT

13718744928; ldf@newishes.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: April 29, 2022
• Study Start: July 26, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication
• Access Criteria: by publication

Locations

CN (1)