Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy

NCT05962450 | Unknown Phase 2 DMC

• 1 other identifier: Beijing YouAn Ethics [2023]060
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the efficacy and safety of autologous iNKT cells in patients with progressed hepatocellular carcinoma (HCC) after treatment with PD-1 antibody. The main question it aims to answer are:

• the efficacy of autologous iNKT cells in patients with progressed HCC after treatment with PD-1 antibody.
• the safety of autologous iNKT cells in patients with progressed HCC after treatment with PD-1 antibody. Participants will be randomized 1:1 to receive Regorafenib + PD-1 + iNKT cells (RPI group) or the treatment of Regorafenib + PD-1 (RP group). Researchers will compare RPI group and RP group to see whether the iNKT cells can achieve a better therapeutic effect on HCC patients with PD-1 resistance.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  The time from enrollment to disease progression according to the modified RECIST (mRECIST) guideline in trial immunotherapeutics, or death from any cause, whichever occurred first；the time from enrollment to confirmed disease progression (iCPD) according to the iRECIST

  The time from enrollment to disease progression, or death from any cause, whichever occurred first, up to 24 months.

Secondary Outcomes (7)

• Disease control rate (DCR)

  Evaluation was performed every 8 weeks after the start of the treatment, up to 24 months.

• Objective response rate (ORR)

  Evaluation was performed every 8 weeks after the start of the treatment, up to 24 months.

• Overall survival (OS)

  Time from the date of enrollment to the date of death from any cause, up to 36 months.

• 1-year overall survival rate (1-year OS rate)

  Time from the date of enrollment to 1 year later.

• Duration of Overall Response (DOR)

  Time from the first tumor remission to the first recording of disease progression or death from any cause, up to 24 months..

Study Arms (2)

RPI group

EXPERIMENTAL

Regorafenib + PD-1 + iNKT cells

Biological: iNKT Cells; Drug: PD-1; Drug: Regorafenib

RP group

OTHER

Regorafenib + PD-1

Drug: PD-1; Drug: Regorafenib

Interventions

iNKT Cells BIOLOGICAL

the iNKT cells will be intravenous infused every two weeks as a course of treatment for up to six courses , the reinfusion dose is determined according to the patient's body surface area, which was about 108\~109cells/m2.

Also known as: Vα24+ T Cells

RPI group

PD-1 DRUG

Intravenous infusion, according to the drug instructions.

RP group; RPI group

Regorafenib DRUG

Oral administration, according to the drug instructions.

RP group; RPI group

Eligibility Criteria

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

You may qualify if:

• years of age.
• Barcelona Clinic Liver Cancer（BCLC） C stage hepatocellular carcinoma (HCC) confirmed by CT, MRI, and/or histopathology.
• Progressed after receiving anti-angiogenic targeted drugs combined with PD-1 monoclonal antibody.
• Life expectancy of at least 12 weeks.
• Child-Pugh A/B.
• Voluntary signing of informed consent.

You may not qualify if:

• History of severe hypertension or cardiac disease.
• known central nervous system (CNS) tumor or combined with other malignant disorders.
• Uncontrolled immune system or infectious disease.
• Known history of the human immunodeficiency virus (HIV) or syphilis infection.
• History of stem cell transplant or organ allograft.
• History of allergy to immunotherapy or related drugs.
• Bilirubin is twice times the upper limit of normal.
• Glomerular filtration rate （GFR）\< 60ml/min.
• Serious complications include moderate or severe infective pleural and peritoneal effusion, pericardial effusion, upper gastrointestinal bleeding, hepatic encephalopathy.
• Pregnancy or lactation.
• History of severe allergy to any monoclonal antibody or anti-angiogenic targeted drug.
• Deemed not suitable for cellular immunotherapy by the investigators.

Sponsors & Collaborators

• Beijing YouAn Hospital: lead
• Beijing Gene Key Life Technology Co., Ltd: collaborator

Study Sites (1)

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

regorafenib

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

Study Officials

• Jun Lu, MD.

  Beijing YouAn Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Lu, MD.

CONTACT

86-13661381489; lujun98@ccmu.edu.cn

Songtao Liu, MD.

CONTACT

86-13811120755; botao8080@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Block randomization was performed by the independent masked statistician. Two independent masked radiologist who are blinded to patients' clinical information will review the imaging examinations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 27, 2023
• Study Start: October 26, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)