Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses special immune system cells called iNKT cells, a new experimental treatment.

The purpose of this study is to find the biggest dose of iNKT cells that is safe and tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to learn the side effects are and to see if the iNKT cells will help people with relapsed/advanced hepatocellular carcinoma (HCC).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC

NCT04011033

Hepatocellular Carcinoma

COMPLETED PHASE2

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

NCT05962450

Hepatocellular Carcinoma

RECRUITING PHASE2

By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy

NCT02725996

Hepatocellular Carcinoma

UNKNOWN PHASE2

Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma

NCT06463522

Hepatocellular Carcinoma

RECRUITING PHASE1/PHASE2

Hepatic Artery Transfusion of NKG2D CAR-NK Cells Followed by Intravenous Infusion of NKG2D CAR-T Cells to Treat Patients With Advanced Solid Tumors With Liver Metastases Who Have Failed Standard Treatments: a Phase I Exploratory Clinical Trial

NCT07021534

Patients With Advanced Solid Tumors With Liver Metastases Who Have Failed Standard Treatments

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PBMCs of enrolled patients were collected and then further separated by density gradient centrifugation. After washing three times, the cells were resuspended in serum-free medium with recombinant human IL-2 and α-GalCer. Restimulation with α-GalCer-pulsed autologous DCs was done on days 7. After 14 days of cultivation, the iNKT cells were harvested, washed thrice, and then resuspended in saline. The frequency of iNKT cells before and after cultured in vitro were determined by flow cytometry analysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Four planned loading dose of iNKT cells for 10 patients.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

iNKT cell loading dose:3x10^7/m2

Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.

iNKT Cell Loading Dose：3x10\^7/m2.

IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

Group Type EXPERIMENTAL

iNKT cells

Intervention Type BIOLOGICAL

The patients received different doses of in vitro-expanded autologous iNKT cells through intravenous infusion. The dosage was escalated from 3x10\^7 cells/m2 to 6x10\^7 cells/m2 to 9x10\^7 cells/m2. The maximum tolerated dose (MTD) was defined as the last dose level, and the dosage would be up to 1x10\^10 cells/m2 if no MTD was observed after a 3+3 design.

IL-2

Intervention Type DRUG

IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

Tegafur

Intervention Type DRUG

Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

iNKT cell loading dose:6x10^7/m2

Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.

iNKT Cell Loading Dose：6x10\^7/m2.

IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

Group Type EXPERIMENTAL

iNKT cells

Intervention Type BIOLOGICAL

The patients received different doses of in vitro-expanded autologous iNKT cells through intravenous infusion. The dosage was escalated from 3x10\^7 cells/m2 to 6x10\^7 cells/m2 to 9x10\^7 cells/m2. The maximum tolerated dose (MTD) was defined as the last dose level, and the dosage would be up to 1x10\^10 cells/m2 if no MTD was observed after a 3+3 design.

IL-2

Intervention Type DRUG

IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

Tegafur

Intervention Type DRUG

Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

iNKT cell loading dose:9x10^7/m2

Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.

iNKT Cell Loading Dose：9x10\^7/m2.

IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

Group Type EXPERIMENTAL

iNKT cells

Intervention Type BIOLOGICAL

The patients received different doses of in vitro-expanded autologous iNKT cells through intravenous infusion. The dosage was escalated from 3x10\^7 cells/m2 to 6x10\^7 cells/m2 to 9x10\^7 cells/m2. The maximum tolerated dose (MTD) was defined as the last dose level, and the dosage would be up to 1x10\^10 cells/m2 if no MTD was observed after a 3+3 design.

IL-2

Intervention Type DRUG

IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

Tegafur

Intervention Type DRUG

Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

iNKT cell loading dose:1x10^10/m2

Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.

iNKT Cell Loading Dose：1x10\^10/m2.

IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

Group Type EXPERIMENTAL

iNKT cells

Intervention Type BIOLOGICAL

The patients received different doses of in vitro-expanded autologous iNKT cells through intravenous infusion. The dosage was escalated from 3x10\^7 cells/m2 to 6x10\^7 cells/m2 to 9x10\^7 cells/m2. The maximum tolerated dose (MTD) was defined as the last dose level, and the dosage would be up to 1x10\^10 cells/m2 if no MTD was observed after a 3+3 design.

IL-2

Intervention Type DRUG

IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

Tegafur

Intervention Type DRUG

Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iNKT cells

The patients received different doses of in vitro-expanded autologous iNKT cells through intravenous infusion. The dosage was escalated from 3x10\^7 cells/m2 to 6x10\^7 cells/m2 to 9x10\^7 cells/m2. The maximum tolerated dose (MTD) was defined as the last dose level, and the dosage would be up to 1x10\^10 cells/m2 if no MTD was observed after a 3+3 design.

Intervention Type BIOLOGICAL

IL-2

IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

Intervention Type DRUG

Tegafur

Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Human recombinated Interleukin-2 Gimeracil and Oteracil Potassium Capsules

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-80 years.
* Patients with hepatocellular carcinoma (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, relapsed after previous therapy and no effective therapies known at this time.
* Life expectancy of ≥ 12 weeks.
* WBC\>3.5×10\^9/L, LYMPH\> 0.8×10\^9/L, Hb\>85g/L, PLT\>50×10\^9/L, Cre\<1.5×the upper limit of normal value.
* iNKT\>10/mL in peripheral blood mononuclear cell (PBMC).
* Able to understand and sign the informed consent.

Exclusion Criteria

* Any uncontrolled systematic disease: hypertension, heart disease, and et al.;
* Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;
* Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;
* Unstable immune systematic diseases or infectious diseases;
* Combined with AIDS or syphilis;
* Patients with history of stem cell or organ transplantation;
* Patients with allergic history to related drugs and immunotherapy;
* Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;
* Pregnant or lactating subjects;
* Unsuitable subjects considered by clinicians.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No