Clinical trial · Interventional
Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC
A Study of Adoptive Invariant Nature Killer T Cell Therapy for Relapsed/Advanced Hepatocellular Carcinoma (HCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IL-2 | Drug | — | UNRESOLVED |
| iNKT cells | Biological | — | UNRESOLVED |
| Tegafur | Drug | Tegafur | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- iNKT cell loading dose:3x10^7/m2
- description
- 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.
- interventionNames
- Biological: iNKT cells
- Drug: IL-2
- Drug: Tegafur
- type
- EXPERIMENTAL
- label
- iNKT cell loading dose:6x10^7/m2
- description
- 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.
- interventionNames
- Biological: iNKT cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available