Phase 1
N=10
Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03175679 ↗Enrolled (actual)
10
Serious AEs
50.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Adverse Events — 12; 2; 8; 4 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- iNKT cells (Biological); IL-2 (Drug); Tegafur (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beijing YouAn Hospital
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
12; 2; 8; 4; 0; 1 | — |
| SECONDARY Progression-Free Survival (PFS) |
1; 1; 2; 0; 1; 2 | — |
| SECONDARY Number of Participants With Stabilized (SD) or Progressive (PD) Disease. |
3; 3; 3; 1; 0; 0 | — |
| SECONDARY Overall Survival (OS) |
1; 0; 2; 0; 0; 1 | — |
Summary
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).
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03175679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.