- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040438
Natural Killer (NK) Cell Therapy in Locally Advanced HCC
A Phase 2a Study Using Natural Killer (NK) Cell Therapy Combined With Hepatic Artery Infusion Chemotherapy (HAIC) in Patients With Locally Advanced Hepatocellular Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective I. To assess the objective response rate (ORR) of administering VAX-NK/HCC, autologous NK cells combined with HAIC in patients with locally advanced HCC.
Secondary Objectives I. To assess the efficacy of administering VAX-NK/HCC combined with HAIC. II. To assess the safety of administering VAX-NK/HCC combined with HAIC. III. To assess the immune responses of administering VAX-NK/HCC combined with HAIC.
OUTLINE: This is a Phase 2a study. Patients receive HAIC treatment every 4 week for up to 4 cycles followed by ex-vivo expanded autologous NK cell infusions. The NK cell treatment repeats every 4 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients will be followed until the disease progression.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Seon-Ah Ha, Ph.D.
- Phone Number: +82-61-375-8863
- Email: seonah387@vaxcell-bio.com
Study Locations
-
-
Jeollanam-do
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Hwasun, Jeollanam-do, Korea, Republic of, 58141
- Recruiting
- Seon-Ah Ha
-
Contact:
- Seon-Ah Ha, Ph.D.
- Phone Number: +82613758863
- Email: seonah387@vaxcell-bio.com
-
Contact:
- Deok ha Kim, M.S.
- Phone Number: +82613758863
- Email: dh.kim@vaxcell-bio.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects with intermediate and/or locally advanced HCC histologically confirmed by biopsy or by typical radiological findings.
- Subjects who were not suitable for or failed curative treatments such as surgical resection, local ablation therapy, transarterial chemoembolization (TACE), sorafenib, atezolizumab, bevacizumab, etc.
- Child-Pugh liver function class A or B.
- Subjects' ECOG performance status of 0 or 1.
- The presence of macrovascular invasion.
- Adequate liver, renal, and hematologic functions.
Exclusion Criteria:
- Subjects who received the immune cell-based therapy within 6 months before the screening visit.
- Subjects with a history of a malignancy other than HCC within the last 5 years, liver transplantation, and hypersensitivity to 5-FU or cisplatin.
- Subjects with extra-hepatic metastases.
- Subjects who have ongoing autoimmune disease.
- Female subjects who are pregnant or lactating or women of child-bearing potential but unable to take adequate contraception.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Autologous NK cell infusion combined with HAIC
HAIC of 5-FU (500 mg/m2, Q4W) and cisplatin (15 mg/m2, Q4W) will be administered for up to 4 cycles to patients with locally advanced HCC.
Subjects who achieved sustained SD or better based on the mRECIST criteria after 2nd cycle of HAIC will be enrolled to receive 1x10^9 cells VAX-NK/HCC infusion.
|
autologous NK cells expanded ex vivo.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR) of administering VAX-NK/HCC combined with HAIC
Time Frame: average 6 months
|
ORR will be measured as the proportion of patients with a best overall response of complete response (CR) and partial response (PR) of administering VAX-NK/HCC combined with HAIC.
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average 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR) of administering VAX-NK/HCC combined with HAIC
Time Frame: average 6 months
|
ORR will be measured as the proportion of patients with a best overall response of complete response (CR), partial response (PR), and stable disease (SD) of administering VAX-NK/HCC combined with HAIC.
|
average 6 months
|
Time to progression (TTP) of administering VAX-NK/HCC combined with HAIC
Time Frame: average 6 months
|
TTP will be measured by time to progression, defined as time from enrollment to disease progression.
|
average 6 months
|
Overall survival (OS) of administering VAX-NK/HCC combined with HAIC
Time Frame: average 12 months
|
OS will be measured as time from enrollment to death due to any cause.
|
average 12 months
|
Quality of Life of administering VAX-NK/HCC combined with HAIC
Time Frame: average 6 months
|
The assessment will be performed using the Korean versions of European Organization for Research and Treatment of Cancer (EORTC) Questionnaire 30 (QLQ-C30) consisting of 30 items.
Total score: Range 0-100.
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average 6 months
|
Adverse Events (AEs) and Serious Adverse Events (SAEs) of administering VAX-NK/HCC combined with HAIC
Time Frame: average 6 months
|
The assessment will be measured by determining the number of patients that experience AEs and SAEs graded according to the NCI-CTCAE (Version 4.0)
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average 6 months
|
The proportions of T and NK cells
Time Frame: average 6 months
|
This will be measured by determining the relative percentages of CD4+CD8+ T cells and CD3- CD56+ NK cells in patients' peripheral blood.
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average 6 months
|
The lymphocyte/monocyte ratio (LMR)
Time Frame: average 6 months
|
LMR will be calculated by dividing the absolute lymphocyte count by the absolute monocyte count in patients' peripheral blood.
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average 6 months
|
The NK cell cytotoxicity
Time Frame: average 6 months
|
This will be measured by determining percent cell lysis of target cells (K562) in patients' peripheral blood.
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average 6 months
|
The serum cytokine levels
Time Frame: average 6 months
|
The serum concentrations of IFN-γ, IL-10, and TGF-β will be measured in patients' serum using the Enzyme-Linked immunosorbent assays.
|
average 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Seon-Ah Ha, Ph.D., VaxCell Biotherapeutics Co., Ltd.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vax-NK/HCC-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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