- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05628545
Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
Clinical Study on Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
Brief Summary: In this study, effects of γδ T cells on Advanced hepatocyte carcinoma The goal of this clinical trial is to learn about effects of allogeneic γδ T therapy in advanced hepatocyte carcinoma patients.
The main question it aims to answer is:Will advanced hepatocyte carcinoma patients be benefit from allogeneic γδ T therapy? Participants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Bing Liu, Doctor
- Phone Number: 00-86-0756-2222569
- Email: bingcooler@163.com
Study Contact Backup
- Name: Zheng Xiang, PhD.MD.
- Phone Number: 00-86-020-31608313
- Email: xiangzh@gdkongming.com
Study Locations
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Guangdong
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Zhuhai, Guangdong, China, 519050
- Zhuhai People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- Age is 18-75 years old, and gender is unlimited;
- HCC was confirmed by pathological or clinical examination;
- Patients with stage CNLCIII, IV primary HCC who are receiving second-line treatment / unable to receive existing treatments, or CNLCI and II of primary HCC patients who are unable to receive existing treatments;
- Male subjects with partner women of childbearing age must have reliable, effective methods of contraception starting from the signing of the informed consent form until 120 days after the last dose of the study drug. Male subjects with a pregnant spouse must use condoms without other contraceptive methods;
- Participants volunteered to join the study, signed an informed consent, had good compliance, and cooperated with the follow-up.
Exclusion criteria
- Gastrointestinal bleeding, refractory ascites, hepatic encephalopathy, or hepatorenal syndrome;
- Accept other cellular or immune clinical experiments within 8 weeks before enrollment;
- Immunological deficiency, a known immunosuppressive disease or HIV;
- Active infection, unexplained fever;
- Serious or unstable heart, lung, kidney and hematopoietic system diseases;
- Autoimmune diseases, such as rheumatoid arthritis;
- Neurological diseases, diffuse leptomeningeal diseases; combined with neurodegenerative diseases;
- Hormone use during cell therapy: dexamethasone dose exceeds 2mg / day during immunotherapy;
- Pregnant or lactating women;
- The subject had a known history of psychotropic substance abuse or drug use; he had stopped drinking Patients can be enrolled; 11 In the judgment of the investigator, the subject has other factors that may cause the forced termination of the study, such as other serious diseases or serious abnormal laboratory examination or other family or social factors that will affect the subject's safety of the subject, or the collection of trial data and samples.
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: GDKM-100 injection
In this trial, the patients will receive multiple high-activity γδ T cell immunotherapies.The trial is divided into two parts: Part 1 is a multiple-dose escalation trial consisting of 3 dose groups (2×10^8 cells/person, 5×10^8 cells/person, 10×10^8 cells/person at 1-3 infusion, 4-6 infusion and 7-9 infusion), with 9 patients planned to be enrolled. Part 2 is a single dose trial in which doctor and the PI evaluates whether to give the rest patients to receive the 10×10^8 cells/person infusions based on available safety data. The check indexes are CT scan,intestinal flora detection and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
Participants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of performance status score
Time Frame: up to approximately 16months
|
In medicine(oncology and Other fields), performance status is an attempt to Quantify cancer patients' general well-being and activities of daily life.This measure is used to determine whether they can receive chemotherapy, whether dose adjustment is necessary,and as a measure for the required intensity of palliative care. It is also used in oncological randomized controlled trials as a measure of quality of life. PS scores range from 1 to 5,with Higher PS score indicating worse prognosis. |
up to approximately 16months
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The Child-Pugh score
Time Frame: up to approximately 16months
|
The Child-Pugh score is a system for assessing the prognosis-including the required strength of treatment and necessity of liver transplant-of chronic liver disease.
It provides a forecast of the increasing severity of liver disease and expected survival rate.Child-Pugh scores range from 5 to 15, with higher scores indicating worse prognosis.Class A: 5-6, Class B: 7-9, Class C: 10-15 (minimum 5, maximum 15;)
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up to approximately 16months
|
Overall Survival
Time Frame: Up to 16months
|
From the date of entry into the clinical study until death from any cause
|
Up to 16months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR(objective remission rate )
Time Frame: up to approximately 16months
|
ORR is defined as the percentage of participants in the analysis population who have a Complete Responseor a Partial Response . CR: Disappearance of all target lesions PR: at least 30% decrease in the sum of diameters of target lesions |
up to approximately 16months
|
TTP(time to disease progression )
Time Frame: up to approximately 16months
|
Time to progression is defined as the time from study enrollment until radiological progression in a previously embolized lobe, development of new lesions in an untreated lobe, or evidence of extrahepatic progression .Patients that die of causes unrelated to the study drug without evidence of progression will be censored.
Participants without progression at the time of analysis were censored at their last date of tumor evaluation.
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up to approximately 16months
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DoR(duration of remission )
Time Frame: up to approximately 16months
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The duration of response (DoR) is measured from the time the criteria are met for CR or PR (whichever is first recorded) until the date that recurrent or progressive disease is documented. CR: Disappearance of all target lesions PR: at least 30% decrease in the sum of diameters of target lesions |
up to approximately 16months
|
DCR (disease control rate)
Time Frame: up to approximately 16months
|
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD. CR(complete response):Disappearance of all target lesions PR( partial response):at least 30% decrease in the sum of diameters of target lesions SD(stable disease):any cases that do not qualify for either partial response or progressive disease. |
up to approximately 16months
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PFS(Progression-Free Survival )
Time Frame: up to approximately 16months
|
Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of objective disease progression or death from any cause without evidence of disease progression, whichever comes first.
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up to approximately 16months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Zhi nan Yin, PhD.MD., Jinan University
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
- GDKM-100-08HEP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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