Back to resultsAdoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
Primary Purpose
Advanced Hepatocellular Carcinoma
Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GDKM-100 injection
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, gamma delta T cell, Allogeneic, Adoptive Treatment
Eligibility Criteria
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.
Sites / Locations
- Zhuhai People'S Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GDKM-100 injection
Arm Description
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).
Outcomes
Primary Outcome Measures
The change of performance status score
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.
The Child-Pugh score
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;)
Overall Survival
From the date of entry into the clinical study until death from any cause
Secondary Outcome Measures
ORR（objective remission rate ）
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
TTP（time to disease progression )
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.
DoR(duration of remission )
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
DCR (disease control rate)
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.
PFS（Progression-Free Survival )
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.
Full Information
NCT ID
NCT05628545
First Posted
November 2, 2022
Last Updated
January 16, 2023
Sponsor
Guangdong GD Kongming Biotech LLC
Collaborators
Jinan University Guangzhou
1. Study Identification
Unique Protocol Identification Number
NCT05628545
Brief Title
Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
Official Title
Clinical Study on Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
COVID1-19 pandemic
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong GD Kongming Biotech LLC
Collaborators
Jinan University Guangzhou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, gamma delta T cell, Allogeneic, Adoptive Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GDKM-100 injection
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
GDKM-100 injection
Intervention Description
Participants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks.
Primary Outcome Measure Information:
Title
The change of performance status score
Description
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.
Time Frame
up to approximately 16months
Title
The Child-Pugh score
Description
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;)
Time Frame
up to approximately 16months
Title
Overall Survival
Description
From the date of entry into the clinical study until death from any cause
Time Frame
Up to 16months
Secondary Outcome Measure Information:
Title
ORR（objective remission rate ）
Description
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
Time Frame
up to approximately 16months
Title
TTP（time to disease progression )
Description
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.
Time Frame
up to approximately 16months
Title
DoR(duration of remission )
Description
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
Time Frame
up to approximately 16months
Title
DCR (disease control rate)
Description
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.
Time Frame
up to approximately 16months
Title
PFS（Progression-Free Survival )
Description
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.
Time Frame
up to approximately 16months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi nan Yin, PhD.MD.
Organizational Affiliation
Jinan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhuhai People'S Hospital
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519050
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
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