Advanced Hepatocellular CarcinomaPhase 1/2NCT05628545
Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
A Phase 1/2 study testing GDKM-100 injection in people with Advanced Hepatocellular Carcinoma, run by Guangdong GD Kongming Biotech LLC at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- GDKM-100 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- GDKM-100 injection
- Keywords
- hepatocellular carcinoma, gamma delta T cell, Allogeneic, Adoptive Treatment
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDKM-100 injectionBiological
Participants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| GDKM-100 injection | Experimental | 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). Receives: Biological: GDKM-100 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to approximately 16months
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;)
Measured: up to approximately 16months
Overall Survival
From the date of entry into the clinical study until death from any cause
Measured: Up to 16months
Secondary outcomes (5)
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
Measured: up to approximately 16months
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.
Measured: up to approximately 16months
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
Measured: up to approximately 16months
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.
Measured: up to approximately 16months
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.
Measured: up to approximately 16months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Nov 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Oct 2024 (estimated)
Why it stopped: COVID1-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong GD Kongming Biotech LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jinan University Guangzhou
- Responsible party
- Sponsor
- Investigators
- Zhi nan Yin, PhD.MD., Principal investigator, Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628545
- Sponsor's protocol ID
- GDKM-100-08HEP
- Status last verified
- Jan 2023
- First submitted
- 2 Nov 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
- ClinicalTrials.gov ID
- NCT05628545
- Acronym / sponsor ID
- GDKM-100-08HEP
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, gamma delta T cell, Allogeneic, Adoptive Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID1-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangdong GD Kongming Biotech LLCIndustry (pharma, biotech, devices)
- Collaborators
- Jinan University Guangzhou
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GDKM-100 injection | Experimental | Biological: GDKM-100 injectionIn 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDKM-100 injectionParticipants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks. | Biological | GDKM-100 injection |
Primary outcome
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.
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;)
Overall Survival
Time frame: Up to 16months
From the date of entry into the clinical study until death from any cause
5 secondary outcomes
ORR（objective remission rate ）
Time frame: up to approximately 16months
TTP（time to disease progression )
Time frame: up to approximately 16months
DoR(duration of remission )
Time frame: up to approximately 16months
DCR (disease control rate)
Time frame: up to approximately 16months
PFS（Progression-Free Survival )
Time frame: up to approximately 16months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi nan Yin, PhD.MD. principal investigator
Jinan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GDKM-100 injection in people with Advanced Hepatocellular Carcinoma, run by Guangdong GD Kongming Biotech LLC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of performance status score (time frame: up to approximately 16months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.