Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
- Conditions
- Advanced Hepatocellular Carcinoma
- Interventions
- Biological: GDKM-100 injection
- Registration Number
- NCT05628545
- Lead Sponsor
- Guangdong GD Kongming Biotech LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GDKM-100 injection 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).
- Primary Outcome Measures
Name Time Method The change of performance status score 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.Overall Survival Up to 16months From the date of entry into the clinical study until death from any cause
The Child-Pugh score 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;)
- Secondary Outcome Measures
Name Time Method PFS（Progression-Free Survival ) 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.
TTP（time to disease progression ) 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.
DoR(duration of remission ) up to approximately 16months 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 lesionsORR（objective remission rate ） 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 lesionsDCR (disease control rate) 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.
Trial Locations
- Locations (1)
Zhuhai People'S Hospital
🇨🇳Zhuhai, Guangdong, China