Neoplasms

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Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

Immunomodulating Agents

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.

GDKM-100 injection

Zhi nan Yin, PhD.MD.

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.

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

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 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;)

From the date of entry into the clinical study until death from any cause

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 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.

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 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.

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.

Jinan University Guangzhou

Guangdong GD Kongming Biotech LLC

autologous cellular therapy comprised predominantly of NK, NK-T, and T cells stored in cryogenic media

PBMC-derived autologous cellular therapy derived through an ex vivo activation procedure, resulting in a cell mixture comprised predominantly of NK, NK-T, and T cells stored in cryogenic media.

SUPLEXA

Rohit Joshi, MD

This Phase 1, first-in-human (FIH), open-label study is designed to assess the safety, tolerability, and preliminary clinical efficacy of repeated intravenous (IV) infusions of SUPLEXA monotherapy in subjects with measurable metastatic solid tumours and haematologic malignancies

This is a FIH Phase 1, non-comparative, open-label, basket-design study. The study will consist of 2 cohorts:

* Solid tumours cohort
* Haematologic malignancies cohort:

Subjects must fulfill entry criteria and have relapsed or refractory advanced malignancy for which no standard therapy exists.

An Data Safety Monitoring Committee (DSMB) will provide oversight of the study and will monitor safety on a regular basis throughout the study to make recommendations on any modifications.

The study will be comprised of 3 periods. Screening, Treatment and Follow-up.

All eligible subjects will receive minimally 3 weekly dosing of SUPLEXA. Subjects will be monitored closely at the clinic after each weekly infusion.

After completion of the first 3 weekly SUPLEXA the treatment period of SUPLEXA may be extended to every 2 weeks until all SUPLEXA is depleted.

non-comparative, open-label, basket-design study

Study of SUPLEXA in Patients With Metastatic Solid Tumours and Haematologic Malignancies

A Phase 1, First-in-Human, Open-label Single Agent Study of SUPLEXA Therapeutic Cells in Patients With Metastatic Solid Tumours and Haematologic Malignancies

Incidence of dose limiting toxicities measured by Incidence of adverse events and serious adverse events overall, by severity, by relationship to each study intervention, and those that led to discontinuation of study intervention.

Objective response rate defined as the proportion of subjects with best overall response of either a complete response or partial response measured by Time to Progression (TTP)

Objective response rate as defined by standard of care.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells	NCT05628545	Advanced Hepato...	GDKM-100 inject...	18 Years - 75 Years	Guangdong GD Kongming Biotech LLC
Study of SUPLEXA in Patients With Metastatic Solid Tumours and Haematologic Malignancies	NCT05237206	Oncology	SUPLEXA	18 Years -	Alloplex Biotherapeutics Inc

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