Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells

NCT05628545 | Withdrawn Phase 1

• 1 other identifier: GDKM-100-08HEP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; gamma delta T cell; Allogeneic; Adoptive Treatment

Outcome Measures

Primary Outcomes (3)

• 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.

  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;)

  up to approximately 16months

• Overall Survival

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

  Up to 16months

Secondary Outcomes (5)

• ORR（objective remission rate ）

  up to approximately 16months

• TTP（time to disease progression )

  up to approximately 16months

• DoR(duration of remission )

  up to approximately 16months

• DCR (disease control rate)

  up to approximately 16months

• PFS（Progression-Free Survival )

  up to approximately 16months

Study Arms (1)

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).

Biological: GDKM-100 injection

Interventions

GDKM-100 injection BIOLOGICAL

Participants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks.

GDKM-100 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong GD Kongming Biotech LLC: lead
• Jinan University Guangzhou: collaborator

Study Sites (1)

Zhuhai People'S Hospital

Zhuhai, Guangdong, 519050, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Zhi nan Yin, PhD.MD.

  Jinan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 28, 2022
• Study Start: November 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: October 31, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)