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

NCT ID: NCT05628545

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

GDKM-100 injection

Intervention Type: BIOLOGICAL

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

Interventions

GDKM-100 injection

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Age is 18-75 years old, and gender is unlimited;

2. HCC was confirmed by pathological or clinical examination;

3. 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;

4. 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;

5. Participants volunteered to join the study, signed an informed consent, had good compliance, and cooperated with the follow-up.

Exclusion Criteria

1. Gastrointestinal bleeding, refractory ascites, hepatic encephalopathy, or hepatorenal syndrome;

2. Accept other cellular or immune clinical experiments within 8 weeks before enrollment;

3. Immunological deficiency, a known immunosuppressive disease or HIV;

4. Active infection, unexplained fever;

5. Serious or unstable heart, lung, kidney and hematopoietic system diseases;

6. Autoimmune diseases, such as rheumatoid arthritis;

7. Neurological diseases, diffuse leptomeningeal diseases; combined with neurodegenerative diseases;

8. Hormone use during cell therapy: dexamethasone dose exceeds 2mg / day during immunotherapy;

9. Pregnant or lactating women;

10. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinan University Guangzhou

OTHER

Sponsor Role: collaborator

Guangdong GD Kongming Biotech LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhi nan Yin, PhD.MD.

Role: PRINCIPAL_INVESTIGATOR

Jinan University

Locations

Zhuhai People'S Hospital

Zhuhai, Guangdong, China

Countries

China

Other Identifiers

GDKM-100-08HEP

Identifier Type: -

Identifier Source: org_study_id