Clinical trial NCT05628545: Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
Official title: Clinical Study on Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
gamma delta T cell
Allogeneic
Adoptive Treatment
Lead sponsor: Guangdong GD Kongming Biotech LLC
Sponsor class: INDUSTRY
Collaborators: name: Jinan University Guangzhou
First posted: 2022-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The change of performance status score
timeFrame: up to approximately 16months
measure: The Child-Pugh score
timeFrame: up to approximately 16months
measure: Overall Survival
timeFrame: Up to 16months
Secondary outcomes:
measure: ORR（objective remission rate ）
timeFrame: up to approximately 16months
measure: TTP（time to disease progression )
timeFrame: up to approximately 16months
measure: DoR(duration of remission )
timeFrame: up to approximately 16months
measure: DCR (disease control rate)
timeFrame: up to approximately 16months
measure: PFS（Progression-Free Survival )
timeFrame: up to approximately 16months
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Zhuhai People'S Hospital
state: Guangdong
Study officials:
affiliation: Jinan University
name: Zhi nan Yin, PhD.MD.
role: PRINCIPAL_INVESTIGATOR
References: