Clinical Study of MAK Immune Cells in the Treatment of PHC

Zhongnan Hospital

Status: Unknown

Conditions: Primary Hepatocellular Carcinoma

Treatments: Other: Mixed-activated Killer Immune Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT05242757

Zhongnan Hospital

Details and patient eligibility

About

The investigators will plan to recruit 20 patients with liver cancer CNLC stage Ⅲa and Ⅲb who are older than 18 years old. Peripheral blood mononuclear cells were obtained and then the MAK(Mixed-activated Killer) cells were injected, and then the safety and efficacy were observed.

Full description

The investigators will plan to recruit 20 patients with liver cancer CNLC stage Ⅲa and Ⅲb who are older than 18 years old. Peripheral venous blood was collected twice (50-60ml/time, 2 times, 1 week apart) from each patient. Peripheral blood mononuclear cells were separated, induced, expanded, and cultured in vitro for a total of 1 week to obtain physiological conditions Immune cell populations with tumor-killing activity (mainly MAK immune cells mainly CD3-CD16 + CD56 + and CD3 + CD56 +), and then the MAK(Mixed-activated Killer) cells were injected intravenously for three days. Observe that the patient received cell therapy 24h, The safety and efficacy of 1 month, 2 months, and 3 months, and monitoring of adverse reactions.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age over 18 years old, regardless of gender.
2. Patients with primary hepatocellular carcinoma.
3. According to the "Regulations for Diagnosis and Treatment of Primary Liver Cancer (2019 Edition)" by the Health Commission of the People's Republic of China Liver cancer staging scheme, patients with Ⅲa and Ⅲb.
4. The expected survival time is ≥6 months.
5. Peripheral blood white blood cell count ≥3×10^9 /L.
6. Understand and voluntarily sign the informed consent form.

Exclusion criteria

1. Patients with immunodeficiency or autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, multiple Primary sclerosis, insulin dependent diabetes, etc.).
2. Patients with a history of other malignant tumors in the past 5 years.
3. Patients who participated in other clinical trials or clinical research treatments within 3 months before this clinical study By.
4. Patients who have received other cell therapy within the past 6 months.
5. Patients with fever who have not effectively controlled the infection.
6. Patients with high allergies or a history of severe allergies.
7. Patients who are allergic to albumin.
8. Patients after organ transplantation; patients who have been using or are using immunosuppressive agents for a long time.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

To evaluate the safety and reliminary efficacy of MAK immune cells in the treatment of PHC.

Experimental group

Description:

To evaluate the safety and reliminary efficacy of MAK immune cells in the treatment of primary hepatocellular carcinoma.

Treatment:

Other: Mixed-activated Killer Immune Cells