Clinical Study of MAK Immune Cells in the Treatment of PHC

Not Applicable

• Conditions: Primary Hepatocellular Carcinoma
• Interventions: Other: Mixed-activated Killer Immune Cells

• Registration Number: NCT05242757
• Lead Sponsor: Zhongnan Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-11
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-16
• Last Update Posted: 2022-02-16
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
To evaluate the safety and reliminary efficacy of MAK immune cells in the treatment of PHC.	Mixed-activated Killer Immune Cells	To evaluate the safety and reliminary efficacy of MAK immune cells in the treatment of primary hepatocellular carcinoma.

Primary Outcome Measures

Name	Time	Method
The size (tumor diameter) and number (tumor recurrence lesions) of PHC tumors were examined by enhanced abdominal CT	three months	At baseline and 1, 2 and 3 months after the last cell transfusion, a total of 4 abdominal enhanced CT examinations were performed to count the tumor size (tumor diameter) and number of tumor recurrence lesions.
Detecting the dynamic changes of circulating tumor cell count ( > 4 CTC counts per milliliter of blood acted as positive )	three months	Peripheral blood was collected 6 times at baseline, 24 hours after two MAK cell transfusions, and 1, 2, and 3 months after the last MAK cell transfusions to detect the changes in the number of circulating tumor cells ( \> 4 CTC counts per milliliter of blood acted as positive ).

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Hubei, Wuhan, China