Clinical Study of MAK Immune Cells in the Treatment of PHC

Primary Hepatocellular Carcinoma Clinical Trial

Official title:

Clinical Study on the Safety and Efficacy of Mixed-activated Killer Immune Cells in the Treatment of Primary Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242757
• Other study ID #: Zhongnan Hospital
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: November 2021
• Source: Zhongnan Hospital
• Contact: Wenjin Liang, MD
• Phone: +86-02767812988
• Email: 190679136[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?a and ?b.

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Primary Hepatocellular Carcinoma

Intervention

Other:
• Mixed-activated Killer Immune Cells
Mixed-activated Killer Immune Cells Peripheral intravenous infusion therapy

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Hubei	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Morotti M, Albukhari A, Alsaadi A, Artibani M, Brenton JD, Curbishley SM, Dong T, Dustin ML, Hu Z, McGranahan N, Miller ML, Santana-Gonzalez L, Seymour LW, Shi T, Van Loo P, Yau C, White H, Wietek N, Church DN, Wedge DC, Ahmed AA. Promises and challenges of adoptive T-cell therapies for solid tumours. Br J Cancer. 2021 May;124(11):1759-1776. doi: 10.1038/s41416-021-01353-6. Epub 2021 Mar 29. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detecting the dynamic changes of circulating tumor cell count ( > 4 CTC counts per milliliter of blood acted as positive )	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 ).	three months
Primary	The size (tumor diameter) and number (tumor recurrence lesions) of PHC tumors were examined by enhanced abdominal CT	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.	three months