Clinical Study of MAK Immune Cells in the Treatment of PHC

NCT05242757 | Unknown

• 1 other identifier: Zhongnan Hospital
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Other: Mixed-activated Killer Immune Cells

Interventions

Mixed-activated Killer Immune Cells OTHER

Mixed-activated Killer Immune Cells Peripheral intravenous infusion therapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years old, regardless of gender.
• Patients with primary hepatocellular carcinoma.
• 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.
• The expected survival time is ≥6 months.
• Peripheral blood white blood cell count ≥3×10\^9 /L.
• Understand and voluntarily sign the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Hubei, Wuhan, 430071, China

RECRUITING

Related 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.

  PMID: 33782566 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Qifa Ye, MD, PHD

  Wuhan University

  STUDY CHAIR

Central Study Contacts

Wenjin Liang, MD

CONTACT

+86-02767812988; 190679136@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: February 16, 2022
• Study Start: January 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: February 16, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)