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Clinical Study of MAK Immune Cells in the Treatment of PHC

Primary Purpose

Primary Hepatocellular Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Mixed-activated Killer Immune Cells

About this trial

This is an interventional other trial for Primary Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Zhongnan Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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 ).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05242757

First Posted

December 14, 2021

Last Updated

February 7, 2022

Sponsor

Zhongnan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05242757

Brief Title

Clinical Study of MAK Immune Cells in the Treatment of PHC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

March 31, 2022 (Anticipated)

Study Completion Date

March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhongnan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Mixed-activated Killer Immune Cells

Intervention Description

Mixed-activated Killer Immune Cells Peripheral intravenous infusion therapy

Primary Outcome Measure Information:

Title

Detecting the dynamic changes of circulating tumor cell count ( > 4 CTC counts per milliliter of blood acted as positive )

Description

Time Frame

three months

Title

The size (tumor diameter) and number (tumor recurrence lesions) of PHC tumors were examined by enhanced abdominal CT

Description

Time Frame

three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenjin Liang, MD

Phone

+86-02767812988

190679136@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qifa Ye, MD, PHD

Organizational Affiliation

Wuhan University

Official's Role

Study Chair

Facility Information:

Facility Name

Zhongnan Hospital of Wuhan University

City

Hubei

State/Province

Wuhan

ZIP/Postal Code

430071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qifa Ye, PHD,MD

Phone

67812988

190679136@qq.com

First Name & Middle Initial & Last Name & Degree

Wenjin Liang, PHD

Phone

67812988

190679136@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33782566

Citation

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.

Results Reference

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Clinical Study of MAK Immune Cells in the Treatment of PHC

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