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Clinical Trial Record

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Umbilical Cord Blood Derived MAK Immune Cells Combined With Standard Second-Line Treatments for Hepatobiliary and Pancreatic Malignancies

2022-02-07

2023-12-31

2024-12-31

27

Study Overview

Umbilical Cord Blood Derived MAK Immune Cells Combined With Standard Second-Line Treatments for Hepatobiliary and Pancreatic Malignancies

To evaluate the safety of MAK immune cells derived from umbilical cord blood combined with second-line treatments for hepatobiliary and pancreatic malignancies.And to investigate the initial efficacy of MAK immune cells derived from umbilical cord blood combined with second-line treatments for hepatobiliary and pancreatic malignancies.

N/A

  • Stage IV Pancreatic Cancer
  • Hepatocellular Carcinoma , Cholangiocarcinoma
  • BIOLOGICAL: Umbilical Cord Blood Derived MAK Immune Cells
  • HCCSC AB04

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-02-04  

N/A  

2022-02-04  

2022-02-04  

N/A  

2022-02-15  

2022-02-15  

N/A  

2022-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Umbilical Cord Blood Derived MAK Immune Cells

BIOLOGICAL: Umbilical Cord Blood Derived MAK Immune Cells

  • Intravenous drip
Primary Outcome MeasuresMeasure DescriptionTime Frame
Progression-free Survival(PFS)PFS is defined as the time from enrollment to the first documented disea24 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
overall survival (OS)OS is the time from enrollment to death due to any cause.24 months
objective response rate (ORR)and partial response (PR) by the investigator according to the RECIST 1.1.24 months
disease control rate (DCR)DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Fuxiang Zhou

Phone Number: +86-027-67813155

Email: happyzhoufx@sina.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Age over 18 years old, under 75 years old, men and women; 2. Subjects participated voluntarily, gave full informed consent, signed a written informed consent, with good compliance; 3. Hepatocytic carcinoma or biliary or pancreatic-derived adenocarcinoma was clearly diagnosed by histological or cytology pathology; 4. Recurrent hepatobiliary or pancreatic malignancies with unresectable advanced or metastatic, or postoperative adjuvant therapy (chemotherapy and / or radiation therapy) for 12 months, with a Child-Pugh score of 7; 5. With 1 measurable lesion, according to the RECIST v 1.1 criteria.Requirements: The selected target lesion has not previously received local treatment, or the selected target lesion was located in the previous local treatment area after passing the imaging examination and was determined as PD according to the RECIST v 1.1 criteria; 6. ECOG score of 0-1; 7. Expected survival is greater than 3 months; 8. Main organ function composite with the following requirements:

  • Absolute neutrophil count was 1.5*10^9 / L;
  • Platelet count was 75*10^9 / L;
  • Hemoglobin was at 90g / L;
  • Serum albumin at 30g / L;
  • Serum bilirubin 1.5 upper Range normal limit (ULN);
  • Altraverine aminotransferase (ALT), aspartate aminotransferase (AST) 2.5 upper normal range limit (ULN);
  • Serum creatinine (Cr) 1.5 Upper Limit of normal range (ULN) or Cr clearance of 40 mL/min;
  • The International standardized ratio (INR) 2 or Prothrombin Time (PT) exceeds the upper limit of the normal range for 6 seconds;
  • Urinary protein <2 + (if urine protein 2 +, 24 h (h), and 24h <1.0g can be enrolled).

    • 9.If HBsAg (+) and / or HBcAb (+), HBV DNA must be <500IU / mL and during the study period, the original anti-HBV treatment continues throughout the study, or start entecavir or teenofavir.
    10.There is no previous history of abdominal radiotherapy. If radiation has been performed, the complete target area scope and treatment plan are more than 2 weeks apart from the study immune cell transfusion of this project; 11.No history of organ transplantation; 12.Women of childbearing age performed a serum pregnancy test within 7 days before the initiation of treatment, and agreed to adopt a reliable and effective contraceptive method during the trial and within 60 days after the final administration of the test drug.For male subjects with a partner of women of childbearing age, consent was given to a reliable and effective approach to contraception during the trial and within 60 days after the final administration of the test medication.
    Exclusion Criteria:
    1. At the same time, there are serious medical diseases, including serious heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active digestive tract ulcer; 2. Patients with brain metastasis with clinical symptoms; 3. Suffering from other primary malignancies in the past 5 years (except skin BCC or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled); 4. Patients with immunodeficiency or autoimmune diseases (e. g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, insulin-dependent diabetes, etc.). 5. Patients who participated in other clinical trials or clinical study treatment within the 3 months prior to this clinical study. 6. Patients treated with other cells within the last 6 months. 7. Patients with infection and fever who were not effectively controlled. 8. Patients with high allergies or a history of severe allergies. 9. Patients with an albumin allergy. 10. Patients after organ transplantation; patients with long-term use or who are using immunosuppressants. 11. Patients with severe other organ dysfunction. 12. Patients with organ bleeding, severe hypertension, and patients with a cardiac pacemaker. 13. Women during pregnancy or lactation; or women of childbearing age have positive blood pregnancy, women of childbearing age and their spouses are unwilling to take effective contraception during the clinical study and within 6 months of the end. 14. Patients who are not considered appropriate to participate in this clinical study (e. g., poor compliance, etc.).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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