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

NCT05240690 | Unknown Phase 1 DMC

• 1 other identifier: HCCSC AB04
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage IV Pancreatic Cancer; Hepatocellular Carcinoma , Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival(PFS)

  PFS is defined as the time from enrollment to the first documented disea

  24 months

Secondary Outcomes (3)

• overall survival (OS)

  24 months

• objective response rate (ORR)

  24 months

• disease control rate (DCR)

  24 months

Study Arms (1)

Umbilical Cord Blood Derived MAK Immune Cells

EXPERIMENTAL

Biological: Umbilical Cord Blood Derived MAK Immune Cells

Interventions

Umbilical Cord Blood Derived MAK Immune Cells BIOLOGICAL

Intravenous drip

Also known as: Second-line standard treatment

Umbilical Cord Blood Derived MAK Immune Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years old, under 75 years old, men and women;
• Subjects participated voluntarily, gave full informed consent, signed a written informed consent, with good compliance;
• Hepatocytic carcinoma or biliary or pancreatic-derived adenocarcinoma was clearly diagnosed by histological or cytology pathology;
• 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;
• 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;
• ECOG score of 0-1;
• Expected survival is greater than 3 months;
• 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;

You may not qualify if:

• At the same time, there are serious medical diseases, including serious heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active digestive tract ulcer;
• Patients with brain metastasis with clinical symptoms;
• 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);
• Patients with immunodeficiency or autoimmune diseases (e. g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, insulin-dependent diabetes, etc.).
• Patients who participated in other clinical trials or clinical study treatment within the 3 months prior to this clinical study.
• Patients treated with other cells within the last 6 months.
• Patients with infection and fever who were not effectively controlled.
• Patients with high allergies or a history of severe allergies.
• Patients with an albumin allergy.
• Patients after organ transplantation; patients with long-term use or who are using immunosuppressants.
• Patients with severe other organ dysfunction.
• Patients with organ bleeding, severe hypertension, and patients with a cardiac pacemaker.
• 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.
• Patients who are not considered appropriate to participate in this clinical study (e. g., poor compliance, etc.).

Sponsors & Collaborators

• Zhou Fuxiang: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases

Central Study Contacts

Fuxiang Zhou

CONTACT

+86-027-67813155; happyzhoufx@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: February 7, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)