Clinical Study of Cord Blood-Derived CAR-NK Cells in Gastric Cancer and Pancreatic Cancer

April 13, 2026 updated by: Liu Yang, Zhejiang Provincial People's Hospital

A Phase I Clinical Study of Cord Blood-Derived CAR-NK Cells Targeting Claudin18.2 in the Treatment of Advanced Gastric Cancer and Advanced Pancreatic Cancer

Main Objective: To study the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of cord blood-derived CAR-NK cells (CB CAR-NK182) targeting Claudin18.2 in patients with advanced gastric cancer and advanced pancreatic cancer.

Secondary Objective: To evaluate the efficacy of CB CAR-NK182 in patients with advanced gastric cancer and advanced pancreatic cancer: overall objective tumor response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), etc.

To evaluate the CAR-NK amplification and persistence of CB CAR-NK182 in the blood of patients with advanced gastric cancer and advanced pancreatic cancer;

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female aged 18-75 years (inclusive);
  2. Understands and voluntarily signs a written informed consent form, and is willing and able to comply with all trial requirements;
  3. Patients with advanced gastric cancer and advanced pancreatic cancer confirmed by histopathology or cytology, who have failed standard treatment or cannot tolerate standard treatment, including but not limited to: pancreatic cancer and gastric cancer;
  4. Immunohistochemical (IHC) detection of CLDN18.2, the positive expression of CLDN18.2 in tumors must be ≥ 10%;
  5. At least 1 measurable lesion according to RECIST 1.1;
  6. ECOG score is 0-1;
  7. All toxic reactions caused by previous antineoplastic therapy were resolved to grade 0-1 (according to NCI CTCAE 5.0 edition); Expected survival ≥ 12 weeks;

In addition to the primary disease, no serious hematology, heart and lung, liver and kidney disease, laboratory tests meet the following requirements:

Peripheral blood neutrophil absolute value ≥ 2000/mm3, platelet ≥ 50000/mm3 Serum creatinine ≤ 1.5mg/dL;ALT (alanine aminotransferase)/AST (aspartate aminotransferase) below 2.5 times the upper limit of normal; Total bilirubin ≤ 1.5mg/dL; Cardiac ejection fraction (EF)≥ 50%; International standard ratio (INR) or prothrombin time (PT) below 1.5 times the upper limit of normal; Activated partial coagulation time (aPTT) below 1.5 times the upper limit of normal; 10. Women of childbearing potential must have a negative serum pregnancy test and agree to effective birth control during the treatment phase and within 12 months after injection of CAR-NK cells; Male patients must agree to use effective birth control during the study and for 12 months after injection of CAR-NK cells.

Exclusion Criteria:

  1. History of other tumors;
  2. Patients who have received CAR-T,CAR-NK,TCR-T and other cell therapy targeting Claudin18.2 within 3 months before study treatment;
  3. Patients with hypersensitivity to cell therapy or any related drugs;
  4. Active autoimmune diseases;
  5. Active infections that cannot be controlled;
  6. HIV infection, uncontrolled HBV, HCV and syphilis infections;
  7. Have metastatic disease of the central nervous system (CNS), leptomeningeal disease or spinal cord compression;
  8. Patients with severe heart disease;
  9. Patients with unstable/active ulcers or bleeding from the digestive system;
  10. Patients with a history of bleeding or bleeding tendency in the digestive system;
  11. Pregnant or lactating women;
  12. There are other factors that the researcher believes are not suitable for participating in the trial.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CB CAR-NK182 Dose Escalation

Participants will receive a lymphodepleting conditioning regimen (FC regimen) followed by three intravenous infusions of Claudin18.2-targeted umbilical cord blood-derived CAR-NK cells (CB CAR-NK182) on days 0, 3, and 7. The study follows a "3+3" dose-escalation design with three planned dose levels.

Three dose levels: Dose Level 1 (2×10⁶ cells/kg/infusion on days 0, 3, and 7), Dose Level 2 (8×10⁶ cells/kg/infusion on days 0, 3, and 7), Dose Level 3 (16×10⁶ cells/kg/infusion on days 0, 3, and 7). 3-6 subjects will be enrolled per dose level. Each subject will be observed for at least 28 days after the first infusion, with a long-term follow-up period of 2 years post-first infusion.

Standard "3+3" rules apply for DLT observation and dose escalation decisions.
Drug: Cyclophosphamide
Part of the lymphodepletion regimen. Administered at 500 mg/m^2/day on Days -5 to -3 prior to the first CAR-NK cell infusion.
Drug: Fludarabine
Part of the lymphodepletion regimen. Administered at 30 mg/m^2/day on Days -5 to -3 prior to the first CAR-NK cell infusion.
Biological: CB CAR-NK18.2

Administered via intravenous infusion on Days 0, 3, and 7.

Three dose levels are planned:

Dose Level 1: 2×10^6 cells/kg/infusion Dose Level 2: 8×10^6 cells/kg/infusion Dose Level 3: 16×10^6 cells/kg/infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MTD
Time Frame: 1 month
Maximum Tolerated Dose
1 month
DLT
Time Frame: 1 month
Dose-Dependent Toxicity
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 3 years
overall survival
3 years
PFS
Time Frame: 3 years
progression-free survival
3 years
DCR
Time Frame: 3 years
Disease control rate
3 years
ORR
Time Frame: 3 years
Overall objective tumor response rate
3 years
DOR
Time Frame: 3 years
duration of response
3 years

Collaborators and Investigators

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

Sponsor

Zhejiang Provincial People's Hospital

Collaborators

Zhejiang University
Hangzhou RongGu Biotechnology Limited Company

Investigators

  • Principal Investigator: Yang Liu, M.D., Zhejiang Provincial People's Hospital

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Actual)

October 10, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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