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Study on the Safety and Effectiveness of UCB-NK Cell Infusion in the Treatment of Advanced Gastric Cancer and Gastroesophageal Cancer

NCT04385641 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-05-13

No results posted yet for this study

Summary

This study is an open, single infusion, cell infusion dose /method exploration study. In patients with gastric cancer and gastroesophageal cancer without effective treatment, the safety of UCB-NK cell immunotherapy was evaluated and the preliminary curative effect results were obtained.

Conditions

Interventions

OTHER

Cell infusion for Dose-finding (Group A)

Group A：HLA-I and HLA-II molecular typing were performed at the serological and molecular levels, and the HLA-I and HLA-II molecular antigens of donor and subjects match on 3, 4, 5 or 6 / 6. After the successful matching, the non myeloablative immunosuppressive pretreatment with cyclophosphamide (900 mg / m＾2 / day) and fludarabine (30 mg / m＾2 / day) will be performed 6, 5, 4 and 3 days before the infusion of UCB-NK cells. After the pretreatment, the cell infusion was started on day 0, and the cell infusion could be divided into 50% and 50% for two consecutive days or every other day. To ensure clinical safety, if treatment-related adverse events reach DLT after the first infusion, the cell infusion will stop.

OTHER

Cell infusion for Extended research (Group B)

Group B：Non myeloablative immunosuppressive pretreatment and cell transfusion were the same as group A.

Sponsors & Collaborators

  • Shandong Golden Brick Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2021-10-08
Completion
2022-10-08

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04385641 on ClinicalTrials.gov