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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

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ClinicalTrials.gov Identifier: NCT04385641
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Shandong Golden Brick Biotechnology Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Gastroesophageal Cancer Other: Cell infusion for Dose-finding (Group A) Other: Cell infusion for Extended research (Group B) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Safety and Effectiveness of UCB-NK Cell Infusion in the Treatment of Advanced Gastric Cancer and Gastroesophageal Cancer
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : October 8, 2021
Estimated Study Completion Date : October 8, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose-finding (Group A)
In this study, the dose was explored according to the "3+3" mode, in which group A was divided into three dose groups: 1.5*10^9 group, 2*10^9 group and 3*10^9 group. If DLT occurs in one of the first three subjects in each dose group within four weeks after cell infusion, three subjects will continue to be included. If more than 1/6 cases of DLT appear in 6 subjects with 1.5*10^9 dose, the dose level and/or cell infusion frequency and method will be reduced after discussion between the investigator, the collaborator and DMC. If DLT did not occur in the first 3 subjects within 4 weeks after receiving 1.5*10^9 cell infusion,another three subjects were enrolled into the group received 2*10^9 cell infusion. DLT did not occur within 4 weeks after cell infusion, it will increase to 3*10^9 dose group. That is to say, the first three subjects were included for observation for 4 weeks in the 3*10^9 dose group, if DLT did not occur, there will be another 3 cases, reaching to 6 subjects.
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.

Experimental: Extended research (Group B)
If DLT≤1/6, the dose will not be increased. This dose will also be used as the treatment dose of group B. If DLT is more than 1/6 in the 3*10^9 dose group, three subjects will be added in 2*10^9 dose group. If DLT ≤1/6 in 4-week observation, the 2*10^9 will be the maximum tolerable dose, and will be used as the treatment dose of group B. The subjects in group A were enrolled first, after at least 4 weeks of observation for all subjects, six subjects will be included in group B.
Other: Cell infusion for Extended research (Group B)
Group B:Non myeloablative immunosuppressive pretreatment and cell transfusion were the same as group A.




Primary Outcome Measures :
  1. Safety assessment [ Time Frame: 4 weeks ]
    Evaluation of adverse events and severity according to CTCAE v5.0

  2. Hematology toxicity [ Time Frame: 7 days ]
    After 7 days of treatment, the ≥ 4 degree hematotoxicity (excluding lymphocyte reduction) related to UCB-NK treatment could not recover to ≤ 3 degree

  3. Non hematologic toxicity [ Time Frame: 7 days ]
    Any non hematologic toxic reaction≥4 degree related to UCB-NK treatment cannot be reduced to≤3 degree within 3 days and no further improvement is found; Gastric mucosal injury including gastric hemorrhage≥3 degree related to UCB-NK treatment; Other non hematologic toxicity≥3 degree related to UCB-NK treatment lasted for more than 7 days.


Secondary Outcome Measures :
  1. Tumor assessment [ Time Frame: 4 years ]

    Imaging of the chest, abdomen and pelvis (either enhanced CT or MRI) and tumor markers should be obtained at baseline (before the pretreatment of first lymphocyte clearance), this imaging evaluation is the baseline examination of this study. After the infusion, patients need to return to the hospital at the 1st, 2nd, 3rd, 4th, 6th and 12th month (± 7 days) and every 6 months (± 1 month) after the 12th month to check the imaging of chest, abdomen and pelvis and tumor markers. Follow up to the disease progress, unwilling to be followed up, loss of follow-up, death or the end of the study, whichever occurs first.

    Imaging evaluation is up to the established disease progression (PD) according to the RECIST 1.1.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1)Patients with advanced gastric cancer or gastroesophageal cancer confirmed by pathology and failed in standard treatment; 2)ECOG scores≤1; 3)Expected life>12 weeks; 4)According to RECIST1.1,there is at least one target lesion that can be stably evaluated, defining as: the longest diameter of non lymph node lesions ≥ 10 mm, or the short diameter of lymph node ≥ 15mm; 5)Sufficient vein access for monocyte collection; 6)Hematology parameters meet the following requirements: Neutrophil absolute value≥1.5×109 / L; Leukocyte≥4.0×109 / L; Hemoglobin≥80g / L; Platelets≥75×109 / L; 7) Liver function meets the following conditions: Total bilirubin≤1.5×ULN (no liver metastasis); Aspartate aminotransferase≤2.5×ULN (no liver metastasis); Alanine aminotransferase≤2.5×ULN (no liver metastasis); Alkaline phosphatase≤2.5×ULN (no liver metastasis); Total bilirubin≤2×ULN (with liver metastasis); Aspartate aminotransferase≤5.0×ULN (with liver metastasis); Alanine aminotransferase≤5.0×ULN (with liver metastasis); Alkaline phosphatase≤5.0×ULN (with liver metastasis); 8) Renal function meets the following conditions: Serum creatinine≤1.5×ULN; 9) Coagulation function meets the following conditions: International standardization ratio (INR) ≤1.5; Apart prothrombin (PTT或 APTT) ≤1.5×ULN; 10) Heart function meets the following conditions: Left ventricular ejection fraction (LVEF)≥50%; 11) The subjects can communicate well with the researchers and follow the visit, treatment, laboratory examination and other relevant regulations; 12) Female and male subjects of childbearing age agree to take effective contraceptive measures throughout the study period up to 6 months after completion of administration; 13) The subjects must give informed consent to the study before the trial and sign the written informed consent voluntarily.

Exclusion Criteria:

  • 1)Serious or uncontrollable heart disease,including: Congestive heart failure with NYHA grade 3 or 4; Unstable angina beyond the control of drugs; History of myocardial infarction six months before the selection; Serious arrhythmia requiring medication; 2)Other malignant tumors occurred in the past 5 years; 3)≥ grade 3 peripheral neuropathy; 4)Patients with active infections (viruses, bacteria or fungi) requiring special treatment 5) Active hepatitis B or hepatitis C; current or past alcoholism; cirrhosis; 6)Human immunodeficiency virus ( HIV) positive; 7)According to the judgment of researchers, uncontrollable systemic diseases, including: diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, glaucoma, immune disease, pleural effusion or peritoneal effusion with symptoms requiring drainage, etc; 8)Pregnant or lactating women; 9)Baseline measurement, QTc interval, male > 450 ms, female > 470 ms; 10)Other unsuitable conditions judged by researchers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385641


Contacts
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Contact: Zhaoyong Yang, MD 18513385316 zhaoyongy@imb.pumc.edu.cn

Locations
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China
Changguo hospital of Zibo Recruiting
Zibo, China
Sponsors and Collaborators
Shandong Golden Brick Biotechnology Co., Ltd.
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Responsible Party: Shandong Golden Brick Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04385641    
Other Study ID Numbers: IH-UCB-NK-422
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shandong Golden Brick Biotechnology Co., Ltd.:
UCB-NK cell infusion
safety
effectiveness
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases