Clinical trial · Interventional
Study on the Safety and Effectiveness of UCB-NK Cell Infusion in the Treatment of Advanced Gastric Cancer and Gastroesophageal Cancer
NCT04385641CI-TRIAL-00045074unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cell infusion for Dose-finding (Group A) | Other | — | UNRESOLVED |
| Cell infusion for Extended research (Group B) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose-finding (Group A)
- description
- 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.
- interventionNames
- Other: Cell infusion for Dose-finding (Group A)
- type
- EXPERIMENTAL
- label
- Extended research (Group B)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.