Condition 1: gastrointestinal cancers (colon cancer). Condition 2: gastrointestinal cancers (pancreatic). Condition 3: gastrointestinal cancers (Stomach). Malignant neoplasm of colon, unspecified Malignant neoplasm of pancreas, unspecified Malignant neoplasm of stomach, unspecified
Conditions
Interventions
Intervention group : This phase I, single-arm, open-label, non-randomized clinical trial aims to evaluate the safety and initial efficacy of allogeneic NK cell therapy administered concomitantly with
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients older than 20 years of age Pancreatic, colon or gastric cancer in stage III or IV with no response to standard treatment No cardiovascular disease or organ failure Leukocyte count = 3000/3 mm, platelets = 100000/3 mm and hemoglobin g/dL = 9.0 Liver enzyme alanine aminotransferase (ALT) and aspartate transaminase (AST) and bilirubin levels are ALT = 100 IU/L, AST = 100 IU/L, total bilirubin = 2 mg/dL, respectively Creatinine level = 1.5 mg/dL Blood urine nitrogen (BUN) level = 25 mg/dL Patient's Karnofsky status above 70% ECOG performance status less than or equal to 1 Patients should read and sign the informed consent form
Exclusion criteria
Exclusion criteria: Patients who are hepatitis B virus (HBV), hepatitis Cvirus (HCV), human immunodeficiency virus (HIV) and Human T-lymphotropic Virus (HTLV1) positive Patients who have active infection Patients who have severe diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the intervention based on the incidence of adverse events associated with concomitant treatment with allogeneic NK cells and standard chemotherapy according to CTCAE v5.0 criteria. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Recording the number and severity of each complication, the time of occurrence, and its relationship to treatment based on examinations and patient statements following patient visits to the bone marrow transplant clinic for follow-up. Safety criteria are based on CTCAE (Common Terminology Criteria for Adverse Events) for adverse events.;Determining the maximum tolerated dose. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Based on the dose-escalation algorithm, it is determined after the end of each phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response to treatment was based on the defined Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) defined by the international working group of NCI-USA, EORTC, and NCI-Canada. Timepoint: From the first dose of NK cells infusion every 6-8 weeks until six months after the last dose. Method of measurement: Regular patient examinations at the bone marrow transplant clinic for monitoring and CT or MRI imaging, classification of responses into PR (Partial Response), CR (Complete Response), Stable Disease (SD), Progressive Disease (PD) based on RECIST 1.1.;Progression-free survival, PFS. Timepoint: From the first dose of NK cell infusion until disease progression based on RECIST 1.1 or death occurs, up to six months after the last dose. Method of measurement: Regular visits of patients to the bone marrow transplant clinic for ongoing monitoring with imaging and regular follow-up.;Overall survival. Timepoint: From the first dose of NK cell infusion until death from any cause up to six months after the last dose of infusion. Method of measurement: Long-term follow-up and monitoring of patients (OS follow-up will be conducted for at least 6 months after the last dose, and longer data will be collected in post-study follow-up.;Rate and time to recurrence. Timepoint: Duration and percentage of patients who relapse from the first dose of NK cell infusion to 6 months after the last dose. Method of measurement: Recurrence monitoring based on clinical assessment and imaging every 6 weeks to six months. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElham Roshandel
Shahid Beheshti University of Medical Sciences
Outcome results
None listed