Evaluation of the safety and efficacy of allogeneic activated Natural killer cells in metastatic Colon Adenocarcinoma

Phase 1

Recruiting

Conditions: Patients with metastatic colon adenocarcinoma.
Malignant neoplasm of colon, unspecified
C18.9

Registration Number: IRCT20230704058675N1

Lead Sponsor: Middle East Gene Therapy corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

The expected survival period of the participants is at least 6 months
Patients with metastatic colon adenocarcinoma who have failed at least two standard lines of treatment and no other viable and effective treatment is available.
It should be possible to evaluate the metastatic lesion in the participants by radiological approaches. (CT and MRI)
The physical condition score of ECOG participants is 0-2.
Participants should have proper liver, kidney, and bone marrow function. Laboratory screening must meet the following criteria for all laboratory tests. WBC = 1.5 x 109/L. PLT platelet count =60×109/L. Hemoglobin Hb content of 8.0 g/dL or higher. Lymphocyte LYM=0.4×109/L. Serum creatinine =1.5 × ULN, if serum creatinine > 1.5 × ULN, creatinine clearance rate > 50 mL/min (calculated according to the Cockcroft-Gault formula). Total serum bilirubin =1.5×ULN, ALT=2×ULN, AST=2×ULN (patients with liver metastasis or liver cancer) ALT=5 x ULN, AST=5 x ULN). Amylase and lipase = 1.5 × ULN. Urine protein < 2+
Participants must be willing and able to comply with planned treatment regimens, laboratory tests, follow-up visits, and other study requirements.
Participants should be HIV negative and don't have active hepatitis B and C

Exclusion Criteria

Patients with (MSI-H) phenotype will not be included in the study. (Patients with MSS molecular status will be included in the study).
Patients with metastasis in CNS or BM
Prior immunotherapy with NK or CAR-NK
received anti-PD-1/PD-L1 monoclonal antibody therapy within 4 weeks prior to treatment
Patients who have previously received other gene therapies
Patients who participated in other clinical studies in the last 1 month
Participants who have not received a maximum of 2 series of intermittent TB therapy out of 6 series of cell injections.
known history of human immunodeficiency virus (HIV) infection; acute or chronic active hepatitis B (HBsAg positive); Acute or chronic active hepatitis C (HCV antibody positive). Syphilis antibody positive; DNA quantity of Epstein-Barr virus 500 copies; Cytomegalovirus (CMV) infection (IgM positive).
Severe infection that is active or clinically poorly controlled.
Existing heart disease requiring treatment or hypertension not well controlled by the investigator (systolic blood pressure =140 mmHg and/or diastolic blood pressure >90 mmHg after treatment).
The presence of any clinical symptoms or heart diseases (ischemic heart disease, heart failure and arrhythmia)
Patients with chronic lung, heart and liver diseases.
Patients with active autoimmune disease; Rheumatoid arthritis, inflammatory bowel disease, celiac disease, systemic lupus erythematosus, scleroderma and multiple sclerosis.
Patients taking immunosuppressive drugs, including tacrolimus, mycophenolate mofetil, sirolimus, and cyclosporine A.
Patients with psychiatric diseases from whom it is not possible to obtain informed consent.
Abnormal coagulation function (INR > 1.5), bleeding tendency, or receiving thrombolytic or conventional anticoagulant therapy (eg, warfarin or heparin) in patients requiring long-term antiplatelet therapy (aspirin > 300 mg/day; clopidogrel, dose > 75 mg per day).
People requiring systemic treatment with corticosteroids or other immunosuppressive agents during the course of treatment.
Known past or present hepatic encephalopathy requiring treatment. Patients who currently have or have a history of central nervous system disorders such as epilepsy, seizures, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with central nervous system involvement.
Patients with previous or simultaneous malignancy
Participants who drop out of the study for various reasons and cannot participate in the study again

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of response to treatment. Timepoint: before the start of the study and one month after the last intervention. Method of measurement: The amount of tumor markers in the blood (CEA, CA19.9).;Evaluation of response to treatment. Timepoint: before the start of the study and one month after the last intervention. Method of measurement: Radiological evaluations of metastatic lesions.

Secondary Outcome Measures