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Clinical Trials/IRCT20230704058675N1
IRCT20230704058675N1
Recruiting
Phase 1

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

Middle East Gene Therapy corporation0 sites10 target enrollmentTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Middle East Gene Therapy corporation
Enrollment
10
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Middle East Gene Therapy corporation

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Not specified

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