Autologous Killer Cell Therapy in Colon Cancer Patients

Sabz Biomedicals

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Colon Cancer Stage IV

Treatments: Other: Chemotherapy AND/OR Radiation Therapy; Biological: Cytokine-induced killer cell

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03329664

Autologous Killer cell therapy

Details and patient eligibility

About

This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Patients in both groups will receive the same therapeutic regimen as usual. Patients in one group additionally will be treated with a single infusion of autologous killer cells that had been previously prepared from peripheral blood.

Enrollment: 20 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically confirmed colorectal cancer at stage IV
• ECOG performance status 0-2
• Adequate cardiac/renal/hepatic function
• Adequate bone marrow function (blood cell count)

Exclusion criteria

• Patients that have received prior chemotherapy or immune cell therapy
• Patients that have previously participated in another clinical trial
• History of positive test result for HIV, HBV, HCV, HTLV-1, syphilis
• Presence of Active infections
• Patients with immunodeficiencies, autoimmunities, or severe allergies
• Receiving immunosuppressive regimens

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

CIK Intervention plus routine treatment

Experimental group

Description:

Patients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion

Treatment:

Biological: Cytokine-induced killer cell

Other: Chemotherapy AND/OR Radiation Therapy

Control

Active Comparator group

Description:

Patients who receive routine treatments only (chemotherapy, radiation therapy)

Treatment:

Other: Chemotherapy AND/OR Radiation Therapy