The phase I clinical study about the combined therapy, high purity natural killer (NK) cell therapy and IgG1 antibody to inoperable advance and recurrence digestive cancer

The phase I clinical study about the combined therapy, high purity natural killer (NK) cell therapy and IgG1 antibody to inoperable advance and recurrence digestive cancer - The phase I clinical study about the combined therapy, natural killer (NK) cell therapy and IgG1 antibody to digestive cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013378

Enrollment

Registered

2014-06-30

Start date

2014-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inoperable advance and recurrence stomach and colon cancer combined with IgG1 antibody in chemotherapy

Interventions

Intravenous transfer of autologous NK cells. Dose-escalation study with three groups 1)5x10*8 cells 3 patients 2)1x10*9 cells 3 patients 3)2x10*9 cells 3 patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed gastric or colon cancer. 2) Patients informed diagnosis of their disease 3) In gastric cancer, patient must be cared with Capecitabine + Cisplatin + Trastuzumab or S-1 + Cisplatin + Trastuzumab chemotherapy regimen. In colon cancer, patient must be cared with Capecitabine + Oxaliplatin + Cetuximab or S-1 + Oxaliplatin + Cetuximab chemotherapy regimen. 4) Aged from 20 to 80 years 5) Grade 0 to 2 in performance status (ECOG). 6) Lasting at least four weeks since previous cell infusion therapy. 7) Sufficient functions of major organ. 8) Expected to be alive at least four months after informed consent. 9) Having written informed consent.

Exclusion criteria

Exclusion criteria: 1) Presence of uncontrolled infection 2) Hypersensitivity or autoimmune disease requiring treatments 3) Presence of severe comlications(malignant hypertension, congestive heart failure, severe coronary disease, history of myocardial infarction less than six months prior, pulmonary fibrosis or active interstitial pneumonitis) 4) Inappropriate patients for this study due to severe complications. 5) Patient who cannot undergo enhanced CT scan or MRI due to some reason such as allergy for contrast media or renal dysfunction. 6) Active other malignancy, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable. 7) Medical history of severe hypersensitivity. 8) Severe mental impairment 9) Pregnant or lactating women 10) Patient with HBV, HCV, HIV, HTLV-1 or syphilis infection 11) Inappropriate patients for study judged by the physicians. 12) Patient with bad NK cell cultivation.

Design outcomes

Primary

Measure	Time frame
To assess the kind, grade and frequency of adverse event about combined therapy with the cultivated NK cell and IgG1 antibody.	—

Countries

Japan

Contacts

Public ContactTakeshi Ishikawa

Kyoto Prefectural University of Medicine Cancer ImmunoCell Regulation

iskw-t@koto.kpu-m.ac.jp075-251-5519

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026