Phase 1 clinical study of highly purified natural killer (NK) cell infusion for patients with refractory digestive/gastrointestinal cancer to standard therapy

Phase 1 clinical study of highly purified natural killer (NK) cell infusion for patients with refractory digestive/gastrointestinal cancer to standard therapy - Phase 1 clinical study of NK cell infusion for patinets with digestive/gastrointestinal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007527

Enrollment

Registered

2012-04-01

Start date

2012-04-01

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

refractory digestive/gastrointestinal cancer

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 digestive/gastrointestinal cancer. 2) Patients informed diagnosis of their disease 3) Patients must have refractory disease to standard treatment, and in the situation where curative treatment opions are not available. 4) Without planning to recieve chemotherapy, radiation therapy or immunotherapy. Oral 5-FU drugs are permitted. 5) Aged from 20 to 80 years 6) Grade 0 to 2 in performance status(ECOG). 7) Sufficient functions of major organ. 8) Expected to be alive at least three months after informed consent. 9) Lasting at least four weeks since the previous chemotherapy or radiotherapy, or two weeks since the previous administration of 5-FU. But oral 5-FU drugs are permitted. 10) 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.

Design outcomes

Primary

Measure	Time frame
safety	—

Secondary

Measure	Time frame
anti-tumor effect	—

Countries

Japan

Contacts

Public ContactIshikawa Takeshi

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