An exploratory clinical study on the safety of combination therapy with effector cell therapy and immune checkpoint inhibitors.

An exploratory clinical study on the safety of combination therapy with effector cell therapy and immune checkpoint inhibitors. - An exploratory clinical study on the safety of combination therapy with effector cell therapy and immune checkpoint inhibitors.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028756

Enrollment

Registered

2017-08-22

Start date

2017-09-14

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

Malignant tumor

Interventions

Alpha beta T-cell therapy Nivolumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patient MUST: (1)Have enrolled in "Multicenter clinical study of immune-cell therapy in patients with malignant tumors" (UMIN ID: UMIN000019030). (2)Have measurable lesions of tumors. (3)Be 0 of PS score. (4)Be confirmed in decrease in the number of lymphocytes in the test of cell surface marker by specified peripheral blood flow cytometry prior to initiating treatment. (5)Obtain an undyed tissue section. (6)Received Alpha beta T-cell therapy more than twice at Seta Clinic Group, and the last treatment has been within 12 months. (7)Have adequate function of main organs (heart, lung, liver, kidney, and bone marrow) at the time of eligibility confirmation. (8)Be expected to survive for more than 4 months from the time of eligibility confirmation. (9)Obtain their doctor's consent about participation in this study. (10)Have secured medical facilities that can hospitalize in case of emergency. (11)Provide written consent to participate this study.

Exclusion criteria

Exclusion criteria: A patient MUST NOT: (1)Have treated with immune checkpoint inhibitors. (2)Be a female who is pregnant, lactating, or with a possibility of pregnancy. (3)Be determined to be inappropriate by the doctor in charge.

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Efficacy Immunological response	—

Countries

Japan

Contacts

Public ContactEri Oguma

KOUSHIKAI,Non-profitmedicalcorporation Center for Clinical Trials and Research

citeg@j-immunother.com03-5244-5751

Outcome results

None listed

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