2DG-abT therapy for malignant tumors

JRCT ID: jRCTc030210184

Registered date:05/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: malignant tumor
• Date of first enrollment: 06/12/2021
• Target sample size: 3
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

blood collection for cell culture and tests.
Administration of therapeutic cells 3 times.

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Efficacy, Immunological response

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Be diagnosed with malignant tumor by imaging findings or pathological or cytological study.
(2)Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1.
(3)Be 20 years of age or older.
(4)Visit outpatient department on schedule.
(5)Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed.
(6)Provide written consent to participate this study.

Exclude criteria

(1)Be apparent from the clinical manifestation of pulmonary fibrosis or interstitial pneumonia.
(2)Have a history of a serious drug allergy.
(3)Have a positive result of HIV antibody.
(4)Have a serious cardiac disorder.
(5)Have an active autoimmune disorder.
(6)Have a concurrent cancer.
(7)Have an infectious disorder that is difficult to control.
(8)Be a female who is pregnant, lactating, or with a possibility of pregnancy.
(9)A patient who is judged as inadequate for enrolment by doctors is excluded

Related Information

• Primary Sponsor: Takimoto Rishu
• Source(s) of Monetary Support: MEDINET Co., Ltd.