Evaluation of immunological parameters in high risk group of cancer treated with immune-cell therapy

JRCT ID: jRCTc030240165

Registered date:14/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: cancer prevention
• Date of first enrollment: 14/06/2024
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

blood collection for cell culture and tests.
Administration of therapeutic cells 1 times.

Outcome(s)

• Primary Outcome: Immunological response
• Secondary Outcome: Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Have risk factors for cancer and desire for receiving the preemptive immune-cell therapy.
(2)Be > 18 of age when obtaining the informed consent.
(3)Be determined to be appropriate by the doctor in charge.
(4)Provide written informed consent.

Exclude criteria

(1)Be diagnosed with cancer.
(2)Desire to receive the immune-cell therapy for the treatment of any allergic disease.
(3)Be HIV or HTLV-1 positive.
(4)Be an allotransplant recipient.
(5)Have a history or sign of interstitial pneumonia.
(6)Have an active autoimmune disease.
(7)Be a female who is pregnant, nursing, or of childbearing potential.
(8)A subject 70 years of age and above must be carefully considered for the risk of an autoimmune disease to enroll in this study.
(9)Be determined to be inappropriate by the doctor in charge.

Related Information

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