KT cell therapy for malignant tumors
- Conditions
- malignant tumor
- Registration Number
- JPRN-jRCTc030220374
- Lead Sponsor
- Takimoto Rishu
- Brief Summary
Approval for this clinical study was granted on October 11th, 2022, with all three patients enrolled during the same month. All three completed the protocol treatment (4 injections of immune-cell therapy) safely. If there were surplus cells available, up to two additional infusions can be administered after the protocol treatment, as was the case with all three patients in this study. NKT cell therapy was performed safely.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 3
(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 at age 18 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 agreement of the attending doctor to participate in this study.
(7) Provide written consent to participate this study.
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Efficacy, Immunological response