JPRN-jRCTc030210184CompletedPhase 1
A clinical study on the safety of 2DG-abT cell therapy for malignant tumor.
Takimoto Rishu0 sites3 target enrollmentStarted: July 5, 2021Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 3
Study Overview
Brief Summary
A total of three patients with malignant tumors were enrolled in this clinical study from December 2021 to August 2022.2. Of the three enrolled patients, two completed protocol treatment (2DG-abTx 3 injections) and one discontinued study treatment for patient convenience after two injections. The primary endpoint (safety) showed no adverse events due to cell therapy. 2DG-abT treatment could be safely administered.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion 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.
Exclusion 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
Investigators
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