MedPath

2DG-abT therapy for malignant tumors

Phase 1
Conditions
malignant tumor
Registration Number
JPRN-jRCTc030210184
Lead Sponsor
Takimoto Rishu
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
3
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath