臨床研究等提出・公開システム

A clinical study on the safety of 2DG-abT cell therapy for malignant tumor.

2DG-abT therapy for malignant tumors

Goto Shigenori

Mar. 20, 2023

3

The 3 enrolled patients consisted of 2 females (66 years old: ovarian cancer, 56 years old: sigmoid colon cancer) and 1 male (43 years old: multiple glioma).

Of the 3 enrolled patients, 2 completed the protocol treatment (immune cell therapy x3 injectionss) and 1 patient discontinued the treatment for his own reasons after 2 injections.

No adverse events related to 2DG-abT were observed.

The primary endpoint (safety) showed no adverse events due to cell therapy. In the secondary endpoint (efficacy), two patients with imaging evaluation had PD and one patient with glioma multiforme discontinued study treatment due to worsening disease.

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.

April. 28, 2023

https://jrct.mhlw.go.jp/latest-detail/jRCTc030210184

Takimoto Rishu

Koshikai, Non-profit Medical Corporation

3F New Surugadai Bld. 2-1-45 Kanda-Surugadai, Chiyoda-ku Tokyo.

info@j-immunother.com

Oguma Eri

Koshikai, Non-profit Medical Corporation

3F New Surugadai Bld. 2-1-45 Kanda-Surugadai, Chiyoda-ku Tokyo.

+81-3-5244-5751

citeg@j-immunother.com

Interventional

single arm study

open(masking not used)

no treatment control

single assignment

treatment purpose

(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.

(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

Both

malignant tumor

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

Safety

Efficacy, Immunological response

Complete

+81-3-5244-5751

May. 24, 2021