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A study for the safety of NKT cell therapy using alpha-galactosylceramide-pulesed dendritic cells for malignant tumors (NKT cell therapy using alphaGC-DCs for malignant tumors)

NKT cell therapy for malignant tumors (NKT therapy for malignant tumors)

Goto Shigenori

May. 18, 2023

3

Three patients who sought immune-cell therapy in Seta Clinic Tokyo were enrolled. The group comprised two males (aged 69 and 47, respectively) with pancreace cancer, and one female (aged 37) with breast cancer.

All patients successfully completed the treatment protocol, which involved four injections of immune-cell therapy.

Fatigue: 3 cases in 18 injections Details are in the attached sheet

The primary endpoint was the safety of the therapy. Out of 18 injections, only three adverse events related to immune-cell therapy were recorded. All three patients who experienced these events completed the protocol treatment. If there were surplus cells available, each patient had the option to receive up to two additional injections after the protocol treatment. All three patients received these additional injections, bringing the total number of injections to 18. The treatment was performed safely, with only three instances of Grade 1 fatigue, which subsided within one to two days. The secondary endpoint was the efficacy of the therapy. Imaging evaluation was performed on three patients, one of whom showed a partial response (pancreas cancer), while the other two showed stable disease (pancreas cancer and breast cancer). Tumor markers were also measured before and after treatment, with two pancreas cancer patients remaining stable and one breast cancer patient showing a slight increase.

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.

June. 30, 2023

https://jrct.mhlw.go.jp/latest-detail/jRCTc030220374

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 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

Both

malignant tumor

blood collection for cell culture and tests.
Administration of therapeutic cells 4 times.

Safety

Efficacy, Immunological response

Complete

+81-3-5244-5751

Sept. 26, 2022