Who is sponsoring NCT02661685?

NCT02661685 is sponsored by National Defense Medical Center, Taiwan.

What condition does NCT02661685 study?

NCT02661685 studies Neoplasm Metastasis.

Interventions: autologous IKDC-like cells.

NCT02661685 is currently COMPLETED.

Last reviewed 2021-02-17 · How we verify

NCT02661685 Phase 1 COMPLETED

The purpose of this study is to determine the safety of adoptive transferring autologous IKDC-like cells

Lead sponsor	National Defense Medical Center, Taiwan
Phase	Phase 1
Status	COMPLETED
Enrolment	6
Start date	2016-05
Completion	2019-10

Evaluation of subject with Grade 3 or above adverse events that received autologous IKDC-like cells, graded according to NCI-CTCAE v4.03 — Through study complete, an average about 1.5 years
I. Safety is evaluated by assessment of does-limiting toxicity (DLT) according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 or above. II. DLT is defined as follows: * Any Grade 3 or above toxicity regarding general disorders or immune disorders defined by NCI-CTCAE is determined by the investigator to be possibly related in causality to the treatment. * Fever, chillness, flu-like symptoms, or infusion-related reactions of grade 3 or more are to be counted as DLT only if they remain at grade 3 or more for more than three days despite of adequate symptomatic medications.. III. The maximum tolerated dose (MTD) of autologous IKDC-like cell will be determined via a 3+3 traditional design.

Taiwan