Kyushu University Hospital had received IND clearance from the PMDA for a Phase Ⅰ investigator-initiated clinical trial of GAIA-102 for pediatric cancer patients with recurrent and refractory neuroblastoma (“NB”) or solid pediatric malignancies with pulmonary metastases

GAIA BioMedicine Inc. (“GAIA”), a pioneer in developing innovative immunotherapies, announced that Kyushu University Hospital had received IND clearance from the PMDA for a Phase Ⅰ investigator-initiated clinical trial for pediatric cancer patients with recurrent and refractory neuroblastoma (“NB”) or solid pediatric malignancies with pulmonary metastases. GAIA provides this trial with its leading modality, GAIA-102, NK-cell-like cells.
This trial is a singular-group, non-randomized, open, and uncontrolled study aiming to assess GAIA-102’s safety and determine the recommended dosing frequency.
This is a dose-escalating trial comprised of the GAIA-102 monotherapy cohort and the combination cohort (GAIA-102+Dinutuximab+Filgrastim+Teceleukin). The monotherapy cohort is treated as a basket-type trial, while the combination therapy accommodates only patients with recurrent and refractory NB.
A total of 24 subjects will be treated in Phase Ⅰ (12 for the monotherapy cohort and 12 for the combination therapy cohort), thereby evaluating the safety and determining the recommended dosing frequency.
Phase Ⅰ of this study is subsidized under the Translational Research Program Seeds C(b) of AMED (Japan Agency for Medical Research and Development), and Dr. Naonori Kawakubo (the Department of Pediatric Surgery at Kyushu University, Professor Dr. Tatsuro Tajiri) serves as the principal investigator.

https://www.amed.go.jp/koubo/16/01/1601C_00024.html

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