PB103 is allogeneic NK cells derived from a healthy donor. In this phase I/IIa trial, patients with IIIb/IV and refractory non-small cell lung cancer will be enrolled for testing the safety, tolerability, and efficacy of PB103 (NK cells). For assessment of safety and maximum tolerated dose (MTD) of PB103, three-dose levels of PB103 will be administered to enrolled patients based on the 3+3 dose-escalation design. MTD is deﬁned as one dose level below the dose at which dose-limiting toxicities (DLT) is observed in <33% of the participants. DLT is deﬁned as grade 4 toxicities (hematological toxicities), grade 3 toxicities (non-hematological toxicities), or acute GvHD more than grade 2. Once MTD is determined, 12 patients at MTD dose will be enrolled for assessment of safety and efficacy of PB103 at phase IIa.
Objectives: To determine the safety, tolerability, and efficacy of allogeneic PB103 in patients with IIIb/IV or refractory non-small-cell lung cancer