definiens: means a human clinical trial of a compound, the principal purpose of which is afurther determination of safety and pharmacokinetics of the compound whether or not in combination with concomitanttreatment after an initial Phase 1a Clinical Trial, prior to commencement of Phase 2 Clinical Trials or Phase 3 ClinicalTrials, and which provides ( itself or together with other available data ) sufficient evidence of safety to be included infilings for a Phase 2 Clinical Trial or a Phase 3 Clinical Trial with Regulatory Authorities, or a similar clinical studyprescribed by the Regulatory Authorities in a foreign country For studies of CAR / TCR agents, a Phase 1b Clinical Trialmay include assessments of the expansion and persistence of the transferred T - Cells, immunological behavior of thetransferred cells and evidence of clinical activity based on cellular, molecular and/or radiographic evidence of anti - tumor response