As of 5 November 2021 (enrollment of last patient dosed), 180 patients were prescreened and 54 classified as CLDN6-positive (50% of tumor cells 2+ CLDN6 membrane staining). Eighteen patients dropped out before the screening visit due to death ( n = 9), worsening of condition ( n = 7), loss to follow-up ( n = 1) or refusal of participation ( n = 1). Twenty-nine patients underwent full screening for trial eligibility, of which four patients did not meet eligibility criteria. Seven patients remained listed to be screened for trial eligibility, but did not consent for full trial eligibility screening, for example, because of decision to undergo other treatment approaches. CAR-T cell products were manufactured for all 25 enrolled patients. Of those, 22 were treated and included in the safety set, while one patient, who received CAR-T cells at <DL1, was excluded from the efficacy set.
