Stopped: Sponsor decision
This study is designed to evaluate the safety, efficacy, cellular kinetics, and immunogenicity of Claudin 6 (CLDN6) Chimeric antigen receptor T cell (CAR-T) ± CLDN6 ribonucleic acid-lipoplex (RNA-LPX) in participants born male with relapsed or refractory CLDN6-positive testicular or extragonadal germ cell tumors (GCTs) after prior salvage therapy.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety Lead-in Part: Occurrence of treatment emergent adverse events (TEAEs) including Grade ≥3, adverse events of special interest (AESIs) and serious or fatal TEAEs by casual relationship to study treatment
Timeframe: Up to 110 weeks after first dose of IMP
Main Part: Overall response rate (ORR) assessed by the blinded independent central review (BICR)
Timeframe: Up to 110 weeks after first dose of IMP
LTFU: Occurrence of AEs suspected to be related to CLDN6 CAR-T
Timeframe: Up to 15 years after CLDN6 CAR-T administration