NCT06940804

A Clinical Study Investigating the Therapeutic Effects and Safety of an Investigational Cell Therapy Given With and Without an Additional Investigational Product in Males With Testicular Cancer or a Form of Cancer That Developed From Sperm

Open-label Phase II Trial to Evaluate Anti-tumor Activity and Safety of CLDN6 CAR-T ± CLDN6 RNA-LPX in Male Participants With Relapsed or Refractory Claudin 6-positive Testicular or Extragonadal Germ Cell Tumors

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will consist of two parts. The Safety Lead-in Part will evaluate safety and tolerability of CLDN6 CAR T ± CLDN6 RNA-LPX therapy in three arms with different dosing regimens. In the Safety Lead-in Part, participants will be randomized in a 1:1:1 ratio. Data from the Safety Lead-in Part up to the cut off will be used to select the dose for the single-arm Main Part of the study. To increase the potency of the transferred CAR-T cells, a lymphodepleting chemotherapy regimen (comprising fludarabine and cyclophosphamide) will be administered in participants prior to infusion of CLDN6 CAR-T. It is expected that it will take approximately 28 months for each participant to complete screening, apheresis, pre-treatment, treatment, and primary follow-up. Participants who receive a CLDN6 CAR-T infusion will complete the long-term follow-up (LTFU) to assess safety and efficacy of the CLDN6 CAR-T treatment for a total of 15 years after CLDN6 CAR-T infusion. No investigational medicinal product (IMP) will be administered during the LTFU.

Conditions

• Testicular Germ Cell Tumor
• Extragonadal Germ Cell Tumor

Interventions

Type	Name	Description
BIOLOGICAL	CLDN6 CAR-T	Intravenous (IV) infusion
BIOLOGICAL	CLDN6 RNA-LPX	IV injection

Timeline

• Start date: 2025-07-01
• Primary completion: 2042-06-01
• Completion: 2042-06-01
• First posted: 2025-04-23
• Last updated: 2025-07-02

Regulatory

• FDA-regulated drug study