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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

NCT06940804 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

  • Testicular Germ Cell Tumor
  • Extragonadal Germ Cell Tumor

Interventions

BIOLOGICAL

CLDN6 CAR-T

Intravenous (IV) infusion

BIOLOGICAL

CLDN6 RNA-LPX

IV injection

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2042-06-30
Completion
2042-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06940804 on ClinicalTrials.gov