NCT06940804 (AVENTURINE) is a Phase 2 clinical trial of CLDN6 CAR-T in Testicular Germ Cell Tumor, sponsored by BioNTech SE.

Who is sponsoring NCT06940804?

NCT06940804 is sponsored by BioNTech SE.

What drugs are being tested in NCT06940804?

Interventions in NCT06940804: CLDN6 CAR-T, CLDN6 RNA-LPX.

What condition does NCT06940804 study?

NCT06940804 studies Testicular Germ Cell Tumor, Extragonadal Germ Cell Tumor.

Is NCT06940804 still recruiting?

NCT06940804 is currently withdrawn. Last updated 30 June 2025.

Last reviewed 2025-06-30 · How we verify

NCT06940804: AVENTURINE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Withdrawn Phase 2 Last updated 30 June 2025

What this trial tests

Phase 2 trial testing CLDN6 CAR-T in Testicular Germ Cell Tumor. Withdrawn.

Timeline

1 July 2025

Primary endpoint
1 June 2042

1 June 2042

Quick facts

Lead sponsor	BioNTech SE
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Start date	1 July 2025
Primary completion	1 June 2042
Estimated completion	1 June 2042

Drugs / interventions tested

CLDN6 CAR-T — full drug profile →
CLDN6 RNA-LPX — full drug profile →

Conditions studied

Testicular Germ Cell Tumor — all drugs for Testicular Germ Cell Tumor →
Extragonadal Germ Cell Tumor — all drugs for Extragonadal Germ Cell Tumor →

Sponsor

BioNTech SE — full company profile →

Who can join

18 and older, male only, with Testicular Germ Cell Tumor or Extragonadal Germ Cell Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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
Time frame: Up to 110 weeks after first dose of IMP
For each treatment arm
Main Part: Overall response rate (ORR) assessed by the blinded independent central review (BICR)
Time frame: Up to 110 weeks after first dose of IMP
Defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) (per response evaluation criteria in solid tumors version 1.1 (\[RECIST 1.1\]) is observed as best overall response
LTFU: Occurrence of AEs suspected to be related to CLDN6 CAR-T
Time frame: Up to 15 years after CLDN6 CAR-T administration
AEs may include: new malignancy (hematologic or solid) from genetically modified cells; new neurologic disorder, or exacerbation of a pre-existing disorder; new rheumatologic or autoimmune disorder, or exacerbation of a prior rheumatologic or other autoimmune disorder; new hematologic disorder; other new clinical condition considered by the investigator to be related to the prior genetically engin

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Testicular Germ Cell Tumor

Currently open trials in the same condition.

NCT07453082 — A Prospective Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumors · recruiting

Other BioNTech SE trials

Trials by the same sponsor.

NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
NCT07069309 — A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 1 · Phase 3 · active not recruiting
NCT06821061 — A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People · Phase 1, PHASE2 · completed
NCT05630352 — A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children · Phase 1 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06940804 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioNTech SE
Last refreshed: 30 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06940804.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing