AzTrials
AzTrials

Testicular Germ Cell TumorPhase 2AVENTURINENCT06940804

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

A Phase 2 study testing CLDN6 CAR-T and CLDN6 RNA-LPX in people with Testicular Germ Cell Tumor and Extragonadal Germ Cell Tumor, run by BioNTech SE.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
CLDN6 CAR-T and CLDN6 RNA-LPX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2025to Jun 2042
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a histologically confirmed diagnosis of a testicular or extragonadal GCT of extracranial origin.
  • Evidence of measurable disease by RECIST 1.1 or if RECIST 1.1 evaluation is not possible, elevation of serum tumor marker(s) (AFP or βhCG).
  • Participants with evidence of progressive or recurrent metastatic GCT defined as meeting at least one of the following criteria:
  • Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT. In the event of an incomplete gross resection where viable GCT is found, participants will be considered eligible for this study.
  • Elevated serum tumor markers (AFP or ßhCG) that are increasing. Increase of an elevated lactate dehydrogenase alone does not constitute progressive disease.
  • Development of new or enlarging lesions in the setting of persistently elevated AFP or ßhCG, even if the markers are not continuing to rise.
Show all 10Show fewer
  • Participants must have received prior high-dose chemotherapy with autologous stem cell transplantation or conventional dose chemotherapy as salvage therapy. There is no maximum limit for the number of prior treatments.
  • Have a CLDN6-positive tumor assessed using an analytically validated immunohistochemistry assay at a central laboratory.
  • Have an Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Have laboratory tests of adequate organ function as defined in the protocol.

Who cannot join

  • Had major surgery within the 4 weeks before the first dose of study treatment.
  • Have received a prior CLDN6 CAR-T therapy.
  • Are receiving systemic (oral or IV) steroid therapy >10 mg prednisolone daily, or its equivalent, for an underlying condition.
  • Have unresolved side effects of any prior therapy or procedures not recovered to CTCAE version 5.0 Grade 1 or lower, except for AEs not constituting a safety risk by investigator judgment.
  • Have a pure teratoma, or pure teratoma with somatic-type malignancy or a combination of these histologies without any additional histologic subtype.
  • Have current evidence of active and/or uncontrolled brain or spinal metastases.
Show all 12Show fewer
  • Have an active autoimmune disease or any active immunologic disorder requiring immunosuppression with steroids or other immunosuppressive agents (protocol-defined exceptions apply). Note: Participants may be included if their disease is well controlled without the use of immunosuppressive agents, at the discretion of the investigator.
  • Have a history of another primary cancer within the 24 months prior to signing the main informed consent form (exceptions for definitely treated malignancies that have been in complete remission for more than 24 months apply).
  • Receipt of allogeneic stem cell transplantation in the 5 years prior to study enrollment.
  • Have cardiac conditions defined as exclusionary per protocol.
  • Have any concurrent conditions that could pose an undue medical hazard or interfere with the interpretation of the study results.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

About this study

Official title: 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

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.

Read the 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.

Being tested
CLDN6 CAR-T, CLDN6 RNA-LPX
Keywords
Advanced germ cell tumor, Metastatic germ cell tumors, CLDN6-positive relapsed or refractory advanced solid tumors, Salvage therapy, Testicular cancer, Immunotherapy, Autologous T-cells
Medical subject headings
Testicular Germ Cell Tumor, Neoplasms, Germ Cell and Embryonal, Testicular Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLDN6 CAR-TBiological

    Intravenous (IV) infusion

  • CLDN6 RNA-LPXBiological

    IV injection

Study groups in NCT06940804
Study groupRoleWhat they receive
Safety Lead-in Part - CLDN6 CAR-T (dose level 1) + CLDN6 RNA-LPXExperimentalNot described
Receives: Biological: CLDN6 CAR-T; Biological: CLDN6 RNA-LPX
Safety Lead-in Part - CLDN6 CAR-T (dose level 2)ExperimentalNot described
Receives: Biological: CLDN6 CAR-T
Safety Lead-in Part - CLDN6 CAR-T (dose level 2) + CLDN6 RNA-LPXExperimentalNot described
Receives: Biological: CLDN6 CAR-T; Biological: CLDN6 RNA-LPX
Main Part - Selected dose of CLDN6 CAR-T + CLDN6 RNA-LPXExperimentalDoses as selected from the Safety Lead-in Part
Receives: Biological: CLDN6 CAR-T; Biological: CLDN6 RNA-LPX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    For each treatment arm

    Measured: Up to 110 weeks after first dose of IMP

  2. Main Part: Overall response rate (ORR) assessed by the blinded independent central review (BICR)

    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

    Measured: Up to 110 weeks after first dose of IMP

  3. LTFU: Occurrence of AEs suspected to be related to CLDN6 CAR-T

    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 engineered T-cell therapy.

    Measured: Up to 15 years after CLDN6 CAR-T administration

Secondary outcomes (18)

  1. Safety Lead-in and Main Part: Occurrence of TEAEs including Grade ≥3, AESIs, and serious or fatal TEAEs by casual relationship to study treatment

    For each treatment arm

    Measured: From first dose of IMP until 90 days after last dose of IMP, or until a new anticancer therapy is started, whichever occurs first

  2. Safety Lead-in and Main Part: Geometric mean of pharmacokinetic parameter maximum concentration (Cmax) of CLND6 CAR-T

    For each treatment arm using CLND6 CAR-T concentration in blood

    Measured: Up to 97 weeks after first IMP dose

  3. Main Part: Geometric mean of pharmacokinetic parameter Cmax of interleukin (IL)-6

    From baseline until last available sample

    Measured: Up to 97 weeks after first IMP dose

  4. Safety Lead-in and Main Part: Geometric mean of pharmacokinetic parameter time to maximum concentration (Tmax) of CLND6 CAR-T

    For each treatment arm using CLND6 CAR-T concentration in blood

    Measured: Up to 97 weeks after first IMP dose

  5. Main Part: Geometric mean of pharmacokinetic parameter Tmax of IL-6

    From baseline until last available sample

    Measured: Up to 97 weeks after first IMP dose

  6. Safety Lead-in and Main Part: Geometric mean of pharmacokinetic parameter area under the time concentration curve (AUC) of CLND6 CAR-T

    For each treatment arm using CLND6 CAR-T concentration in blood

    Measured: Up to 97 weeks after first IMP dose

  7. Safety Lead-in and Main Part: Overall response rate (ORR) assessed by the investigator

    Defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. Tumor response will be assessed by the investigator per RECIST 1.1. In the Safety Lead-in Part, tumor assessment will also be made based on reduction of the serum tumor marker(s) (alpha fetoprotein [AFP]/beta human chorionic gonadotropin [βhCG]).

    Measured: Up to 110 weeks after first dose of IMP

  8. Safety Lead-in and Main Part: Disease control rate (DCR) assessed by the investigator

    Defined as the percentage of participants in whom a CR, PR, or stable disease (SD) is observed as best overall response. Tumor response will be assessed per RECIST 1.1. In the Safety Lead-in Part, tumor assessment will also be made based on reduction of the serum tumor marker(s) (alpha fetoprotein [AFP]/beta human chorionic gonadotropin [βhCG]).

    Measured: Up to 110 weeks after first dose of IMP

  9. Main Part: DCR assessed by BICR

    Defined as the percentage of participants in whom a CR, PR, or SD is observed as best overall response. Tumor response will be assessed per RECIST 1.1

    Measured: Up to 110 weeks after first dose of IMP

  10. Main Part: Progression-free survival (PFS) assessed by the investigator

    Defined as the time from first dose of CLDN6 CAR-T to progressive disease (PD) or death from any cause, whichever occurs first. Tumor response will be assessed per RECIST 1.1

    Measured: Up to 110 weeks after first dose of IMP

  11. Main Part: PFS assessed by BICR

    Defined as the time from first dose of CLDN6 CAR-T to PD or death from any cause, whichever occurs first. Tumor response will be assessed per RECIST 1.1

    Measured: Up to 110 weeks after first dose of IMP

  12. LTFU: PFS assessed by the investigator

    Defined as the time from first dose of CLDN6 CAR-T to first objective progressive disease per RECIST 1.1 and/or based on reduction of the serum tumor marker(s) (AFP/βhCG), or death from any cause, whichever occurs first.

    Measured: Up to 15 years after the last IMP administration

  13. Main Part: Duration of response (DOR) assessed by the investigator

    Defined as the time from first objective response (CR or PR) to first occurrence of tumor progression, or death from any cause, whichever occurs first. Tumor response will be assessed per RECIST 1.1.

    Measured: Up to 110 weeks after first dose of IMP

  14. Main Part: DOR assessed by BICR

    Defined as the time from first objective response (CR or PR) to first occurrence of tumor progression, or death from any cause, whichever occurs first. Tumor response will be assessed per RECIST 1.1.

    Measured: Up to 110 weeks after first dose of IMP

  15. Main Part: Overall survival (OS)

    Defined as the time from first dose of CLDN6 CAR-T to death from any cause

    Measured: Up to 97 weeks after first dose of IMP or until death, whichever occurs first

  16. LTFU: OS

    Defined as the time from first dose of CLDN6 CAR-T to death from any cause

    Measured: Up to 15 years from last genetically engineered T-cell infusion or until death, whichever occurs first

  17. Main Part: Percentage of participants with pre-existing anti-chimeric antigen receptor (CAR) antibodies prior to CLDN6 CAR-T infusion

    For each treatment arm using CLND6 CAR-T concentration in blood and of IL-6 from baseline until last available sample

    Measured: On Day 1 prior to CAR-T infusion

  18. Main Part: Percentage of participants with treatment-emergent anti-CAR antibodies post-CLDN6 CAR-T infusion until last available sample

    Anti-CAR antibodies including both treatment-induced and treatment-boosted

    Measured: Up to 97 weeks after first dose of IMP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionJun 2042 (estimated)
  4. Study completionJun 2042 (estimated)

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06940804
Sponsor's protocol ID
BNT211-02
Other IDs
2024-511941-20-00
Acronym
AVENTURINE
Status last verified
Jun 2025
First submitted
16 Apr 2025
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CLDN6 CAR-T and CLDN6 RNA-LPX in people with Testicular Germ Cell Tumor and Extragonadal Germ Cell Tumor, run by BioNTech SE.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06940804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in