Clinical trial • Phase I/II • Oncology
CLDN6 CAR-T for Solid tumors | Non-small cell lung cancer | Ovarian cancer | Uterine cancer | Gastric cancer | Testicular cancer | Carcinoma of unknown primary
Phase I/II trial of CLDN6 CAR-T for Solid tumors | Non-small cell lung cancer | Ovarian cancer | Uterine cancer | Gastric cancer | Testicular cancer | Car…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Solid tumors | Non-small cell lung cancer | Ovarian cancer | Uterine cancer | Gastric cancer | Testicular cancer | Carcinoma of unknown primary
- Trial Stage
- Phase I/II
- Drug Modality
- Cell therapy | Other RNA
Key dates
- Initial CTIS Submission Date
- 14-06-2024
- First CTIS Authorization Date
- 01-07-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial across 11 sites in Netherlands, Sweden, Germany.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation design with expansion cohorts; MTD/RP2D to be identified based on occurrence of dose-limiting toxicities (DLT) with MTD defined as highest tolerated dose where <33% of patients experience a DLT.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 206
Eligibility
Recruits 206 Vulnerable population selected; no specific description of vulnerable populations or consent/assent procedures is provided in the available trial record..
- Vulnerable Population
- Vulnerable population selected; no specific description of vulnerable populations or consent/assent procedures is provided in the available trial record.
Inclusion criteria
- {"criterion_text":"- Must have a CLDN6-positive tumor regardless of tumor histology defined as ≥50% of tumor cells expressing CLDN6 protein at an intensity of ≥2+ using a semi-quantitative immunohistochemistry (IHC) assay for specific detection of CLDN6 protein expression in formalin-fixed, paraffin-embedded neoplastic tissues.\n- Must have measurable disease per RECIST 1.1 (except for germ cell tumor where patients can be evaluated according to cancer antigen (CA)-125, AFP, or beta human chorionic gonadotropin [βhCG] [as applicable] or ovarian cancer patients where patients can be evaluated according to CA-125. The pre-treatment sample must be at least twice the upper limit of normal [ULN]).\n- Must have a histologically confirmed solid tumor that is metastatic or unresectable and for whom there is no available standard therapy likely to confer clinical benefit, or the patient is not a candidate for such available therapy."}
Exclusion criteria
- {"criterion_text":"- Has received prior CAR-T therapy, except CLDN6 CAR-T therapy.\n- Has received vaccination with live virus vaccines within 6 weeks prior to the start of lymphodepletion (LD).\n- Receives concurrent systemic (oral or i.v.) steroid therapy > 10 mg prednisolone daily, or its equivalent, for an underlying condition.\n- Current evidence of new or growing brain or spinal metastases during screening.\n- Has a history of another primary cancer within the 2 years prior to enrollment except for the following: non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, prostate cancer with currently undetectable prostate specific antigen, or other non-metastatic carcinoma that has been in complete remission without treatment for more than 2 years."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship\n- Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs\n- Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay\n- Objective response rate (ORR) defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per RECIST 1.1 or defined by tumor marker change from baseline when RECIST evaluation is not feasible) is observed as best overall response\n- Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) per RECIST 1.1 or defined by tumor marker change from baseline when RECIST evaluation is not feasible (SD assessed at least 6 weeks after the first dose) is observed as best overall response\n- Duration of response (DOR) defined as the time from first objective response (CR or PR per RECIST 1.1 or first response defined by tumor marker change from baseline when RECIST evaluation is not feasible) to first occurrence of objective PD or death from any cause, whichever occurs first","definition_or_measurement_approach":"Change from baseline in soluble immune factors measured by cytokine multiplex assay; ORR defined as proportion with CR or PR per RECIST 1.1 or defined by tumor marker change when RECIST not feasible; DCR defined as proportion with CR, PR or SD per RECIST 1.1 (SD assessed ≥6 weeks after first dose) or tumor marker change when RECIST not feasible; DOR defined as time from first objective response to objective PD or death."}
Recruitment
- Planned Sample Size
- 206
- Recruitment Window Months
- 249
- Consent Approach
- Informed consent to be obtained using subject information and informed consent forms (multiple ICF documents listed: e.g., L1_SIS-ICF_Main_FP and other versions). The available record lists multiple ICF documents and versions but does not provide specific detail on assent, age-specific consent processes, or languages.
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 206
Netherlands
- Earliest CTIS Part Ii Submission Date
- 06-06-2024
- Latest Decision Or Authorization Date
- 11-11-2025
- Processing Time Days
- 523
- Number Of Sites
- 2
- Number Of Participants
- 55
Sites
- Site Name
- Netherlands Cancer Institute
- Department Name
- Medical Oncology
- Principal Investigator Name
- John Haanen
- Principal Investigator Email
- j.haanen@nki.nl
- Contact Person Name
- John Haanen
- Contact Person Email
- j.haanen@nki.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sander Bins
- Principal Investigator Email
- s.bins@erasmusmc.nl
- Contact Person Name
- Sander Bins
- Contact Person Email
- s.bins@erasmusmc.nl
Sweden
- Earliest CTIS Part Ii Submission Date
- 06-06-2024
- Latest Decision Or Authorization Date
- 11-11-2025
- Processing Time Days
- 523
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Region Stockholm – SLSO
- Department Name
- Centrum för allogen Stamcellstransplantation
- Principal Investigator Name
- Stephan Mielke
- Principal Investigator Email
- stephan.mielke@regionstockholm.se
- Contact Person Name
- Stephan Mielke
- Contact Person Email
- stephan.mielke@regionstockholm.se
Germany
- Earliest CTIS Part Ii Submission Date
- 06-06-2024
- Latest Decision Or Authorization Date
- 13-11-2025
- Processing Time Days
- 525
- Number Of Sites
- 8
- Number Of Participants
- 141
Sites
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Medizinische Klinik 5
- Principal Investigator Name
- Andreas Mackensen
- Principal Investigator Email
- med5-direktion@uk-erlangen.de
- Contact Person Name
- Andreas Mackensen
- Contact Person Email
- med5-direktion@uk-erlangen.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Universitätsmedizin Berlin, Campus Benjamin Franklin
- Principal Investigator Name
- Antonia Busse
- Principal Investigator Email
- antonia.busse@charite.de
- Contact Person Name
- Antonia Busse
- Contact Person Email
- antonia.busse@charite.de
- Site Name
- University Hospital Cologne AöR
- Principal Investigator Name
- Nadine Kutsch
- Principal Investigator Email
- Nadine.kutsch@uk-koeln.de
- Contact Person Name
- Nadine Kutsch
- Contact Person Email
- Nadine.kutsch@uk-koeln.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Principal Investigator Name
- Eva Wagner-Drouet
- Principal Investigator Email
- eva.wagner@unimedizin-mainz.de
- Contact Person Name
- Eva Wagner-Drouet
- Contact Person Email
- eva.wagner@unimedizin-mainz.de
- Site Name
- National Center For Tumor Diseases (NCT) Heidelberg
- Principal Investigator Name
- Guy Ungerechts
- Principal Investigator Email
- guy.ungerechts@nct-heidelberg.de
- Contact Person Name
- Guy Ungerechts
- Contact Person Email
- guy.ungerechts@nct-heidelberg.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- II. Medizinische Klinik
- Principal Investigator Name
- Winfried Henning Alsdorf
- Principal Investigator Email
- w.alsdorf@uke.de
- Contact Person Name
- Winfried Henning Alsdorf
- Contact Person Email
- w.alsdorf@uke.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin III
- Principal Investigator Name
- Daniel Heudobler
- Principal Investigator Email
- daniel.heudobler@ukr.de
- Contact Person Name
- Daniel Heudobler
- Contact Person Email
- daniel.heudobler@ukr.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Hämatologie, Hämaostaseologie,Onkologie und Stammzelltransplantation
- Principal Investigator Name
- Florian Heidel
- Principal Investigator Email
- heidel.florian@mh-hannover.de
- Contact Person Name
- Florian Heidel
- Contact Person Email
- heidel.florian@mh-hannover.de
Sponsor
Primary sponsor
- Full Name
- BioNTech Cell & Gene Therapies GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Icon Public Limited Company
- Responsibilities
- Clinical Research Organization
Third parties
- {"country":"Austria","full_name":"Abf Pharmaceutical Services GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Mlm Medical Labs GmbH","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"RTSM & EDC Support","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"BioKryo GmbH","duties_or_roles":"Sample Storage","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Frigo-Trans GmbH","duties_or_roles":"IMP Storage","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Precision for Medicine GmbH","duties_or_roles":"RTSM & EDC Support","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"ProtaGene CGT GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"Clinical Research Organization","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BNT211 (CLDN6 CAR-T)
- Active Substance
- CLDN6 CAR-T
- Modality
- Cell therapy
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- INTRAVENOUS BOLUS USE
- First In Human
- Yes
- Maximum Dose
- 1000000000 (unit: Other)
- Investigational Product Name
- BNT211 (CLDN6 CAR-T(A))
- Active Substance
- CLDN6 CAR-T(A)
- Modality
- Cell therapy
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- INTRAVENOUS BOLUS USE
- First In Human
- Yes
- Maximum Dose
- 500000000 (unit: Other)
- Investigational Product Name
- BNT211 (CLDN6 RNA-LPX)
- Active Substance
- CLDN6 RNA-LPX
- Modality
- Other RNA
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- INTRAVENOUS BOLUS USE
- First In Human
- Yes
- Maximum Dose
- 200 µg (max daily); max total 3550 µg
- Investigational Product Name
- BNT211 (RBP030.2)
- Active Substance
- RBP030.2
- Modality
- Other RNA
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- INTRAVENOUS BOLUS USE
- First In Human
- Yes
- Maximum Dose
- 100 µg (max daily); max total 1775 µg
- Combination Treatment
- Yes
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