Clinical trial • Phase I/II • Oncology
LETETRESGENE AUTOLEUCEL for Non-small cell lung cancer | Synovial sarcoma | Multiple myeloma | Myxoid/round cell liposarcoma (MRCLS)
Phase I/II trial of LETETRESGENE AUTOLEUCEL for Non-small cell lung cancer | Synovial sarcoma | Multiple myeloma | Myxoid/round cell liposarcoma (MRCLS).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Synovial sarcoma | Multiple myeloma | Myxoid/round cell liposarcoma (MRCLS)
- Trial Stage
- Phase I/II
- Drug Modality
- Cell therapy | Gene therapy
Key dates
- Initial CTIS Submission Date
- 12-06-2024
- First CTIS Authorization Date
- 11-07-2024
Trial design
Phase I/II trial across 3 sites in Italy, Netherlands, Spain.
- Target Sample Size
- 66
- Trial Duration For Participant
- 4187
Eligibility
Recruits 66 Vulnerable population selected (isVulnerablePopulationSelected = true). Eligibility requires participants to be "Capable of giving signed informed consent." No further details on assent or surrogate consent are provided in the record..
- Pregnancy Exclusion
- 4. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Eligibility requires participants to be "Capable of giving signed informed consent." No further details on assent or surrogate consent are provided in the record.
Inclusion criteria
- {"criterion_text":"- 1. Participants who have received at least one dose of ADP adoptive cell therapy agent."}
- {"criterion_text":"- 2. Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it."}
- {"criterion_text":"- 3. Participants who have completed treatment as part of managed access to an adoptive cell therapy."}
- {"criterion_text":"- 4. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies."}
- {"criterion_text":"- 5. The investigator is responsible for review of medical history."}
- {"criterion_text":"- 6. Capable of giving signed informed consent."}
Exclusion criteria
- {"criterion_text":"- None"}
Endpoints
Primary endpoints
- {"endpoint_text":"- AEs/SAEs to be reported: New malignancies","definition_or_measurement_approach":""}
- {"endpoint_text":"- AEs/SAEs to be reported: New incidence or exacerbation of a pre-existing neurologic disorder","definition_or_measurement_approach":""}
- {"endpoint_text":"- AEs/SAEs to be reported: New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder","definition_or_measurement_approach":""}
- {"endpoint_text":"- AEs/SAEs to be reported: New incidence of hematologic disorder","definition_or_measurement_approach":""}
- {"endpoint_text":"- AEs/SAEs to be reported: New incidence of infection (potentially related to gene modified cell therapy)","definition_or_measurement_approach":""}
- {"endpoint_text":"- AEs/SAEs to be reported: Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Vesicular Stomatitis Virus G protein (VSV-G) deoxyribonucleic acid (DNA) copies in peripheral blood samples.","definition_or_measurement_approach":"Measured as VSV-G DNA copies in peripheral blood samples."}
- {"endpoint_text":"- Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples","definition_or_measurement_approach":"Measured as WPRE or Psi DNA copies in peripheral blood samples."}
- {"endpoint_text":"- Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) identified in peripheral blood","definition_or_measurement_approach":"Assessed by analysis of integrated vector sequences and integration pattern characterization in peripheral blood samples."}
- {"endpoint_text":"- Incidence of death and time to death","definition_or_measurement_approach":"Recorded as incidence and time-to-event (death) based on survival status monitoring."}
Recruitment
- Planned Sample Size
- 66
- Recruitment Window Months
- 137
- Consent Approach
- Participants must be capable of giving signed informed consent ("Capable of giving signed informed consent."). Subject information and informed consent forms are available in Italian, Dutch and Spanish (documents: L1_IT_SIS-ICF_Main_Italian_redacted; L1_NL_SIS-ICF_Main_Dutch_redacted; L1_ES_SIS-ICF_Main_Spanish_redacted). No details on assent for minors are provided.
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 5
Italy
- Earliest CTIS Part Ii Submission Date
- 09-07-2024
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 659
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Silvia Stacchiotti
- Principal Investigator Email
- Silvia.Stacchiotti@istitutotumori.mi.it
- Contact Person Name
- Silvia Stacchiotti
- Contact Person Email
- Silvia.Stacchiotti@istitutotumori.mi.it
- Number Of Participants
- 2
Netherlands
- Earliest CTIS Part Ii Submission Date
- 09-07-2024
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 668
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Division of Medical Oncology, Division of Molecular Oncology & Immunology
- Principal Investigator Name
- John Haanen
- Principal Investigator Email
- j.haanen@nki.nl
- Contact Person Name
- John Haanen
- Contact Person Email
- j.haanen@nki.nl
- Number Of Participants
- 1
Spain
- Earliest CTIS Part Ii Submission Date
- 09-07-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 654
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Medical Oncology Service
- Principal Investigator Name
- Maria Pilar Sancho
- Principal Investigator Email
- mariap.sancho.sspa@juntadeandalucia.es
- Contact Person Name
- Maria Pilar Sancho
- Contact Person Email
- mariap.sancho.sspa@juntadeandalucia.es
- Number Of Participants
- 2
Sponsor
Primary sponsor
- Full Name
- USWM Ct LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Collection and entry of local lab data; other responsibilities listed with codes 1,11,5,6,7
Third parties
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Patient reported outcomes","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image analysis/review - X-ray, MRI, urltrasound","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central lab (kit supplier, sample storage & management)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Collection and entry of local lab data; other duties listed with codes 1,11,5,6,7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Transgene persistence and RCL testing for PK and safety; remaining samples storage","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"XEVMPD; other duties (code 8)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- GSK3377794
- Active Substance
- LETETRESGENE AUTOLEUCEL
- Modality
- Cell therapy | Gene therapy
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Investigational medicinal product (Advanced Therapy IMP/ATIMP)
- Maximum Dose
- 15.00 billion organisms
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