Clinical trial • Phase I • Oncology
Genetically modified T-cells (ROR1-targeted) for Adrenocortical carcinoma | Breast cancer | Chronic lymphocytic leukemia | Ovarian cancer | Mantle cell lymphoma
Phase I trial of Genetically modified T-cells (ROR1-targeted) for Adrenocortical carcinoma | Breast cancer | Chronic lymphocytic leukemia | Ovarian cancer…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Adrenocortical carcinoma | Breast cancer | Chronic lymphocytic leukemia | Ovarian cancer | Mantle cell lymphoma
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 11-06-2024
- First CTIS Authorization Date
- 19-07-2024
Trial design
Phase I trial across 3 sites in Germany.
- Target Sample Size
- 44
Eligibility
Recruits 44 Vulnerable population selected; no details on consent or assent provided in the record..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent provided in the record.
Recruitment
- Planned Sample Size
- 44
- Recruitment Window Months
- 215
- Consent Approach
- No information on informed consent or assent process provided in the record.
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 44
Germany
- Earliest CTIS Part Ii Submission Date
- 16-05-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 697
- Number Of Sites
- 3
- Number Of Participants
- 44
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- CBF, Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie, ECTU
- Principal Investigator Name
- Marie Luise Hütter-Krönke
- Principal Investigator Email
- luise.huetter-kroenke@charite.de
- Contact Person Name
- Marie Luise Hütter-Krönke
- Contact Person Email
- luise.huetter-kroenke@charite.de
- Site Name
- Universitaetsklinikum Koeln AöR
- Department Name
- Klinik I für Innere Medizin
- Principal Investigator Name
- Ron Jachimowicz
- Principal Investigator Email
- ron.jachimowicz@uk-koeln.de
- Contact Person Name
- Ron Jachimowicz
- Contact Person Email
- ron.jachimowicz@uk-koeln.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik und Poliklinik II, Interdisziplinäres Studienzentrum mit ECTU
- Principal Investigator Name
- Hermann Einsele
- Principal Investigator Email
- einsele_h@ukw.de
- Contact Person Name
- Hermann Einsele
- Contact Person Email
- einsele_h@ukw.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Wuerzburg AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Genetically modified T-cells (ROR1-targeted)
- Modality
- Cell therapy
- First In Human
- Yes
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