Clinical trial • Phase I • Haematology|Immunology
Suicide gene-transduced cytotoxic T cell clone targeting HLA-DPB1*04:01 for Hematological malignancies (post-allogeneic hematopoietic stem cell transplant; HLA-DPB1*04:01 positive)
Phase I trial of Suicide gene-transduced cytotoxic T cell clone targeting HLA-DPB1*04:01 for Hematological malignancies (post-allogeneic hematopoietic ste…
Overview
- Trial Therapeutic Area
- Haematology|Immunology
- Trial Disease
- Hematological malignancies (post-allogeneic hematopoietic stem cell transplant; HLA-DPB1*04:01 positive)
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 26-08-2024
- First CTIS Authorization Date
- 05-09-2024
Trial design
adaptive Phase I trial across 1 site in France.
- Adaptive
- True, dose-escalation design; no further adaptive details provided in source
- Biomarker Stratified
- True, biomarker: HLA-DPB1*04:01 (enrolment limited to HLA-DPB1*04:01 positive patients)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 6
Recruitment
- Planned Sample Size
- 6
- Recruitment Window Months
- 96
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 6
France
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 12-09-2025
- Processing Time Days
- 378
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hematology
- Principal Investigator Name
- Thierry GUILLAUME
- Principal Investigator Email
- thierry.guillaume@chu-nantes.fr
- Contact Person Name
- Thierry GUILLAUME
- Contact Person Email
- thierry.guillaume@chu-nantes.fr
- Number Of Participants
- 6
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Nantes
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Third-party suicide gene-transduced anti-HLA-DPB1*04:01 cytotoxic T cell clone (infusion)
- Active Substance
- Suicide gene-transduced cytotoxic T cell clone targeting HLA-DPB1*04:01
- Modality
- Cell therapy
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous
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