Clinical trial • Phase I • Oncology|Haematology
CART123 (CD123-targeted autologous CAR T cells) for CD123-positive hematological malignancies|Acute myeloid leukemia|Myelodysplastic syndrome|Blastic plasmacytoid dendritic cell neoplasm|Acute lymphoblastic leukemia
Phase I trial of CART123 (CD123-targeted autologous CAR T cells) for CD123-positive hematological malignancies|Acute myeloid leukemia|Myelodysplastic synd…
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- CD123-positive hematological malignancies|Acute myeloid leukemia|Myelodysplastic syndrome|Blastic plasmacytoid dendritic cell neoplasm|Acute lymphoblastic leukemia
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 30-05-2024
- First CTIS Authorization Date
- 05-09-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 1 site in Czechia.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation design (increasing dose) indicated in trial description
- Biomarker Stratified
- True, biomarker: CD123
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 18
Eligibility
Recruits 18 Vulnerable population selected; no details on consent or assent handling available in the provided documents..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling available in the provided documents.
Recruitment
- Planned Sample Size
- 18
- Recruitment Window Months
- 50
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 18
Czechia
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 05-09-2024
- Processing Time Days
- 34
- Number Of Sites
- 1
- Number Of Participants
- 18
Sites
- Site Name
- Institute Of Hematology And Blood Transfusion
- Department Name
- JIHeP
- Contact Person Name
- Jan Vydra
- Contact Person Email
- jan.vydra@uhkt.cz
- Number Of Participants
- 18
Sponsor
Primary sponsor
- Full Name
- Institute Of Hematology And Blood Transfusion
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Czechia
Investigational products
- Investigational Product Name
- CAR123 T cell
- Active Substance
- CART123 (CD123-targeted autologous CAR T cells)
- Modality
- Cell therapy
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