Clinical trial • Phase I • Oncology|Haematology
anti-CD19 CAR-T cells for Non-Hodgkin lymphoma|Diffuse large B-cell lymphoma (DLBCL)|High-grade B-cell lymphoma (HGBL)
Phase I trial of anti-CD19 CAR-T cells for Non-Hodgkin lymphoma|Diffuse large B-cell lymphoma (DLBCL)|High-grade B-cell lymphoma (HGBL).
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- Non-Hodgkin lymphoma|Diffuse large B-cell lymphoma (DLBCL)|High-grade B-cell lymphoma (HGBL)
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 28-11-2024
- First CTIS Authorization Date
- 27-03-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 1 site in Poland.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation design (single-center, dose escalation) — specific escalation rules not provided in the available data
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 18
Eligibility
Recruits 18 Vulnerable population selected. A proposed substantial modification to include children (pediatric patients) was not authorised by the Reporting Member State, citing pediatric-specific risks and potential impact on future standard-of-care treatment options; consent/assent handling for vulnerable subjects is not specified in the available data..
- Vulnerable Population
- Vulnerable population selected. A proposed substantial modification to include children (pediatric patients) was not authorised by the Reporting Member State, citing pediatric-specific risks and potential impact on future standard-of-care treatment options; consent/assent handling for vulnerable subjects is not specified in the available data.
Recruitment
- Planned Sample Size
- 18
- Recruitment Window Months
- 30
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 18
Poland
- Earliest CTIS Part Ii Submission Date
- 26-02-2025
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 380
- Number Of Sites
- 1
- Number Of Participants
- 18
Sites
- Site Name
- Wroclaw Medical University
- Department Name
- Department and Clinic of Hematology, Cellular Therapies and Internal Medicine
- Contact Person Name
- Tomasz Wróbel
- Contact Person Email
- tomasz.wrobel@umw.edu.pl
- Number Of Participants
- 18
Sponsor
Primary sponsor
- Full Name
- Wroclaw Medical University
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Poland
Investigational products
- Investigational Product Name
- anti-CD19 CAR-T Cells
- Active Substance
- anti-CD19 CAR-T cells
- Modality
- Cell therapy
- First In Human
- Yes
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