Clinical trial • Phase I • Oncology|Haematology
Genetically modified T lymphocytes secreting αCD19xαCD3 bispecific antibodies for Malignant B-cell neoplasms|B-cell non-Hodgkin lymphoma|Acute lymphoblastic leukemia|Acute lymphoblastic leukemia refractory
Phase I trial of Genetically modified T lymphocytes secreting αCD19xαCD3 bispecific antibodies for Malignant B-cell neoplasms|B-cell non-Hodgkin lymphoma|…
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- Malignant B-cell neoplasms|B-cell non-Hodgkin lymphoma|Acute lymphoblastic leukemia|Acute lymphoblastic leukemia refractory
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy|Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 31-12-2025
- First CTIS Authorization Date
- 22-04-2026
Trial design
Phase I trial across 4 sites in Spain.
- Target Sample Size
- 24
Eligibility
Recruits 24 Vulnerable population selected in trial record (isVulnerablePopulationSelected = true). No further details on specific vulnerable groups, consent or assent procedures are provided in the available CTIS data..
- Vulnerable Population
- Vulnerable population selected in trial record (isVulnerablePopulationSelected = true). No further details on specific vulnerable groups, consent or assent procedures are provided in the available CTIS data.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 24
Spain
- Earliest CTIS Part Ii Submission Date
- 15-04-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 7
- Number Of Sites
- 4
- Number Of Participants
- 24
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Haematology
- Contact Person Name
- Tycho Baumann
- Contact Person Email
- tychostephan.baumann@salud.madrid.org
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Haematology
- Contact Person Name
- Pilar Lloret
- Contact Person Email
- pilar_lloret@iislafe.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Haematology
- Contact Person Name
- Anna Torrents
- Contact Person Email
- atorrent@iconcologia.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Haematology
- Contact Person Name
- Valentín Ortiz Maldonado
- Contact Person Email
- VORTIZ@clinic.cat
Sponsor
Primary sponsor
- Full Name
- Fundacion Para La Investigacion Biomédica Del Hospital Universitario 12 De Octubre
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- STAb-T19 cells
- Active Substance
- Genetically modified T lymphocytes secreting αCD19xαCD3 bispecific antibodies
- Modality
- Cell therapy
- Routes Of Administration
- Infusion (intravenous)
- Route
- Intravenous
- First In Human
- Yes
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