Clinical trial • Phase I • Oncology
p95HER2 CAR-T cells (autologous) for Breast cancer | Gastric cancer | Endometrial cancer | HER2-positive solid tumors
Phase I trial of p95HER2 CAR-T cells (autologous) for Breast cancer | Gastric cancer | Endometrial cancer | HER2-positive solid tumors.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Breast cancer | Gastric cancer | Endometrial cancer | HER2-positive solid tumors
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 07-08-2024
- First CTIS Authorization Date
- 13-01-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 2 sites in Spain.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True - dose-escalation design; specific escalation rules, interim analyses and stopping rules not provided in available documents.
- Biomarker Stratified
- True, biomarker: HER-2 (3+)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 15
Eligibility
Recruits 15 Vulnerable populations selected; specific consent/assent handling not provided in available documents..
- Vulnerable Population
- Vulnerable populations selected; specific consent/assent handling not provided in available documents.
Recruitment
- Planned Sample Size
- 15
- Recruitment Window Months
- 41
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 15
Spain
- Earliest CTIS Part Ii Submission Date
- 16-09-2024
- Latest Decision Or Authorization Date
- 13-01-2025
- Processing Time Days
- 119
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología Médica
- Contact Person Name
- Irene Braña
- Contact Person Email
- ibrana@vhio.net
- Site Name
- Hospital Del Mar
- Department Name
- Oncología Médica
- Contact Person Name
- Joan Albanell
- Contact Person Email
- jalbanell@psmar.cat
Sponsor
Primary sponsor
- Full Name
- Vall D Hebron Institute Of Oncology
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Autologous p95HER2.CAR-TECH2Me T Cells
- Active Substance
- p95HER2 CAR-T cells (autologous)
- Modality
- Cell therapy
- Authorisation Status
- Not authorised
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