Clinical trial • Phase I • Oncology|Immunology|Other
ARI-HER2 (HER2BBz CAR-T Cells) for HER2-positive advanced breast cancer|Advanced breast cancer
Phase I trial of ARI-HER2 (HER2BBz CAR-T Cells) for HER2-positive advanced breast cancer|Advanced breast cancer. None/Not specified-controlled, adaptive.
Overview
- Trial Therapeutic Area
- Oncology|Immunology|Other
- Trial Disease
- HER2-positive advanced breast cancer|Advanced breast cancer
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 10-06-2025
Trial design
None/Not specified-controlled, adaptive Phase I trial across 3 sites in Spain.
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation first-in-human design; no further adaptive design details (e.g. dose escalation schema, interim analyses, stopping rules) provided in available documents.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 18
Eligibility
Recruits 18 Vulnerable population selected; no further details on consent or assent provided in the available documents..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent provided in the available documents.
Recruitment
- Planned Sample Size
- 18
- Recruitment Window Months
- 48
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 18
Spain
- Earliest CTIS Part Ii Submission Date
- 18-09-2025
- Latest Decision Or Authorization Date
- 15-10-2025
- Processing Time Days
- 27
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Contact Person Name
- Marta Santisteban
- Contact Person Email
- na@na.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Contact Person Name
- Laura Angelats
- Contact Person Email
- langelats@recerca.clinic.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Eva Ciruelos
- Contact Person Email
- eva.ciruelos@gmail.com
Sponsor
Primary sponsor
- Full Name
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- ARI-HER2 (HER2BBz CAR-T Cells)
- Active Substance
- ARI-HER2 (HER2BBz CAR-T Cells)
- Modality
- Cell therapy
- Authorisation Status
- Not authorised
- First In Human
- Yes
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