Clinical trial • Phase I • Haematology
CAP-100 for Chronic lymphocytic leukaemia (CLL) - relapsed/refractory | Small lymphocytic lymphoma (SLL) - relapsed/refractory
Phase I trial of CAP-100 for Chronic lymphocytic leukaemia (CLL) - relapsed/refractory | Small lymphocytic lymphoma (SLL) - relapsed/refractory. adaptive.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Chronic lymphocytic leukaemia (CLL) - relapsed/refractory | Small lymphocytic lymphoma (SLL) - relapsed/refractory
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 21-08-2024
- First CTIS Authorization Date
- 27-08-2024
Trial design
adaptive Phase I trial across 3 sites in Spain.
- Adaptive
- True, dose-escalation followed by dose-expansion as described in the public title; no further adaptive design details provided.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 14
Eligibility
Recruits 14 No vulnerable populations selected; no information on consent/assent handling provided..
- Vulnerable Population
- No vulnerable populations selected; no information on consent/assent handling provided.
Recruitment
- Planned Sample Size
- 14
- Recruitment Window Months
- 51
- Consent Approach
- No information provided on informed consent or assent; vulnerable populations not selected.
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 11
Spain
- Earliest CTIS Part Ii Submission Date
- 19-07-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 661
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Hematology
- Contact Person Name
- Javier Loscertales
- Contact Person Email
- jloscertales@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Hematology
- Contact Person Name
- Adrian Mosquera
- Contact Person Email
- Adrian.Mosquera.Orgeira@sergas.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Hematology
- Contact Person Name
- Lucrecia Yáñez San Segundo
- Contact Person Email
- lucrecia.yanez@scsalud.es
Sponsor
Primary sponsor
- Full Name
- Catapult Therapeutics B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- CAP-100
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