Clinical trial • Phase I • Haematology
Allogeneic natural killer cells (amplified/activated) for Diffuse large B-cell lymphoma | Relapsed/refractory diffuse large B-cell lymphoma
Phase I trial of Allogeneic natural killer cells (amplified/activated) for Diffuse large B-cell lymphoma | Relapsed/refractory diffuse large B-cell lympho…
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Diffuse large B-cell lymphoma | Relapsed/refractory diffuse large B-cell lymphoma
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 25-07-2024
- First CTIS Authorization Date
- 04-02-2025
Trial design
open-label, none/not specified-controlled Phase I trial across 2 sites in France.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 10
Eligibility
Recruits 10 Vulnerable population selected in CTIS (isVulnerablePopulationSelected=true); no details on consent or assent handling provided in the submitted data..
- Vulnerable Population
- Vulnerable population selected in CTIS (isVulnerablePopulationSelected=true); no details on consent or assent handling provided in the submitted data.
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 30
- Consent Approach
- Not specified in provided documents.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 10
France
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 15-07-2025
- Processing Time Days
- 298
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Hématologie
- Principal Investigator Name
- Pierre Bories
- Principal Investigator Email
- pierre.bories@onco-occitanie.fr
- Contact Person Name
- Pierre Bories
- Contact Person Email
- pierre.bories@onco-occitanie.fr
- Site Name
- CHU de Montpellier
- Department Name
- Clinical Hematology Department
- Principal Investigator Name
- Guillaume Cartron
- Principal Investigator Email
- g-cartron@chu-montpellier.fr
- Contact Person Name
- Guillaume Cartron
- Contact Person Email
- g-cartron@chu-montpellier.fr
Sponsor
Primary sponsor
- Full Name
- Emercell SAS
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- OT-C001
- Active Substance
- Allogeneic natural killer cells (amplified/activated)
- Modality
- Cell therapy
- First In Human
- Yes
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