Clinical trial • Phase I/II • Immunology|Haematology|Oncology
Human T lymphoid progenitor cells (HTLP) for Hematologic malignancies|Acute myeloid leukemia
Phase I/II trial of Human T lymphoid progenitor cells (HTLP) for Hematologic malignancies|Acute myeloid leukemia. 10 participants.
Overview
- Trial Therapeutic Area
- Immunology|Haematology|Oncology
- Trial Disease
- Hematologic malignancies|Acute myeloid leukemia
- Trial Stage
- Phase I/II
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 22-07-2024
- First CTIS Authorization Date
- 20-08-2024
Trial design
Phase I/II trial across 5 sites in France.
- Target Sample Size
- 10
- Trial Duration For Participant
- 2007
Eligibility
Recruits 10 No vulnerable population selected; trial includes adult patients only (isVulnerablePopulationSelected: false); no details provided on assent or special consent procedures..
- Vulnerable Population
- No vulnerable population selected; trial includes adult patients only (isVulnerablePopulationSelected: false); no details provided on assent or special consent procedures.
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 66
- Consent Approach
- No detailed consent approach provided. Trial includes adult patients; informed consent is implied to be provided by participants themselves. isVulnerablePopulationSelected: false. No information on assent or languages.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 10
France
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 11-07-2025
- Processing Time Days
- 359
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 75
- Principal Investigator Name
- OLIVIER HERMINE
- Principal Investigator Email
- olivier.hermine@aphp.fr
- Contact Person Name
- OLIVIER HERMINE
- Contact Person Email
- olivier.hermine@aphp.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- 94
- Principal Investigator Name
- Jean-Henri BOURHIS
- Principal Investigator Email
- jean-henri.bourhis@gustaveroussy.fr
- Contact Person Name
- Jean-Henri BOURHIS
- Contact Person Email
- jean-henri.bourhis@gustaveroussy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 75
- Principal Investigator Name
- NICOLAS BOISSEL
- Principal Investigator Email
- nicolas.boissel@aphp.fr
- Contact Person Name
- NICOLAS BOISSEL
- Contact Person Email
- nicolas.boissel@aphp.fr
- Site Name
- CHU De Bordeaux
- Department Name
- 33
- Principal Investigator Name
- Edouard FORCADE
- Principal Investigator Email
- edouard.forcade@chu-bordeaux.fr
- Contact Person Name
- Edouard FORCADE
- Contact Person Email
- edouard.forcade@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- 31
- Principal Investigator Name
- Anne HUYNH
- Principal Investigator Email
- huynh.anne@iuct-oncopole.fr
- Contact Person Name
- Anne HUYNH
- Contact Person Email
- huynh.anne@iuct-oncopole.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Human T Lymphoid Progenitor (HTLP) injection
- Active Substance
- Human T lymphoid progenitor cells (HTLP)
- Modality
- Cell therapy
- Routes Of Administration
- Injection
- Route
- Injection
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