Clinical trial • Phase I • Oncology

ARI0003 cells for Relapsed/refractory B-cell aggressive lymphoma

Phase I trial of ARI0003 cells for Relapsed/refractory B-cell aggressive lymphoma. 52 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed/refractory B-cell aggressive lymphoma
Trial Stage
Phase I
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
19-09-2023
First CTIS Authorization Date
08-01-2024

Trial design

Phase I trial across 9 sites in Spain.

Target Sample Size
52

Eligibility

Recruits 52 Vulnerable population not selected; no special consent or assent handling is mentioned in the record..

Vulnerable Population
Vulnerable population not selected; no special consent or assent handling is mentioned in the record.

Recruitment

Planned Sample Size
52
Recruitment Window Months
36

Geography

Total Number Of Sites
9
Total Number Of Participants
52

Spain

Earliest CTIS Part Ii Submission Date
01-12-2023
Latest Decision Or Authorization Date
07-05-2025
Processing Time Days
524
Number Of Sites
9
Number Of Participants
52

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Hematology
Principal Investigator Name
Adrian Mosquera Orgeira
Principal Investigator Email
adrian.mosquera.orgeira@sergas.es
Contact Person Name
Adrian Mosquera Orgeira
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Principal Investigator Name
Julio Delgado
Principal Investigator Email
jdelgado@clinic.cat
Contact Person Name
Julio Delgado
Contact Person Email
jdelgado@clinic.cat
Site Name
University Hospital Son Espases
Department Name
Hematology
Principal Investigator Name
Leyre Bento de Miguel
Principal Investigator Email
leyre.bento@ssib.es
Contact Person Name
Leyre Bento de Miguel
Contact Person Email
leyre.bento@ssib.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Principal Investigator Name
Javier Lopez Jiménez
Principal Investigator Email
jljimenez@salud.madrid.org
Contact Person Name
Javier Lopez Jiménez
Contact Person Email
jljimenez@salud.madrid.org
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Principal Investigator Name
Anna Torrent
Principal Investigator Email
atorrent@iconcologia.net
Contact Person Name
Anna Torrent
Contact Person Email
atorrent@iconcologia.net
Site Name
Hospital Universitario Central De Asturias
Department Name
Hematologia y hemoterapia
Principal Investigator Name
José M. García Gala
Principal Investigator Email
jgarciaga@gmail.com
Contact Person Name
José M. García Gala
Contact Person Email
jgarciaga@gmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Hematology
Principal Investigator Name
Miguel Blanquer
Principal Investigator Email
miguelblanquer@gmail.com
Contact Person Name
Miguel Blanquer
Contact Person Email
miguelblanquer@gmail.com
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Fermín Sanchez-Guijo
Principal Investigator Email
ferminsg@usal.es
Contact Person Name
Fermín Sanchez-Guijo
Contact Person Email
ferminsg@usal.es
Site Name
ICO L'HOSPITALET HOSPITAL DURAN I REYNALS
Department Name
Hematology
Principal Investigator Name
Alberto Mussetti
Principal Investigator Email
amussetti@iconcologia.net
Contact Person Name
Alberto Mussetti
Contact Person Email
amussetti@iconcologia.net

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
ARI0003 cells
Active Substance
ARI0003 cells
Modality
Cell therapy
Routes Of Administration
Infusion
Route
Infusion
First In Human
Yes

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