Clinical trial • Phase I • Oncology

JNJ-87801493 for Non-Hodgkin lymphoma

Phase I trial of JNJ-87801493 for Non-Hodgkin lymphoma. 70 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-Hodgkin lymphoma
Trial Stage
Phase I
Drug Modality
Other|Bispecific antibody

Key dates

Initial CTIS Submission Date
19-10-2023
First CTIS Authorization Date
19-02-2024

Trial design

Phase I trial across 9 sites in Denmark, Spain, France.

Target Sample Size
70

Eligibility

Recruits 70 Vulnerable population selected; no details on consent or assent provided in the record..

Vulnerable Population
Vulnerable population selected; no details on consent or assent provided in the record.

Recruitment

Planned Sample Size
70
Recruitment Window Months
52
Consent Approach
No information provided on informed consent or assent; consent process not specified in the record.

Geography

Total Number Of Sites
9
Total Number Of Participants
70

Denmark

Earliest CTIS Part Ii Submission Date
15-02-2024
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
670
Number Of Sites
2
Number Of Participants
22

Sites

Site Name
Odense University Hospital
Department Name
Haematological Research unit HFE-X OUH
Principal Investigator Name
Jacob Haaber Christensen
Principal Investigator Email
jacob.h.christensen@rsyd.dk
Contact Person Name
Jacob Haaber Christensen
Contact Person Email
jacob.h.christensen@rsyd.dk
Site Name
Rigshospitalet
Department Name
Department of Haematology, Clinical Research Unit, 2081
Principal Investigator Name
Anna Caroline Riley
Principal Investigator Email
anna.caroline.riley@regionh.dk
Contact Person Name
Anna Caroline Riley
Contact Person Email
anna.caroline.riley@regionh.dk

Spain

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
664
Number Of Sites
4
Number Of Participants
38

Sites

Site Name
Clinica Universidad De Navarra
Department Name
Hematology
Principal Investigator Name
Miguel Angel Canales
Principal Investigator Email
macanales@unav.es
Contact Person Name
Miguel Angel Canales
Contact Person Email
macanales@unav.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Principal Investigator Name
Daniel Morillo
Principal Investigator Email
dmorillo@startmadrid.com
Contact Person Name
Daniel Morillo
Contact Person Email
dmorillo@startmadrid.com
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Norma Gutierrez
Principal Investigator Email
normagu@usal.es
Contact Person Name
Norma Gutierrez
Contact Person Email
normagu@usal.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Pau Abrisqueta
Principal Investigator Email
pabrisqueta@vhio.net
Contact Person Name
Pau Abrisqueta
Contact Person Email
pabrisqueta@vhio.net

France

Earliest CTIS Part Ii Submission Date
06-06-2025
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
168
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hematology and cell therapy
Principal Investigator Name
Emmanuel GYAN
Principal Investigator Email
e.gyan@chu-tours.fr
Contact Person Name
Emmanuel GYAN
Contact Person Email
e.gyan@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinical Hematology
Principal Investigator Name
Benoit TESSOULIN
Principal Investigator Email
benoit.tessoulin@chu-nantes.fr
Contact Person Name
Benoit TESSOULIN
Contact Person Email
benoit.tessoulin@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Services des maladies du sang
Principal Investigator Name
Franck MORSCHHAUSER
Principal Investigator Email
franck.morschhauser@chu-lille.fr
Contact Person Name
Franck MORSCHHAUSER

Sponsor

Primary sponsor

Full Name
Janssen - Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
JNJ-87801493
Modality
Other
Investigational Product Name
CD3 T-Cell Engagers
Modality
Bispecific antibody
Combination Treatment
Yes

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