Clinical trial • Phase I/II • Oncology

JNJ-80948543 (and other CD3 TCEs) for Relapsed/Refractory B-cell Non-Hodgkin lymphoma | Non-Hodgkin's lymphoma

Phase I/II trial of JNJ-80948543 (and other CD3 TCEs) for Relapsed/Refractory B-cell Non-Hodgkin lymphoma | Non-Hodgkin's lymphoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed/Refractory B-cell Non-Hodgkin lymphoma | Non-Hodgkin's lymphoma
Trial Stage
Phase I/II
Drug Modality
Bispecific antibody

Key dates

Initial CTIS Submission Date
01-08-2024
First CTIS Authorization Date
31-10-2024

Trial design

None/Not specified-controlled Phase I/II trial in Spain.

Comparator
None/Not specified
Target Sample Size
24

Recruitment

Planned Sample Size
24
Recruitment Window Months
21

Geography

Total Number Of Sites
5
Total Number Of Participants
24

Spain

Earliest CTIS Part Ii Submission Date
02-10-2024
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
415
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Contact Person Name
Andrea Rivero
Contact Person Email
ANRIVERO@clinic.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Contact Person Name
Mariana Bastos Oreiro
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Contact Person Name
Tycho Baumann
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
Pau Abrisqueta Costa
Contact Person Email
pabrisqueta@vhio.net
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Contact Person Name
Anna Sureda Balari

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
JNJ-80948543 (and other CD3 TCEs)
Modality
Bispecific antibody
Combination Treatment
Yes

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