Clinical trial • Phase I • Haematology

CART19 cells for Relapsed/refractory acute lymphoblastic leukaemia | Relapsed/refractory non-Hodgkin lymphoma

Phase I trial of CART19 cells for Relapsed/refractory acute lymphoblastic leukaemia | Relapsed/refractory non-Hodgkin lymphoma. 18 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Relapsed/refractory acute lymphoblastic leukaemia | Relapsed/refractory non-Hodgkin lymphoma
Trial Stage
Phase I
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
20-06-2024
First CTIS Authorization Date
23-07-2024

Trial design

Phase I trial in Czechia.

Target Sample Size
18

Recruitment

Planned Sample Size
18
Recruitment Window Months
54

Geography

Total Number Of Sites
1
Total Number Of Participants
18

Czechia

Earliest CTIS Part Ii Submission Date
23-01-2024
Latest Decision Or Authorization Date
23-07-2024
Processing Time Days
182
Number Of Sites
1
Number Of Participants
18

Sites

Site Name
Institute Of Hematology And Blood Transfusion
Department Name
Ústav hematologie a krevní transfuze, Klinický úsek
Principal Investigator Name
Jan Vydra
Principal Investigator Email
Jan.Vydra@uhkt.cz
Contact Person Name
Jan Vydra
Contact Person Email
Jan.Vydra@uhkt.cz

Sponsor

Primary sponsor

Full Name
Institute Of Hematology And Blood Transfusion
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Czechia

Investigational products

Investigational Product Name
CART19 cells
Active Substance
CART19 cells
Modality
Cell therapy

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