Clinical trial • Phase I • Haematology

Autologous CD19-directed CAR T cells for Relapsed or refractory CD19+ B-cell neoplasms | Acute lymphoblastic leukaemia (refractory) | Diffuse large B-cell lymphoma (refractory) | Mantle cell lymphoma (refractory)

Phase I trial of Autologous CD19-directed CAR T cells for Relapsed or refractory CD19+ B-cell neoplasms | Acute lymphoblastic leukaemia (refractory) | Dif…

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Relapsed or refractory CD19+ B-cell neoplasms | Acute lymphoblastic leukaemia (refractory) | Diffuse large B-cell lymphoma (refractory) | Mantle cell lymphoma (refractory)
Trial Stage
Phase I
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
15-01-2025
First CTIS Authorization Date
30-01-2025

Trial design

Phase I trial across 2 sites in Poland.

Target Sample Size
6

Eligibility

Recruits 6 No vulnerable populations selected; consent and assent procedures not specified in available data..

Vulnerable Population
No vulnerable populations selected; consent and assent procedures not specified in available data.

Recruitment

Planned Sample Size
6
Recruitment Window Months
30
Consent Approach
Not specified in available data.

Geography

Total Number Of Sites
2
Total Number Of Participants
6

Poland

Earliest CTIS Part Ii Submission Date
24-01-2025
Latest Decision Or Authorization Date
30-01-2025
Processing Time Days
6
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologi
Principal Investigator Name
Jan Zaucha
Principal Investigator Email
jan.zaucha@gumed.edu.pl
Contact Person Name
Jan Zaucha
Contact Person Email
jan.zaucha@gumed.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
KLINIKA HEMATOLOGII, TRANSPLANTOLOGII I CHORÓB WEWNĘTRZNYCH
Principal Investigator Name
Grzegorz Basak
Principal Investigator Email
grzegorz.basak@wum.edu.pl
Contact Person Name
Grzegorz Basak
Contact Person Email
grzegorz.basak@wum.edu.pl

Sponsor

Primary sponsor

Full Name
Famicordtx S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Poland

Third parties

  • {"country":"Poland","full_name":"Polski Bank Komorek Macierzystych Sp. z o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Polski Bank Komorek Macierzystych Sp. z o.o.

Investigational products

Investigational Product Name
Tarcidomgen Kimleucel (autologous CAR T cells)
Active Substance
Autologous CD19-directed CAR T cells
Modality
Cell therapy

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