Clinical trial • Phase II • Oncology|Neurology

Lisocabtagene maraleucel for Primary central nervous system lymphoma

Phase II trial of Lisocabtagene maraleucel for Primary central nervous system lymphoma. None/Not specified-controlled. 24 participants.

Overview

Trial Therapeutic Area
Oncology|Neurology
Trial Disease
Primary central nervous system lymphoma
Trial Stage
Phase II
Drug Modality
Cell therapy|Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
27-06-2025
First CTIS Authorization Date
29-10-2025

Trial design

None/Not specified-controlled Phase II trial across 26 sites in France, Germany.

Comparator
None/Not specified
Target Sample Size
24

Eligibility

Recruits 24 No vulnerable population selected. Participants are adults (18 years or older); informed consent is obtained from participants. No assent or minor-consent procedures are described..

Vulnerable Population
No vulnerable population selected. Participants are adults (18 years or older); informed consent is obtained from participants. No assent or minor-consent procedures are described.

Inclusion criteria

  • {"criterion_text":"- Participants (18 years or older) with a new diagnosis of PCNSL confirmed by laboratory tests will take part in the study.\n- To be enrolled in the study, participants cannot be eligible for ASCT, must be a good fit for receiving a treatment plan that includes HD-MTX.\n- Participants must have previously been treated only with standard treatments, and before agreeing to join the study, the signs of their cancer must be either completely gone or mostly gone.\n- They must have an ECOG performance score of 0 to 2, which means they are able to carry out their daily activities but may not be able to work."}

Exclusion criteria

  • {"criterion_text":"- Participants can't have a type of brain cancer that spread from another part of the body, or any serious medical condition or laboratory test result that would make it too risky for them to join the study, based on the doctor's judgment.\n- Participants may not have had another type of cancer that has not been in remission (no signs of cancer) for at least 2 years.\n- Other exclusion reasons may include previous treatments, having certain infections that are not under control or an active autoimmune disease that requires treatment to suppress the immune system."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The proportion of participants in whom the cancer gets worse, or who passed away, within 12 months after getting liso-cel.","definition_or_measurement_approach":"Measured as the proportion of participants with disease progression or death within 12 months after liso-cel administration."}

Secondary endpoints

  • {"endpoint_text":"- The time it takes for the cancer to worsen","definition_or_measurement_approach":"Measured as time from enrollment to disease progression."}
  • {"endpoint_text":"- The time it takes for the participant to start a new cancer treatment","definition_or_measurement_approach":"Measured as time from enrollment to initiation of subsequent anticancer therapy."}
  • {"endpoint_text":"- The time it takes for the participants to pass away, after they enroll into the study;","definition_or_measurement_approach":"Measured as overall survival time from enrollment to death."}
  • {"endpoint_text":"- The proportion of participants with no detectable signs of cancer","definition_or_measurement_approach":"Measured as proportion of participants achieving no detectable disease at assessments during the study."}
  • {"endpoint_text":"- The proportion of participants with improvement in signs (complete and partial responses), at any time after getting the liso-cel treatment and before the cancer gets worse, they start a new cancer treatment, or the study ends","definition_or_measurement_approach":"Measured as objective response rate (complete + partial responses) prior to progression, subsequent therapy, or study end."}
  • {"endpoint_text":"- How long the responses last","definition_or_measurement_approach":"Measured as duration of response from first documented response until progression or censoring."}
  • {"endpoint_text":"- How the treatment affects the participants' quality of life","definition_or_measurement_approach":"Measured using patient-reported quality of life assessments (documents reference EORTC QLQ instruments)."}
  • {"endpoint_text":"- What kinds of health problems participants experience during the study, how severe they are, and how often they happen","definition_or_measurement_approach":"Measured as type, severity and frequency of adverse events collected during the study."}

Recruitment

Planned Sample Size
24
Recruitment Window Months
35
Consent Approach
Informed consent is obtained from participants (adults). Subject information and informed consent forms are available in French and German (document listings include L1_FR_SIS-ICF and L1_DE_SIS-ICF files). No assent or minor-consent procedures are described; participants must be 18 years or older.

Geography

Total Number Of Sites
26
Total Number Of Participants
31

France

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
42
Number Of Sites
16
Number Of Participants
19

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Clinical Haematology
Contact Person Name
Lucie OBERIC
Contact Person Email
oberic.lucie@iuct-oncopole.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Clinical Haematology
Contact Person Name
Luc FORNECKER
Contact Person Email
lm.fornecker@icans.eu
Site Name
Institut Curie
Department Name
Clinical Haematology
Contact Person Name
Adrien GILBERT
Contact Person Email
adrien.gilbert@curie.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Clinical Haematology
Contact Person Name
Charles HERBAUX
Contact Person Email
c-herbaux@chu-montpellier.fr
Site Name
Hospices Civils De Lyon
Department Name
Clinical Haematology
Contact Person Name
Hervé GHESQUIERES
Contact Person Email
herve.ghesquieres@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Clinical Haematology
Contact Person Name
Frank MORSCHHAUSER
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Clinical Haematology
Contact Person Name
Roch HOUOT
Contact Person Email
roch.houot@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinical Haematology
Contact Person Name
Benoit TESSOULIN
Contact Person Email
benoit.tessoulin@chu-nantes.fr
Site Name
CHRU De Nancy
Department Name
Clinical Haematology
Contact Person Name
Arnaud CAMPIDELLI
Contact Person Email
a.campidelli@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Clinical Haematology
Contact Person Name
Michael LOSCHI
Contact Person Email
loschi.m@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Clinical Haematology
Contact Person Name
François-Xavier GROS
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Clinical Haematology
Contact Person Name
Sylvain CHOQUET
Contact Person Email
sylvain.choquet@aphp.fr
Site Name
Centre Henri Becquerel
Department Name
Clinical Haematology
Contact Person Name
Vincent CAMUS
Contact Person Email
vincent.camus@chb.unicancer.fr
Site Name
Institut Paoli Calmettes
Department Name
Clinical Haematology
Contact Person Name
Gabriel BRISOU
Contact Person Email
brisoug@ipc.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Clinical Haematology
Contact Person Name
Steeve CHEVREUX
Contact Person Email
steeve.chevreux@chu-dijon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Clinical Haematology
Contact Person Name
Catherine THIEBLEMONT
Contact Person Email
catherine.thieblemont@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
147
Number Of Sites
10
Number Of Participants
12

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Benjamin Franklin, Dept. of Hematology, Oncology & Tumor Immunology
Contact Person Name
Björn CHAPUY
Contact Person Email
bjoern.chapuy@charite.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Dept. Medicine V, Stem Cell Transplant Unit
Contact Person Name
Peter DREGER
Site Name
Universitaetsklinikum Essen AöR
Department Name
Department of Hematology and Stem Cell Transplantation
Contact Person Name
Bastian von Tresckow
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department of Stem Cell Transplantation, Center of Oncology
Contact Person Name
Francis AYUK
Contact Person Email
ayuketang@uke.de
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Department I of Internal Medicine
Contact Person Name
Jan-Michel HEGER
Contact Person Email
jan-michel.heger@uk-koeln.de
Site Name
Medical Center - University Of Freiburg
Department Name
Department of Internal Medicine I, Hematology, Oncology and Stem-Cell Transplantation
Contact Person Name
Elisabeth SCHORB
Site Name
Universitaetsmedizin Goettingen
Department Name
Clinic for Hematology and Medical Oncology
Contact Person Name
Justin HASENKAMP
Site Name
Klinikum Chemnitz gGmbH
Department Name
Internal Medicine III
Contact Person Name
Mathias HÄNEL
Contact Person Email
m.haenel@skc.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Department of Internal Medicine Ill
Contact Person Name
Andreas VIARDOT
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Clinic for Haematology, Oncology, Stem Cell Transplantation and Palliative Medicine
Contact Person Name
Gerald ILLERHAUS

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Pharmaceutical Product Development LLC
Responsibilities
PK Analysis, Bone Marrow Aspirate, Whole Blood SPM Vector Sequencing
Name
Clincierge
Responsibilities
Patient reimbursement
Name
LYSARC
Responsibilities
Monitoring
Name
Labcorp Central Laboratory Services LP
Responsibilities
Sample processing

Third parties

  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Histopathology","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Licensing and translation services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"PK Analysis, Bone Marrow Aspirate, Whole Blood SPM Vector Sequencing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sample processing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Clincierge","duties_or_roles":"Patient reimbursement","organisation_type":"Industry"}
  • {"country":"France","full_name":"LYSARC","duties_or_roles":"Monitoring","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Foresight Diagnostics, Inc","duties_or_roles":"ctDNA Testing","organisation_type":"Industry"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage for HA Safety Requirement","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Lisocabtagene maraleucel
Active Substance
Lisocabtagene maraleucel
Modality
Cell therapy
Routes Of Administration
Intravenous
Route
Intravenous

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