Efficacy and Safety of Lisocabtagene Maraleucel (liso-cel) as First-Line Therapy in Adults with Transplant-Ineligible Primary Central Nervous System Lymphoma

Start 23 Dec 2025 · Status Ongoing, recruiting · 2 EU/EEA countries · 26 sites · Protocol CA082-1215

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruiting

Participants planned 55

Countries 2

Sites 26

Primary Central Nervous System Lymphoma

The main objective of this study is to understand if liso-cel works in patients with newly diagnosed Primary Central Nervous System Lymphoma (PCNSL) who are unable to undergo autologus stem cell transplant (ASCT) by evaluating how well this treatment can stop the cancer from getting worse within one year after treatmen…

Key facts

Sponsor: Bristol-Myers Squibb Services Unlimited Company
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04], Diseases [C] - Nervous System Diseases [C10]
Trial duration: 23 Dec 2025 → ongoing
Decision date (initial): 2025-10-29
Transition trial: No
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: No
Funding sources: Bristol-Myers Squibb Services Unlimited Company

External identifiers

EU CT number: 2025-521144-38-00
WHO UTN: U1111-1318-3732
ClinicalTrials.gov: NCT07015242

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Secondary objectives 1

The secondary objectives are designed to understand how well liso-cel works in other ways for patients with PCNSL, how safe it is and what is the impact of this treatment on their quality of life.

Conditions and MedDRA coding

Primary Central Nervous System Lymphoma

Version	Level	Code	Term	System organ class
21.0	LLT	10036685	Primary central nervous system lymphoma	10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

Participants (18 years or older) with a new diagnosis of PCNSL confirmed by laboratory tests will take part in the study.
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.
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.
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 3

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.
Participants may not have had another type of cancer that has not been in remission (no signs of cancer) for at least 2 years.
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 and secondary outcome measures (English text)

Primary endpoints 1

The proportion of participants in whom the cancer gets worse, or who passed away, within 12 months after getting liso-cel.

Secondary endpoints 8

The time it takes for the cancer to worsen
The time it takes for the participant to start a new cancer treatment
The time it takes for the participants to pass away, after they enroll into the study;
The proportion of participants with no detectable signs of cancer
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
How long the responses last
How the treatment affects the participants' quality of life
What kinds of health problems participants experience during the study, how severe they are, and how often they happen

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Lisocabtagene maraleucel

PRD10384909 · Product

Active substance: Lisocabtagene Maraleucel
Pharmaceutical form: CELL SUSPENSION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 100 Other
Max total dose: 100 Other
Max treatment duration: 1 Day(s)
Authorisation status: Not Authorised
MA holder: CELGENE CORPORATION
Paediatric formulation: No
Orphan designation: No

Auxiliary 12

Temozolomide

SUB10889MIG · Substance

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Temozolomide

SUB10889MIG · Substance

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Temozolomide

SUB10889MIG · Substance

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Temozolomide

SUB10889MIG · Substance

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Cyclophosphamide

SUB06859MIG · Substance

Active substance: Cyclophosphamide
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 300 mg/m2 milligram(s)/sq. meter
Max total dose: 900 mg/m2 milligram(s)/sq. meter
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Calcium Folinate

SUB06052MIG · Substance

Active substance: Calcium Folinate
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Calcium Folinate

SUB06052MIG · Substance

Active substance: Calcium Folinate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SOLUTION FOR INJECTION
Max daily dose: 9999 mg/ml milligram(s)/millilitre
Max total dose: 9999 mg/ml milligram(s)/millilitre
Max treatment duration: 9999 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Rituximab

SUB12570MIG · Substance

Active substance: Rituximab
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INJECTION
Max daily dose: 9999 mg/m2 milligram(s)/sq. meter
Max total dose: 9999 mg/m2 milligram(s)/sq. meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 9999 mg/ml milligram(s)/millilitre
Max total dose: 9999 mg/ml milligram(s)/millilitre
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Tocilizumab

SUB20313 · Substance

Active substance: Tocilizumab
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 9999 mg/ml milligram(s)/millilitre
Max total dose: 9999 mg/ml milligram(s)/millilitre
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Procarbazine

SUB10057MIG · Substance

Active substance: Procarbazine
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Fludarabine

SUB07678MIG · Substance

Active substance: Fludarabine
Pharmaceutical form: POWDER FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 30 mg/m2 milligram(s)/square meter
Max total dose: 90 mg/m2 milligram(s)/sq. meter
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaged and over-labelled for clinical trial use

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation: Bristol-Myers Squibb Services Unlimited Company
Address: Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
City: Dublin 15
Postcode: D15 T867
Country: Ireland

Scientific contact point

Organisation: Bristol-Myers Squibb Services Unlimited Company
Contact name: GSM-CT

Public contact point

Organisation: Bristol-Myers Squibb Services Unlimited Company
Contact name: GSM-CT

Third parties 8

Organisation	City, country	Duties
CellCarta ORG-100039881	Antwerp, Belgium	Other
RWS Life Sciences Inc. ORG-100042348	East Hartford, United States	Other
Pharmaceutical Product Development LLC ORG-100016999	Richmond, United States	Other
Labcorp Central Laboratory Services LP ORG-100032236	Indianapolis, United States	Other
Clincierge ORL-000001040	Philadelphia, United States	Other
LYSARC ORG-100010583	Pierre Benite Cedex, France	Other
Foresight Diagnostics, Inc ORL-000012289	Boulder, United States	Other
Azenta Germany GmbH ORG-100022621	Griesheim, Germany	Other

Locations

2 EU/EEA countries · 26 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	19	16
Germany	Ongoing, recruiting	12	10
Rest of world United States	—	24	—

Investigational sites

France

16 sites · Ongoing, recruiting

Centre Hospitalier Universitaire De Lille

Clinical Haematology, Rue Michel Polonovski, 59037, Lille Cedex

Institut Curie

Clinical Haematology, 35 Rue Dailly, 92210, Saint-Cloud

Centre Hospitalier Universitaire De Nantes

Clinical Haematology, 1 Place Alexis Ricordeau, 44000, Nantes

Assistance Publique Hopitaux De Paris

Clinical Haematology, 47 Boulevard De L Hopital, 75651, Paris Cedex 13

Centre Hospitalier Universitaire De Bordeaux

Clinical Haematology, Avenue De Magellan, 33600, Pessac

Centre Hospitalier Universitaire De Toulouse

Clinical Haematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9

Centre Hospitalier Universitaire De Rennes

Clinical Haematology, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9

Institut De Cancerologie Strasbourg Europe

Clinical Haematology, 17 Rue Albert Calmette, 67200, Strasbourg

Centre Henri Becquerel

Clinical Haematology, Rue D Amiens, 76038, Rouen Cedex

Centre Hospitalier Universitaire De Dijon

Clinical Haematology, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon

Assistance Publique Hopitaux De Paris

Clinical Haematology, 1 Avenue Claude Vellefaux, 75010, Paris

Centre Hospitalier Universitaire De Nice

Clinical Haematology, 151 Route De Saint Antoine, 06200, Nice

Hospices Civils De Lyon

Clinical Haematology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite

CHRU De Nancy

Clinical Haematology, Rue Du Morvan, 54500, Vandoeuvre Les Nancy

Institut Paoli Calmettes

Clinical Haematology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille

Centre Hospitalier Universitaire De Montpellier

Clinical Haematology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

Germany

10 sites · Ongoing, recruiting

Universitaetsmedizin Goettingen

Clinic for Hematology and Medical Oncology, Robert-Koch-Strasse 40, Weende, Goettingen

Universitaetsklinikum Ulm AöR

Department of Internal Medicine Ill, Albert-Einstein-Allee 23, Eselsberg, Ulm

Universitaetsklinikum Essen AöR

Department of Hematology and Stem Cell Transplantation, Hufelandstrasse 55, Holsterhausen, Essen

Universitaetsklinikum Koeln AöR

Department I of Internal Medicine, Kerpener Strasse 62, Lindenthal, Cologne

University Medical Center Hamburg-Eppendorf

Department of Stem Cell Transplantation, Center of Oncology, Martinistrasse 52, Eppendorf, Hamburg

Charite Universitaetsmedizin Berlin KöR

Campus Benjamin Franklin, Dept. of Hematology, Oncology & Tumor Immunology, Hindenburgdamm 30, Lichterfelde, Berlin

Klinikum Der Landeshauptstadt Stuttgart gKAöR

Clinic for Haematology, Oncology, Stem Cell Transplantation and Palliative Medicine, Kriegsbergstrasse 60, Mitte, Stuttgart

Universitaetsklinikum Heidelberg AöR

Dept. Medicine V, Stem Cell Transplant Unit, Im Neuenheimer Feld 410, Neuenheim, Heidelberg

Medical Center - University Of Freiburg

Department of Internal Medicine I, Hematology, Oncology and Stem-Cell Transplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau

Klinikum Chemnitz gGmbH

Internal Medicine III, Flemmingstrasse 2, Altendorf, Chemnitz

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
France	2025-12-23		2026-03-10
Germany	2026-01-12		2026-02-18

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol Administrative letter _EN_2025-521144-38-redacted	NA
Protocol (for publication)	D1_Protocol_2025-521144-38-00_redacted	02 EU
Protocol (for publication)	D4_Statement of copyrights_EORTC QLQ-C30_EN	NA
Protocol (for publication)	D4_Statement of copyrights_EORTC-QLQ-BN20_EN	NA
Recruitment arrangements (for publication)	K1_DE_Recruitment Procedure	1.0
Recruitment arrangements (for publication)	K1_FR_Recruitment Procedure_Bilingual	2.0
Subject information and informed consent form (for publication)	L1_DE_SIS-ICF_Exception Release_German_redacted	1.0
Subject information and informed consent form (for publication)	L1_DE_SIS-ICF_Main_German_redacted	1.3
Subject information and informed consent form (for publication)	L1_DE_SIS-ICF_Newborn Sample Collection_German	1.0
Subject information and informed consent form (for publication)	L1_DE_SIS-ICF_Partner Pregnancy_German_redacted	1.0
Subject information and informed consent form (for publication)	L1_FR_SIS-ICF_Clincierge_French	1.0
Subject information and informed consent form (for publication)	L1_FR_SIS-ICF_Exception Release_French_redacted	1.1
Subject information and informed consent form (for publication)	L1_FR_SIS-ICF_Main_French_redacted	1.4
Subject information and informed consent form (for publication)	L1_FR_SIS-ICF_Newborn Sample Collection_French	1.2
Subject information and informed consent form (for publication)	L1_FR_SIS-ICF_Pregnant Partner_French	1.2
Subject information and informed consent form (for publication)	L2_DE_Other Subject Material_Agreement Data Processing Clincierge_German	1.0
Subject information and informed consent form (for publication)	L2_FR_Other Subject Material_Guide Patient and Caregiver_French	1.0
Subject information and informed consent form (for publication)	L2_FR_Other Subject Material_Subject Card_French	1.0
Subject information and informed consent form (for publication)	L2_FR_Other Subject Material_Subject Diary_French	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis_2025-521144-38_French	2
Synopsis of the protocol (for publication)	D1_Protocol synopsis_EN_2025-521144-38	2

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-06-27	France	Acceptable 2025-10-28	2025-10-29
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-11-21	France	Acceptable 2025-10-28	2025-11-21
3	SUBSTANTIAL MODIFICATION	SM-1	2025-11-28		Acceptable	2026-02-03
4	NON SUBSTANTIAL MODIFICATION	NSM-2	2026-03-12	France	Acceptable	2026-03-12
5	NON SUBSTANTIAL MODIFICATION	NSM-3	2026-05-06	France	Acceptable	2026-05-06
6	NON SUBSTANTIAL MODIFICATION	NSM-4	2026-05-06	France	Acceptable	2026-05-06

Efficacy and Safety of Lisocabtagene Maraleucel (liso-cel) as First-Line Therapy in Adults with Transplant-Ineligible Primary Central Nervous System Lymphoma

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 1

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 4

Exclusion criteria 3

Endpoints

Primary endpoints 1

Secondary endpoints 8

Investigational products

Test 1

Auxiliary 12

Sponsors and contacts

Bristol-Myers Squibb Services Unlimited Company

Scientific contact point

Public contact point

Third parties 8

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 21 files

Application history

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