Actively Recruiting
Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients
Led by Miltenyi Biomedicine GmbH · Updated on 2026-04-29
213
Participants Needed
52
Research Sites
527 weeks
Total Duration
On this page
Sponsors
M
Miltenyi Biomedicine GmbH
Lead Sponsor
I
ICON plc
Collaborating Sponsor
AI-Summary
What this Trial Is About
In the current protocol version, there are two parts. Part I is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. Part II is a Phase II single-arm, open-label, multi-centre study evaluating the efficacy and safety of MB-CART2019.1 in younger, fit participants with R-R DLBCL. Part II will start after completion of enrolment in Part I.
CONDITIONS
Official Title
Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years with histologically confirmed diffuse large B-cell lymphoma or associated subtypes
- Relapsed or refractory disease after first-line chemoimmunotherapy with adequate prior treatment including anthracycline and rituximab
- Measurable disease according to Lugano criteria with positive PET scans
- Archival or fresh tumor tissue available for central pathology review
- Estimated life expectancy of more than 3 months
- Women of childbearing potential and men with partners agree to use highly effective contraception
- Ability to comply with study procedures and provide informed consent
- ECOG performance status 0-1 (Part II) or up to >1 (Part I)
You will not qualify if you...
- Contraindications to study chemotherapy agents or investigational products as judged by physician
- Prior chimeric antigen receptor or genetically modified T-cell therapy
- More than one prior line of treatment for lymphoma
- Prior stem cell transplantation less than 3 months before leukapheresis
- CNS lymphoma involvement currently or in history
- Requirement for urgent therapy due to tumor mass effects
- Active infections including HIV, hepatitis B or C, syphilis, HTLV-1, SARS-CoV-2, or severe systemic infections
- Severely immunocompromised state or recent live virus vaccination
- Prior CD19-targeted therapy
- Seizure history or anti-seizure medication use within 12 months
- Non-malignant CNS diseases impairing neurotoxicity evaluation
- Autoimmune CNS diseases
- Recent cerebral vascular accident within 12 months
- Richter's transformation or syndrome
- Concurrent experimental treatments within 4 weeks
- Pregnancy or breastfeeding
- History of other malignancies except certain treated skin or in situ cancers
- Severe hypersensitivity to study medications
- Major surgery within 30 days before treatment
- Any medical condition interfering with safety or efficacy assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
LKH - Medizinische Universitaet Graz
Graz, Austria, 8036
Active, Not Recruiting
2
Universitatsklinikum Innsbruck Universitatsklinik fur Innere Medizin V
Innsbruck, Austria, 6020
Actively Recruiting
3
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria, 4020
Actively Recruiting
4
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH)
Vienna, Austria, 1090
Actively Recruiting
5
Jules Bordet lnstitute
Anderlecht, Belgium, 1070
Actively Recruiting
6
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
7
University Hospital Center Zagreb
Zagreb, Croatia, 10000
Not Yet Recruiting
8
University Hospital Hradec Kralove
Hradec Králové, Czechia, 50005
Completed
9
FNsP Ostrava
Ostrava, Czechia, 70852
Completed
10
Helsinki University Comprehensive Cancer Center
Helsinki, Finland, 00029
Not Yet Recruiting
11
Oulu University Central Hospital
Oulu, Finland, 90220
Not Yet Recruiting
12
Turku University Hospital
Turku, Finland, 20520
Not Yet Recruiting
13
Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor
Créteil, France, 94010
Actively Recruiting
14
CHRU de Lille - Hopital Claude Huriez
Lille, France, 59000
Active, Not Recruiting
15
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon Groupement Hospitalier Sud
Lyon, France, 69495
Active, Not Recruiting
16
Centre Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
17
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
Nantes, France, 44093
Active, Not Recruiting
18
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
Pessac, France, 33600
Actively Recruiting
19
Centre Hospitalier Universitaire de Poitiers
Poitiers, France, 86000
Actively Recruiting
20
CHU de Rennes - Hopital de Pontchaillou
Rennes, France, 35033
Actively Recruiting
21
Institut Universitaire du Cancer Service d´hématologie
Toulouse, France, 31059
Actively Recruiting
22
CHU de Nancy Hopitaux de Brabois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
23
Universitatsklinikum Augsburg
Augsburg, Germany, 86156
Actively Recruiting
24
Universitaetsklinikum Knappschaftskrankenhaus Bochum der Ruhr-Universitat Bochum
Bochum, Germany, 44892
Actively Recruiting
25
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
26
Klinikum Erlangen der Friedrich-Alexander-Universitaet Erlangen-Nuernberg
Erlangen, Germany, 91054
Actively Recruiting
27
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
28
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
29
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
30
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
31
Klinikum der Universitat München, Studienzentrale fur Hematologie der Medizinischen Klinik II
München, Germany, 81377
Actively Recruiting
32
University Hospital Regensburg
Regensburg, Germany, 93053
Actively Recruiting
33
University Hospital of Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
34
Del-Pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, Hungary, 1097
Actively Recruiting
35
Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
Debrecen, Hungary, 4032
Actively Recruiting
36
Azienda Ospedaliera San Giovanni Battista Di Torino
Torino, Italy, 10126
Actively Recruiting
37
Amsterdam Universitaire Medische Centra (UMC) - locatie Amsterdam Medisch Centrum (AMC)
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
38
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
39
Leiden University Medical Center (LUMC)
Leiden, Netherlands, 2333 ZA
Actively Recruiting
40
Erasmus University Medical Center
Rotterdam, Netherlands, 3015 GC
Actively Recruiting
41
Uniwersytecki Szpital Kliniczny - Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych
Wroclaw, Poland, 50367
Active, Not Recruiting
42
Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E
Porto, Portugal, 4200-072
Not Yet Recruiting
43
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
44
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, Spain, 08036
Actively Recruiting
45
Catalan Institute of Oncology (ICO) Hospitalet
Barcelona, Spain, 08907
Actively Recruiting
46
Hospital Clínico San Carlos (HCSC)
Madrid, Spain, 28040
Actively Recruiting
47
Hospital Universitario Virgen De La Arrixaca (Huva)
Murcia, Spain, 30120
Actively Recruiting
48
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
49
Hospital Clinico Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
50
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye), 06200
Not Yet Recruiting
51
American Hospital
Şişli, Turkey (Türkiye), 34365
Not Yet Recruiting
52
Koc Universitesi Hastanesi (Koc University Hospital)
Zeytinburnu, Turkey (Türkiye), 34010
Not Yet Recruiting
Research Team
M
Mark Hess, Dr.
CONTACT
G
Gregor Zadoyan, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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