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JOURNAL ONKOLOGIE – STUDIE
DALY 2-EU

Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients

Rekrutierend

NCT-Nummer:
NCT04844866

Studienbeginn:
August 2021

Letztes Update:
01.02.2024

Wirkstoff:
R-GemOx or BR plus polatuzumab vedotin

Indikation (Clinical Trials):
Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Miltenyi Biomedicine GmbH

Collaborator:
ICON plc

Studienleiter

Peter Borchmann, Prof. Dr.
Principal Investigator
University Hospital Cologne

Kontakt

Gregor Zadoyan, Dr.
Kontakt:
Phone: +49 2204 8306
Phone (ext.): 6639
E-Mail: gregor.zadoyan@miltenyi.com» Kontaktdaten anzeigen
Silke Holtkamp, Dr.
Kontakt:
Phone: +49 2204 8306
Phone (ext.): 6639
E-Mail: silke.holtkamp@miltenyi.com» Kontaktdaten anzeigen

Studienlocations
(3 von 54)

Universitatsklinikum Augsburg
86156 Augsburg
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christoph Schmid, Dr.
Phone: +49 821 4003714
E-Mail: christoph.schmid@klinikum-augsburg.de» Ansprechpartner anzeigen
Helios Klinikum Berlin - Buch
13125 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsklinikum Knappschaftskrankenhaus Bochum der Ruhr-Universitat Bochum
44892 Bochum
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsklinikum Koeln
50937 Cologne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Peter Borchmann, Prof.
Phone: +49 221 478 88159
E-Mail: peter.borchmann@uk-koeln.de» Ansprechpartner anzeigen
Klinikum Erlangen der Friedrich-Alexander-Universitaet Erlangen-Nuernberg
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Andreas Mackensen, Prof. Dr.
Phone: +49 9131 85-35954
E-Mail: andreas.mackensen@uk-erlangen.de» Ansprechpartner anzeigen
Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Bastian Von Tresckow, Dr.
Phone: +49 2017233136
E-Mail: bastian.vontresckow@uk-essen.de» Ansprechpartner anzeigen
Universitaetsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Peter Dreger, Prof. Dr.
Phone: +49 6221568008
E-Mail: peter.dreger@med.uni-heidelberg.de» Ansprechpartner anzeigen
Gynäkologisches Tumorzentrum am Universitätsklinikum Leipzig
4103 Leipzig
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Vladan Vucinic, Dr. med.
Phone: +49 341 97 13050
E-Mail: Vladan.Vucinic@medizin.uni-leipzig.de» Ansprechpartner anzeigen
Klinikum der Universitat München, Studienzentrale fur Hematologie der Medizinischen Klinik II
81377 München
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Veit Bücklein, Dr.
Phone: +49 8944000
E-Mail: veit.buecklein@med.uni-muenchen.de» Ansprechpartner anzeigen
Universitaetsklinikum Muenster
48149 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Matthias Stelljes, Prof. Dr.
Phone: +49 258352801
E-Mail: matthias.stelljes@ukmuenster.de» Ansprechpartner anzeigen
University Hospital of Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Wolfgang Bethge, Prof. Dr.
Phone: +49 70712983176
E-Mail: wolfgang.bethge@med.uni-tuebingen.de» Ansprechpartner anzeigen
Universitatsklinikum Innsbruck Universitatsklinik fur Innere Medizin V
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Jakob Rudzki, Dr.
Phone: +43-512-504-82157
E-Mail: jakob.rudzki@tirol-kliniken.at» Ansprechpartner anzeigen
Ordensklinikum Linz GmbH Elisabethinen
4020 Linz
AustriaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Veronika Buxhofer-Ausch, Dr.
Phone: +4373276764409
E-Mail: veronika.buxhofer@elisabethinen.or.at» Ansprechpartner anzeigen
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH)
1090 Wien
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Ulrich Jaeger, Prof.
Phone: +4314040044090
E-Mail: ulrich.jaeger@meduniwien.ac.at» Ansprechpartner anzeigen
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
3000 Leuven
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Peter Vandenberghe, Prof.
Phone: +32 16346889
E-Mail: peter.vandenberghe@uzleuven.be» Ansprechpartner anzeigen
Universite Catholique de Louvain Namur, Centre Hospitalier Universitaire Dinant Godinne Site Godinne
5530 Yvoir
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Marc André, Prof.
Phone: +32 81423831
E-Mail: marc.andre@chuuclnamur.uclouvain.be» Ansprechpartner anzeigen
Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor
94010 Créteil
FranceRekrutierend» Google-Maps
Ansprechpartner:
Francois Lemmonier, Dr.
Phone: +33 1 49 81 21 71
E-Mail: Francois.LeMonnier@aphp.fr» Ansprechpartner anzeigen
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon Groupement Hospitalier Sud
69495 Lyon
FranceRekrutierend» Google-Maps
Ansprechpartner:
Emmanuel Bachy, Dr.
Phone: +33 4 78 86 22 05
E-Mail: emmanuel.bachy@chu-lyon.fr» Ansprechpartner anzeigen
Centre Hospitalier Universitaire de Montpellier - Hopital Saint-Eloi
34090 Montpellier
FranceRekrutierend» Google-Maps
Ansprechpartner:
Guillaume Cartron, Prof.
Phone: +33 4 67 33 83 62
E-Mail: g-cartron@chu-montpellier.fr» Ansprechpartner anzeigen
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
44093 Nantes
FranceRekrutierend» Google-Maps
Ansprechpartner:
Thomas Gastinne, Dr.
Phone: +33 2 40 08 32 71
E-Mail: thomas.gastinne@chu-nantes.fr» Ansprechpartner anzeigen
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
33600 Pessac
FranceRekrutierend» Google-Maps
Ansprechpartner:
Francois-Xavier Gros, Dr.
Phone: +33 5 57 65 64 94
E-Mail: francois-xavier.gros@chu-bordeaux.fr» Ansprechpartner anzeigen
Centre Hospitalier Universitaire de Poitiers
86000 Poitiers
FranceRekrutierend» Google-Maps
Ansprechpartner:
Stephanie Guidez, Dr.
Phone: +33 5 49 44 46 89
E-Mail: stephanie.guidez@chu-poitiers.fr» Ansprechpartner anzeigen
Institut Universitaire du Cancer Service d´hématologie
31059 Toulouse
FranceRekrutierend» Google-Maps
Ansprechpartner:
Pierre Bories, Dr.
Phone: +33 531 1565 14
E-Mail: bories@onco-occitanie.fr» Ansprechpartner anzeigen
Del-Pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
1097 Budapest
HungaryAktiv, nicht rekrutierend» Google-Maps
Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
4032 Debrecen
HungaryRekrutierend» Google-Maps
Ansprechpartner:
Arpad Illes, Prof. Dr.
Phone: +36 52255601
E-Mail: illesarpaddr@gmail.com» Ansprechpartner anzeigen
Amsterdam Universitaire Medische Centra (UMC) - locatie Amsterdam Medisch Centrum (AMC)
1105 AZ Amsterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Marie Kersten, Dr.
Phone: +31 20566 5955
E-Mail: m.j.kersten@amsterdamumc.nl» Ansprechpartner anzeigen
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
02-097 Warsaw
PolandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Basak Grzegorz, Prof.
Phone: +48 225991418
E-Mail: grzegorz.basak@wum.edu.pl» Ansprechpartner anzeigen
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
50367 Wrocław
PolandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Tomasz Wrobel, Prof.
Phone: +48 717842576
E-Mail: tomasz_wrobel@wp.pl» Ansprechpartner anzeigen
Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)
08036 Barcelona
SpainRekrutierend» Google-Maps
Ansprechpartner:
Valentin Ortiz, Dr.
Phone: +34 932275400
Phone (ext.): 4366
E-Mail: VORTIZ@clinic.cat» Ansprechpartner anzeigen
Hospital Universitario Fundacion Jimenez Diaz
28040 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Raul Cordoba Mascunano, Dr.
Phone: +34915504800
E-Mail: raul.cordoba@fjd.es» Ansprechpartner anzeigen
Hospital Clinico Universitario de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Ansprechpartner:
Alejandro Martin Garcia-Sancho, Dr.
Phone: +34 923291384
E-Mail: amartingar@usal.es» Ansprechpartner anzeigen
Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Jose Antonio Perez Simon, Prof.
Phone: +34 955013273
E-Mail: josea.perez.simon.sspa@juntadeandalucia.es» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

This study should determine superiority of MB-CART2019.1 treatment compared to SoC therapy

with R-GemOx (rituximab, gemcitabine and oxaliplatin) with respect to event-free survival in

second-line therapy in participants with R-R DLBCL, who are non-eligible for high-dose

chemotherapy and autologous stem cell transplantation.

MB-CART2019.1 is designed to effectively target malignant B cells in patients suffering from

late stage haematological B-cell malignancies. MB-CART2019.1 consists of autologous cluster

of differentiation CD20/CD19 chimeric antigen receptor (CAR) transduced CD4/CD8 enriched T

cells, derived from a leukapheresis and processed by using the CliniMACS Prodigy®. Patients

who are suitable for this study will be randomized 1:1 to either MB-CART2019.1 or SoC. Both

treatment arms are unblinded.

MB-CART2019.1 arm: Single infusion of fresh formulation of 2.5 × 10^6 CAR-transduced

autologous T cells. IMP is only to be administered after a lymphodepleting chemotherapy with

fludarabine and cyclophosphamide. For MB-CART2019.1 production, patients will undergo a

leukapheresis.

SoC arm: R-GemOx (8 cycles of 14 days each) or (10% of SoC arm) BR (Bendamustine/Rituximab) +

polatuzumab vedotin (6 cycles of 21 days each). Participants from the SoC arm are allowed to

be treated with MB-CART2019.1 upon request by the investigator if at least one of the

following criteria is confirmed by the IRC:

- Relapse or progression occurring at any time within 1 year after randomisation.

- Failure to achieve PR or CR at or beyond Week 8 after randomisation (after 4 cycles of

R-GemOx or 3 cycles of BR plus polatuzumab vedotin) and the start of a new anti-lymphoma

therapy is warranted.

The duration of the active part of the study for each individual participant from screening

to the end of the 1-year follow-up after infusion of MB-CART2019.1 cells (experimental arm)

or the start of SoC therapy (comparator arm) will be approximately 55 weeks. The LTFU in Year

2 after infusion of MB-CART2019.1 cells or the start of treatment in the comparator arm will

not be part of the active part of the clinical study and will be reported separately.

Ein-/Ausschlusskriterien

1. Histologically proven DLBCL and associated subtypes, according to the World Health

Organization (WHO) 2016 classification including:

- DLBCL not otherwise specified (NOS).

- High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements

with DLBCL/blastoid/intermediate histology or HGBL with MYC and BCL2 and/or BCL6

rearrangements (double hit lymphoma/triple hit lymphoma).

- High-grade BCL, NOS.

- Primary (thymic) large mediastinal BCL.

- Disease transformed from an earlier diagnosis of low-grade lymphoma (e.g. an

indolent pathology such as follicular lymphoma, marginal zone lymphoma) into

DLBCL with DLBCL disease progression subsequent to DLBCL-directed systemic

treatment.

- Follicular lymphoma Grade 3B.

2. Relapsed or refractory disease after first-line chemoimmunotherapy:

- Refractory disease defined as no CR to first-line therapy (e.g. R-CHOP

[rituximab, cyclophosphamide, daunorubicin, vincristine and prednisone]).

- Progressive disease (PD) after at least 2 full cycles of first-line therapy.

- Stable disease (SD) after 4 cycles of first-line therapy.

- PR as best response after at least 6 cycles of first-line therapy and

biopsy-proven persistent disease (except where prohibited due to

comorbidities) within ≤ 24 months from the start of the first-line therapy.

- Relapsed disease defined as complete remission to first-line therapy followed by

biopsy-proven disease progression (except where prohibited due to comorbidities)

within ≤ 24 months from the start of the first-line therapy.

3. Participants must have received adequate first-line therapy containing at least the

combination of an anthracycline-based regimen and rituximab (anti-CD20 monoclonal

antibody). Local therapies (e.g. radiotherapies) will not be considered as line of

therapy if performed during the same line of treatment.

4. Archival paraffin-embedded tumour tissue acquired ≤ 2 years (preferred: ≤ 2 months)

prior to screening for the central pathology review to confirm DLBCL diagnosis must be

made available for participation in this study. If archival paraffin-embedded tumour

tissue is not available, fresh tumour tissue sample (preferred) or core-needle biopsy

must be made available for the central pathology review.

5. Participants deemed ineligible to receive HDC followed by ASCT based on the treating

physician's assessment and meeting the following criteria:

EITHER

- Age ≥ 18 years and

- Prior ASCT (as first-line consolidation) or

- Haematopoietic cell transplantation-specific comorbidity index (HCT-CI) > 3.

OR

- Age ≥ 65 years and ≥ 1of the criteria below:

- Impaired cardiac function (left ventricular ejection fraction [LVEF] < 50%),

or

- Impaired renal function (estimated glomerular filtration rate [eGFR] < 60

mL/min) calculated according to the modified Modification of Diet in Renal

Disease (MDRD) formula, or

- Impaired pulmonary function (diffusing capacity for carbon monoxide or

forced expiratory volume in 1 second < 80%) or dyspnoea on slight activity,

or

- Eastern Cooperative Oncology Group (ECOG) performance status > 1. OR

- Age ≥ 70 years. Documentation of the reason for ineligibility for ASCT must be

present in the participant's source data.

In addition, all participants must fulfil the following criteria:

6. Age ≥ 18 years.

7. Measurable disease according to Lugano criteria. The lesion must be measurable (nodes

> 1.5 cm in the long axis; extranodal lesions > 1 cm in the long axis) and positive on

a positron emission tomography scan.

8. Estimated life expectancy of > 3 months for other reasons than the primary disease.

9. Women of childbearing potential (WOCBP) must agree to use highly effective

contraceptive measures (Pearl index < 1) or practice true sexual abstinence from any

heterosexual intercourse (True abstinence is only acceptable if it is in line with the

preferred and usual life style of the participant.) or must have a vasectomised

partner as the sole sexual partner (The vasectomised partner must have received

medical assessment of the surgical success.) for at least 1 month before the study

start, during the study and in the 12 months following the last dose of study

treatment. A woman is considered a WOCBP, i.e. fertile, following menarche and until

becoming post-menopausal unless permanently sterile. Highly effective methods of

contraception include hormonal contraceptives associated with inhibition of ovulation

(oral, intravaginal, transdermal, injectable, implantable) and intrauterine devices or

systems (e.g. hormonal and non-hormonal) and bilateral tubal occlusion. Permanent

sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral

oophorectomy. A post-menopausal state is defined as no menses for 12 months without an

alternative medical cause. WOCBP who want to become pregnant after completing

treatment should seek advice about oocyte cryoconservation prior to treatment because

of possible irreversible infertility. WOCBP must refrain from egg donation throughout

the study until 12 months after the last dose of study treatment.

Men with non-pregnant WOCBP partners must agree to use highly effective contraceptive

measures (Pearl index < 1, e.g. spermicide and condom or other highly effective

contraceptive measures (Pearl index < 1) taken by their WOCBP partner) or practice

true sexual abstinence from any heterosexual intercourse (True abstinence is only

acceptable if it is in line with the preferred and usual life style of the

participant.), unless they are surgically sterile (meaning at least 2 consecutive

analyses following vasectomy demonstrate absence of sperms in the ejaculate), during

the study and in the 12 months following the last dose of study treatment. Men should

seek advice about sperm conservation prior to treatment because of possible

irreversible infertility. Men must furthermore refrain from sperm donation throughout

the study until 12 months after the last administration of study treatment.

10. In the opinion of the investigator, the participant must be able to comply with all

study-related procedures, medication use and evaluations.

11. Mental capacity and legal ability to consent to participation in the clinical study.

Criteria for Exclusion:

1. Contraindications for R-GemOx, BR plus polatuzumab vedotin, cyclophosphamide and

fludarabine as judged by the treating physician.

2. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.

3. Participants who have received more than one line of treatment for DLBCL or associated

subtypes.

4. Prior haematopoietic stem cell transplantation (HSCT; as first-line consolidation) < 3

months at the time of leukapheresis.

5. ECOG performance status > 2.

6. Absolute neutrophil count < 1,000/μL (unless secondary to bone marrow involvement by

DLBCL as demonstrated by bone marrow biopsy).

7. Platelet count < 50,000/μL (unless secondary to bone marrow involvement by DLBCL as

demonstrated by bone marrow biopsy).

8. Absolute lymphocyte count < 100/μL.

9. Participants who have central nervous system (CNS) lymphoma involvement in present or

past medical history.

10. Participants with the requirement for urgent therapy due to tumour mass effects.

11. Infection with human immunodeficiency virus.

12. Presence of active or prior hepatitis B or C as indicated by serology (for detailed

criteria see Section 10.2.7.10). Treated infection with hepatitis B or C virus unless

confirmed to be polymerase chain reaction negative.

13. Active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

14. Active, severe systemic fungal, viral or bacterial infection.

15. Known history or evidence of severely immunocompromised state, i.e. corticosteroid

treatment > 10 mg/day for more than 6 months.

16. Has received vaccination with live virus vaccines 6 weeks prior to randomisation.

17. Prior CD19-targeted therapy.

18. Known history or presence of seizure activities or on active anti-seizure medications

within the previous 12 months.

19. History or presence of non-malignant CNS disease that, in the judgement of the

investigator, may impair the ability to evaluate neurotoxicity.

20. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic

neuritis or other immunologic or inflammatory disease.

21. Known history or presence of cerebral vascular accident (CVA) within 12 months prior

to randomisation.

Note: In case of history of CVA > 12 months prior to leukapheresis, then the

participant must not have any unstable or life-threatening neurological deficits.

22. Participants with Richter's transformation or Richter's syndrome.

23. Participants who are concurrently on any other experimental treatments or during the

previous 4 weeks or 5 half-lives.

24. Clinical heart failure with New York Heart Association class ≥ 2 or LVEF < 30% or

severe cardiac arrhythmias or QT prolongation (resting QTcF ≥ 450 msec [male] or ≥ 460

msec [female] at screening) that would (according to the evaluation of the

investigator) face an uncontrollable risk by receiving the medications administered in

the trial.

25. Resting peripheral oxygen saturation < 90% on room air.

26. Liver dysfunction as indicated by total bilirubin > 2.5 × institutional upper limit of

normal (ULN), aspartate aminotransferase and/or alanine aminotransferase > 5 × ULN or

typical symptoms like jaundice.

27. Serum creatinine ≥ 2.0 × ULN or eGFR < 30 mL/min calculated according to the modified

MDRD formula.

28. Pregnant or breast-feeding women.

29. Prior history of malignancies other than DLBCL. Exceptions include participants who

have been free of the disease for ≥ 3 years prior to screening and participants with

adequately treated and removed basal cell carcinoma of the skin, squamous cell

carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the

breast, carcinoma in situ of the bladder or incidental histological finding of

untreated localised (T1a, T1b or T1c) prostate cancer under surveillance.

30. History of severe immediate hypersensitivity to any investigational medicinal product

(IMP), auxiliary medicinal product (AxMP), premedication or rescue medication or its

excipients that is scheduled to be given during study participation.

31. Major surgery less than 30 days before start of treatment.

32. Any medical condition likely to interfere with assessment of safety or efficacy of

study treatment.

Studien-Rationale

Primary outcome:

1. Event-free survival (Time Frame - up to 30 weeks after randomisation):
Event-free survival (EFS), defined as the time between the date of randomisation and the date of objective disease progression, failure to achieve partial response (PR) or complete response (CR) at or beyond Week 8 after randomisation leading to a new anti-lymphoma therapy or death of any cause, whichever occurs first, based on independent review committee (IRC) assessment.



Secondary outcome:

1. Progression-free survival (PFS) (Time Frame - up to 99 weeks after randomisation):
defined as the time between the date of randomisation and the date of objective disease progression or death of any cause, whichever occurs first, based on IRC assessment.

2. Best complete response rate (Time Frame - up to 99 weeks after randomisation):
To evaluate the safety and toxicity of MB-CART2019.1 compared to SoC therapy.

3. Duration of complete response (Time Frame - up to 91 weeks):
To evaluate the safety and toxicity of MB-CART2019.1 compared to SoC therapy.

4. Overall survival (Time Frame - up to 99 weeks after randomisation):
To evaluate the safety and toxicity of MB-CART2019.1 compared to SoC therapy.

Studien-Arme

  • Experimental: CAR T-cell MB-CART2019.1
    Single infusion of 2.5 × 10^6 CAR-transduced autologous T cells per kg/body weight.
  • Active Comparator: Standard of Care
    Immunochemotherapy will be administered from the following 2 predefined regimens: R-GemOx (8 cycles of 14 days each) or BR plus polatuzumab vedotin (6 cycles of 21 days each). BR plus polatuzumab vedotin will be capped at a maximum of 10% of participants; i.e. a maximum of 8 participants will be randomised to the BR plus polatuzumab vedotin regimen. Participants from the SoC arm are allowed to be treated with CAR T-cell MB-CART2019.1 upon request by the investigator if at least one of the following criteria is confirmed by the IRC: Relapse or progression occurring at any time within 1 year after randomisation. Failure to achieve PR or CR at or beyond Week 8 after randomisation (after 4 cycles of R-GemOx or 3 cycles of BR plus polatuzumab vedotin) and the start of a new anti-lymphoma therapy is warranted.

Geprüfte Regime

  • MB-CART2019.1:
    MB-CART2019.1 is designed to effectively target malignant B cells in patients suffering from late stage haematological B-cell malignancies. MB-CART2019.1 consists of autologous cluster of differentiation CD20/CD19 chimeric antigen receptor (CAR) transduced CD4/CD8 enriched T cells, derived from a leukapheresis and processed by using the CliniMACS Prodigy® device.
  • R-GemOx or BR plus polatuzumab vedotin (Rituximab, Gemcitabine, Oxaliplatin, Polatuzumab vedotin, Bendamustine, Rituximab):
    Immunochemotherapy will be administered as per arm description.

Quelle: ClinicalTrials.gov


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