Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients
ConditionDiffuse Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMiltenyi Biomedicine GmbH
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- MB-CART2019.1
- Standard of Care
Treatment groups
213 Participants
are divided into 3 treatment groupsSponsors and collaborators
Miltenyi Biomedicine GmbH
Lead sponsor
ICON plc
Collaborator
Source ClinicalTrials.gov