Clinical Trial

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

Study acronym: DALY 2-EU
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 28 amendments
This ClinicalTrials.gov record has been amended 28 times since 2021-04-12; most recent amendment 2026-06-08.
Status change: Active, Not Recruiting → Recruiting 2026-04-23
Status change: Recruiting → Active, Not Recruiting 2024-07-18
Status change: Not Yet Recruiting → Recruiting 2021-08-25
Trial Details
NCT Number NCT04844866
Lead Sponsor Miltenyi Biomedicine GmbH
Collaborators: ICON plc
Conditions Diffuse Large B-cell Lymphoma
Enrollment 213 participants
Start Date 2021-08-18
Primary Completion 2025-01-15 (estimated)
Study Completion 2031-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-10