At a glance
ClinicalIndex Comparison Record- ✓Histologically proven DLBCL and associated subtypes per WHO 2016 classification
- ✓Relapsed or refractory disease after first-line chemoimmunotherapy
- ✓Received adequate first-line therapy with anthracycline-based regimen and rituximab
- ✓Archival or fresh tumor tissue available for central pathology review
- ✕Prior CAR-T or other genetically modified T-cell therapy
- ✕More than one line of prior treatment for DLBCL
- ✕Prior HSCT <3 months at leukapheresis
- ✕ECOG performance status >2 (Part I) or ECOG >1 (Part II)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04844866Phase 2RecruitingUpdate OverdueCompletion was 17mo agoA Pivotal Phase II Randomised, Multi-centre, Open-label Study to Evaluate the Efficacy and Safety of MB-CART2019.1 Compared to SoC Therapy in Participants With r/r DLBCL, Who Are Not Eligible for HDC and ASCT
In Brief
A Phase 2 clinical trial evaluating MB-CART2019.1 and Standard of Care for Diffuse Large B-cell Lymphoma. Currently recruiting, targeting 213 participants across 51 sites in 14 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Single infusion of 2.5 × 10\^6 CAR-transduced autologous T cells per kg/body weight.
Single infusion of 2.5 × 10\^6 CAR-transduced autologous T cells per kg/body weight.
R-GemOx R-Pola
Interventions
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.
Standard of Care