Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04844866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2021-03-30
Brief Title:
Efficacy and Safety of MB-CART20191 vs SoC in Lymphoma Patients
Sponsor:
Miltenyi Biomedicine GmbH
Organization:
Miltenyi Biomedicine GmbH
Study Overview
Official Title:
A Pivotal Phase II Randomised Multi-centre Open-label Study to Evaluate the Efficacy and Safety of MB-CART20191 Compared to SoC Therapy in Participants With rr DLBCL Who Are Not Eligible for HDC and ASCT
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DALY 2-EU
Brief Summary:
This is a pivotal Phase II randomised multi-centre open-label study to evaluate the efficacy and safety of MB-CART20191 compared to standard of care therapy in participants with relapsedrefractory diffuse large B-cell lymphoma who are not eligible for high-dose chemotherapy and autologous stem cell transplantation
Detailed Description:
This study should determine superiority of MB-CART20191 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-CART20191 is designed to effectively target malignant B cells in patients suffering from late stage haematological B-cell malignancies MB-CART20191 consists of autologous cluster of differentiation CD20CD19 chimeric antigen receptor CAR transduced CD4CD8 enriched T cells derived from a leukapheresis and processed by using the CliniMACS Prodigy Patients who are suitable for this study will be randomized 11 to either MB-CART20191 or SoC Both treatment arms are unblinded
MB-CART20191 arm Single infusion of fresh formulation of 25 106 CAR-transduced autologous T cells IMP is only to be administered after a lymphodepleting chemotherapy with fludarabine and cyclophosphamide For MB-CART20191 production patients will undergo a leukapheresis
SoC arm R-GemOx 8 cycles of 14 days each or 10 of SoC arm BR BendamustineRituximab polatuzumab vedotin 6 cycles of 21 days each Participants from the SoC arm are allowed to be treated with MB-CART20191 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-CART20191 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-CART20191 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
MB-CART20191 is designed to effectively target malignant B cells in patients suffering from late stage haematological B-cell malignancies MB-CART20191 consists of autologous cluster of differentiation CD20CD19 chimeric antigen receptor CAR transduced CD4CD8 enriched T cells derived from a leukapheresis and processed by using the CliniMACS Prodigy Patients who are suitable for this study will be randomized 11 to either MB-CART20191 or SoC Both treatment arms are unblinded
MB-CART20191 arm Single infusion of fresh formulation of 25 106 CAR-transduced autologous T cells IMP is only to be administered after a lymphodepleting chemotherapy with fludarabine and cyclophosphamide For MB-CART20191 production patients will undergo a leukapheresis
SoC arm R-GemOx 8 cycles of 14 days each or 10 of SoC arm BR BendamustineRituximab polatuzumab vedotin 6 cycles of 21 days each Participants from the SoC arm are allowed to be treated with MB-CART20191 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-CART20191 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-CART20191 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None