Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04844866 | Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients | PHASE2 | RECRUITING | 213 | — | — | Aug 18, 2021 | Sep 30, 2031 | Apr 29, 2026 | 52 | Austria, Belgium +12 |
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.
Best objective response rate (BORR), defined as the proportion of participants with at least one CR or PR between the date of MB-CART2019.1 infusion and the date of objective disease progression, the start of new anti-lymphoma therapy or the date of death from any cause, whichever occurs first, based on IRC assessment.
| Arm | Type | Description |
|---|---|---|
| Part I: CAR T-cell MB-CART2019.1 | EXPERIMENTAL | Single infusion of 2.5 × 10\^6 CAR-transduced autologous T cells per kg/body weight. |
| Part II: CAR T-cell MB-CART2019.1 | EXPERIMENTAL | Single infusion of 2.5 × 10\^6 CAR-transduced autologous T cells per kg/body weight. |
| PART I: Standard of Care | ACTIVE_COMPARATOR | R-GemOx R-Pola |
| Name | Type | Description |
|---|---|---|
| MB-CART2019.1 | GENETIC | 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 | DRUG | Standard of Care |
Part I: 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/intermed...