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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03870945 | Safety of MB-CART2019.1 in Lymphoma Patients (MB-CART2019.1 Lymphoma / DALY 1) | PHASE1 | COMPLETED | 12 | — | — | Feb 25, 2019 | May 28, 2024 | May 28, 2025 | 3 | Germany |
Determination of the MTD, defined as the highest dose level at which \<33% of patients experience DLT until day 28 after infusion of MB-CART2019.1 or 2.5x106 MB-CART2019.1 per kg BW, whichever occurs first.
Safety and toxicity assessment per AE reporting classified according to CTCAE Version 5.
| Arm | Type | Description |
|---|---|---|
| Dose level 1 with 1x10^6 MBCART2019.1 per kg BW | EXPERIMENTAL | The IMP will be administered as an intravenous infusion. This is a 6+3 trial arm with 1x10\^6 MBCART2019.1 per kg BW in a single infusion. If none or one of the six patients at dose level 1 experiences a dose limiting toxicity, another six patients will be treated at dose level 2. If two DLTs are observed at dose level 1 another three patients will be treated with the same dose. Dose escalation continues until at least \>2 patients among a cohort of six to nine patients experience dose-limiting toxicities or dose level 2 is completed. The MTD is defined as the dose level below the dose inducing a DLT in more than 2 patients within one dose level. |
| Dose level 2 with 2.5x10^6 MBCART2019.1 per kg BW | EXPERIMENTAL | The IMP will be administered as an intravenous infusion. This is a 6+3 trial arm with 2.5x10\^6 MBCART2019.1 per kg BW in a single infusion and maximum 2 dose levels. If none or one of the six patients at dose level 1 experiences a dose limiting toxicity, another six patients will be treated at dose level 2. If two DLTs are observed at dose level 1 another three patients will be treated with the same dose. If more than two DLTs are observed at dose level 1, trial will continue at dose level 0. Dose escalation continues until at least \>2 patients among a cohort of six to nine patients experience dose-limiting toxicities or dose level 2 is completed. The MTD is defined as the dose level below the dose inducing a DLT in more than 2 patients within one dose level. |
| Name | Type | Description |
|---|---|---|
| MB-CART2019.1 Dose level 1 | BIOLOGICAL | This is a prospective, multi-center, open phase I/II trial to evaluate feasibility, dosage, safety and toxicity as well as efficacy of ex vivo expanded autologous T cells genetically modified to express anti-CD20 and CD19 immunoreceptor (MBCART2019.1) in patients with relapsed or resistant aggressive CD20 and CD19 positive B-NHL/CLL/SLL. |
| MB-CART2019.1 Dose level 2 | BIOLOGICAL | This is a prospective, multi-center, open phase I/II trial to evaluate feasibility, dosage, safety and toxicity as well as efficacy of ex vivo expanded autologous T cells genetically modified to express anti-CD20 and CD19 immunoreceptor (MBCART2019.1) in patients with relapsed or resistant aggressive CD20 and CD19 positive B-NHL. |
Inclusion Criteria: 1. Refractory/relapsed B-NHL (including malignant transformation like Richter's transformation) with no available approved standard therapy. Including, but not restricted to: 1. Diffuse large B cell lymphoma (DLBCL): relapsed/refractory disease after ASCT or ineligible for A...