Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MB-CART2019.1 Dose level 1 · 1 trial · 1 indication
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...
MB-CART2019.1 Dose level 1 is an investigational therapy being studied for the treatment of B-cell Non Hodgkin Lymphoma. It is a monoclonal antibody-based treatment currently in Phase 1 clinical development. The drug is being evaluated in a clinical trial to assess its safety in patients with this type of lymphoma.
MB-CART2019.1 Dose level 1 is being developed by Icon Plc, a company traded under the ticker symbol ICLR. The drug is currently in Phase 1 clinical development for the treatment of B-cell Non Hodgkin Lymphoma, an oncology indication.
MB-CART2019.1 Dose level 1 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of B-cell Non Hodgkin Lymphoma, and the Phase 1 trial has been completed.
MB-CART2019.1 Dose level 1 has been studied in one clinical trial with the identifier NCT03870945. This Phase 1 trial, titled 'Safety of MB-CART2019.1 in Lymphoma Patients (MB-CART2019.1 Lymphoma / DALY 1)', was completed and enrolled 12 participants with B-cell Non Hodgkin Lymphoma in Germany.
MB-CART2019.1 Dose level 1 is a specific dose level of the drug MB-CART2019.1. The clinical trial NCT03870945 evaluates the safety of MB-CART2019.1 in lymphoma patients, and the dose level 1 refers to one of the doses being tested in this Phase 1 study.