dm+d

Unassigned

New Medicines

CD20 and CD19-positive, relapsed or resistant diffuse large B-cell lymphoma (DLBCL) after first-line therapy in patients who are ineligible for autologous stem cell transplantation

Information

New molecular entity
Miltenyi Biomedicine
Miltenyi Biomedicine

Development and Regulatory status

None
Phase II Clinical Trials
None
Yes
Aug 20Granted orphan drug status in EU (EU/3/20/2327 ) [5].
Oct 19Granted PRIME status in EU [3].

Category

A chimeric antigen receptor T-cell therapy (CAR T). The gene-modified T cells express a chimeric antigen receptor (CAR) directed against CD20 and CD19.
The two most common types of NHL are DLBCL and follicular lymphomas. The overall annual incidence of DLBCL in Europe is 3.8/100,000 but the incidence increases with age and varies considerably across Europe. The annual incidence of follicular lymphomas has increased from 2-3/100,000 during the 1950s to 5-7/100,000 recently [1].
CD20 and CD19-positive, relapsed or resistant diffuse large B-cell lymphoma (DLBCL) after first-line therapy in patients who are ineligible for autologous stem cell transplantation
Intravenous infusion

Trial or other data

Aug 21PII DALY 2-EU trial to evaluate the efficacy and safety of MB-CART2019.1 vs. standard of care therapy in participants with relapsed/refractory DLBCL, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation starts (NCT04844866; M-2020-371). The open-label trial intends to enrol 168 patients in Lithuania. Primary outcome is progression-free survival; collection of these data is due to complete Sep 23 [6].
May 21PII trial to evaluate the safety and efficacy of MB CART2019.1 in patients with relapsed and/or refractory DLBCL starts (NCT04792489; M-2018-344). The open-label trial intends to enrol 65 patients in the US. In preparation for the fresh product infusion, subjects will undergo a lymphodepleting regimen with cyclophosphamide and fludarabine. Cell infusion will be administered intravenously at a dose of 2.5 x 106 CAR+ cells/kg body weight. The study will start with enrollment of 3 subjects in the lead-in safety phase, and after safety is evaluated, the study will continue with enrollment of the remaining subjects. Subjects will be followed for up to 2 years, for efficacy (overall response rate, the primary outcome) and safety outcomes as well as health-related quality of life (HRQol). Collection of primary outcome data is due to complete May 22 [6].
Dec 20PI/II study (NCT03870945) is due to complete collection of primary outcome data [4].
Jul 20PI/II study is active but no longer recruiting [2].
Feb 19PI/II study 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 starts (NCT03870945). 12 adults will be recruited in Germany. Collection of primary outcome data is due to complete Dec 20 [2].