MB-CART2019.1

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

Advanced therapy medicinal product (ATMP)
Miltenyi Biomedicine
Miltenyi Biomedicine

Development and Regulatory status

None
Phase II Clinical Trials
None
Oct 19 · Granted 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

Jul 20 · PI/II study is active but no longer recruiting [2].
Feb 19 · PI/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].