First Dose of Off-the-Shelf CAR T Given to Patients with R/R T-ALL/LBL

A patient with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL) has received the first dose of WU-CART-007, an off-the-shelf CD7-targeting CAR T-cell therapy.

Currently, the only U.S. Food & Drug Administration (FDA)-approved therapy for relapsed/refractory T-ALL is nelarabine. WU-CART-007 is an off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy “designed to overcome the technological challenges of harnessing CAR-T cells to treat CD7-positive hematological malignancies.”

The manufacturer, Wugen, is using CRISPR/Cas9 gene editing technology to delete CD7 and the T-cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating risk of graft-versus-host disease. The product is manufactured using healthy donors to “eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting.”

WU-CART-007 is currently being tested in a phase 1/2 trial. The trial will test the safety and tolerability of a single dose of the off-the-shelf product after receipt of lymphodepleting conditioning therapy, and to define the recommended phase 2 dose, cellular kinetics, and pharmacodynamics.

The FDA has also announced Orphan Drug Designation for WU-CART-007 for the treatment of acute lymphoblastic leukemia.

Source: Wugen Press Release, March 2022