QH10304-BAL-01

QH10304-BAL-01 is an allogeneic CD19-targeted CAR-γδT cell therapy being investigated for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)[1][2][3]. This therapy belongs to the CAR-T cell modality, specifically using γδT cells engineered to target CD19, a marker commonly expressed on B-cell malignancies[1][2]. The therapy is currently being evaluated in clinical trials to assess its safety, optimal dosage, and effectiveness in treating CD19-positive relapsed/refractory B-ALL[2][3]. The trial design includes a primary objective to determine the safety profile and establish a recommended Phase 2 dose (RP2D), with secondary objectives focused on evaluating efficacy[2]. The clinical trial (identified as NCT06696833) involves patients aged 14 years and older with confirmed B-ALL diagnosis according to WHO classification, who have relapsed or refractory disease with CD19-positive leukemia cells[2]. The treatment protocol includes a conditioning regimen with cyclophosphamide and fludarabine prior to the cell infusion[2]. **Technical Details** The therapy utilizes allogeneic (donor-derived) γδT cells that have been genetically modified to express a chimeric antigen receptor (CAR) targeting CD19[1][2]. This approach combines the natural anti-tumor properties of γδT cells with the specific targeting capability of CAR technology directed against CD19-expressing malignant cells. The development of this therapy represents part of the growing field of "off-the-shelf" cell therapies that aim to overcome some limitations of autologous (patient-derived) CAR-T approaches, potentially offering a more readily available treatment option for patients with aggressive hematologic malignancies.

Other names

Allogeneic CD19-targeted CAR-γδT cellsCD19-targeted CAR-γδT cells