CD19/CD22 bispecific CAR-T cells for MRD-positive adult B cell acute lymphoblastic leukemia: a phase I clinical study
Jiahua Niu, Huiying Qiu, Xiang Fang, Lin Zhu, Jun J. Yang, Chongmei Huang, Kun Zhou, Tong Yin, Yu Cai, Baoxia Dong, Yuan Lu, Xuedong Sun, Liping Wan, Xueying Ding, Haopeng Wang, Xianmin Song
Abstract
Measurable residual disease (MRD) is now considered as one of the most important prognostic factors for B cell acute lymphoblastic leukemia (B-ALL), even for patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) [ 1 , 2 ]. Early achievement of MRD negative is imperative, as many studies consistently demonstrated that the patients with a negative MRD during the early time of treatment, especially after induction, had a superior survival [ 3 ]. Chimeric antigen receptor T (CAR-T) cells targeting CD19 or CD22 has been demonstrated as the most effective salvage therapy for refractory/relapsed B-ALL [ 4 , 5 ]. Considering the facts that a lower disease burden was associated with a higher safety profile and dual targeting of CD19/CD22 might lower relapse risk, we designed a phase I study to evaluate the safety and efficacy of CD19/CD22 bispecific targeted CAR-T cells for MRD-positive adult B-ALL patients, especially for primary patients with MRD persistence after early consolidation therapy.