Cellular Biomedicine Group Inc. announced the approval and commencement of patient enrollment in China for its CALL-1 Phase I clinical trial utilizing its optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with relapsed or refractory (r/r) CD19+ B-cell Acute Lymphoblastic Leukemia. The CALL-1 trial has begun enrollment with final data expected to be available at the end of 2017. Depending on the Phase I CALL-1 results, CBMG expects to initiate a larger Phase II clinical trial as soon as practicable. CBMG’s CALL-1 Phase I dose-escalation trial will use the 3+3 design to evaluate the safety, efficacy and persistence of C-CAR011 in CD19+ r/r ALL patients. CALL-1 is a Phase I single-site, single-arm dose-escalating trial consisting of three patient cohorts using escalating C-CAR011 cell dosing levels with three patients in each cohort. Phase I dose expansion will enroll an additional 6-12 patients to confirm the optimal dose. The primary end points are Dose-Limiting Toxicity and Treatment Emergent Adverse Events. Secondary endpoints will measure Overall Response Rate (CR + CRi, complete remission with incomplete hematopoietic recovery), MRD-CR rate at 8 weeks according to the NCCN Guideline Version 2.2016, Acute Lymphoblastic Leukemia, and overall survival at 6 months.