Study Of KITE-753 in R/R B-Cell ALL

Primary Objective: Evaluate the safety of KITE-753 and establish recommended phase 2 dose (RP2D) of KITE-753 in patients with relapsed/refractory B-cell ALL Secondary Objectives: A. Evaluate overall response rate (ORR), defined as complete remission (CR) plus CR with incomplete blood count recovery (CRi) B. Assess duration of response (DOR), event-free survival (EFS) and overall survival (OS) C. Evaluate the number of patients achieving measurable residual disease (MRD)-negativity in the bone marrow (BM), as measured by ClonoSEQ NGS testing (sensitivity 10-6) and flow cytometry (sensitivity 10-4) D. Evaluate the rate of persistent NGS MRD negativity at 6 and 12 months Exploratory Objectives: A. CAR-T-cell expansion (Days 7, 10, 14, 21, 28, then monthly up to 3 months then every 3 months up to 24 months post-infusion) B. B-cell aplasia (Day -5, Day 0, Day 28, monthly up to 3 months and then every 3 months up to 24 months post-infusion) C. MRD-negativity by NGS (at 10-6 sensitivity) (peripheral blood \[PB\] / BM: Day 14 (PB), Day 28 (PB and BM), and then every 3 months (PB and BM) up to 24 months post-infusion) D. Cytokine panel to study cytokine profile including IL1, IL2, IL6, IFN-gamma, TNF-alpha from infusion (Days 0, 3, 5, 7, 10, 14, 28) E. Additional correlatives samples may be collected at baseline, Day28 and every 3 months from infusion. These may include samples used for bulk RNA sequencing of the tumor and germline variants, single cell RNA sequencing of CAR T-cells and assessing the methylation signatures of the CAR T-cells. Sample collection for Exploratory objectives A-E will be done as part of standard of care