A Phase 1 Study Evaluating The Safety And Efficacy Of KITE-753, Autologous Anticd19/CD20 CAR T-Cell Therapies, In Patients With Relapsed And/Or Refractory B-Cell Acute Lymphoblastic Leukemia
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to find the recommended dose of KITE-753 in patients with relapsed/refractory B-cell ALL. The safety of KITE-753 will also be studied.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients ≥18 years of age with relapsed and/or refractory B-cell ALL after 1 or more lines of therapy with ≥5% and \<75% bone marrow blasts at the time of consent * Blasts should be positive (≥1%) for either CD19 or CD20 as assessed by flow-cytometry or positive for either CD19 or CD20 by immunohistochemistry * Patients with Philadelphia chromosome-positive ALL are eligible if they are intolerant or have failed 2 lines of any TKI or one line of second-generation TKI * ECOG performance status ≤2 * Adequate organ function: Creatinine clearance \>50 ml/min, direct bilirubin…
Interventions
- DrugKITE-753
Given by infusion
Location
- UT MD AndersonHouston, Texas