Clinical Trials Search
Clinical Trial 18816
Interventions:Atezolizumab (Tecentriq); Axicabtagene Ciloleucel (KTE-C19); KTE-C19; Not Applicable; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
Study Type: Treatment
Phase of Study: Phase I/II
- Frederick Locke
A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Combination with Atezolizumab in Subjects with Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
The main purpose of this research study is to determine if the investigational products, KTE-C19 and Atezolizumab, when used concurrently and administered after participants receive a 3 day course of chemotherapy, is safe and effective in treating their disease.
The primary objective of phase 1 is to evaluate the safety of KTE-C19 and atezolizumab combination regimens. The primary objective of phase 2 is to evaluate the efficacy of KTE-C19 and atezolizumab, as measured by complete response rate in subjects with refractory diffuse large B-cell lymphoma (DLBCL). Secondary objectives will include assessing the safety and tolerability of KTE-C19 and atezolizumab and additional efficacy, biomarker, pharmacokinetic, and anti-therapeutic antibody endpoints.