CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
KTE-C19 +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02926833
NCT02926833Phase 2Completed

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)

Kite, A Gilead Company·interventional·Posted Oct 6, 2016·Updated Mar 6, 2024

In Brief

A Phase 2 clinical trial evaluating KTE-C19, Atezolizumab, and 2 other interventions for Refractory Diffuse Large B Cell Lymphoma. Completed, enrolled 37 participants across 5 sites.

Detailed Summary

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 participants with refractory diffuse large B-cell lymphoma (DLBCL). Participants who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968 (NCT05041309).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 6, 2016
Enrollment StartSep 29, 2016
Primary CompletionJan 12, 2023
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 9.7 years ago

Interventions

KTE-C19biological

A single infusion of KTE-C19 CAR-T cells administered intravenously

Atezolizumabbiological

Administered intravenously

Cyclophosphamidedrug

Administered intravenously

Fludarabinedrug

Administered intravenously