NCT02926833

Study of Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Refractory Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	KTE-C19	A single infusion of KTE-C19 CAR-T cells administered intravenously
BIOLOGICAL	Atezolizumab	Administered intravenously
DRUG	Cyclophosphamide	Administered intravenously
DRUG	Fludarabine	Administered intravenously

Timeline

• Start date: 2016-09-29
• Primary completion: 2023-01-12
• Completion: 2023-01-12
• First posted: 2016-10-06
• Last updated: 2024-03-06
• Results posted: 2020-06-26

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study