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NCT03704298

Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma

A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Subjects With Relapsed/Refractory Large B-Cell Lymphoma
Kite, A Gilead Company·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Relapsed/Refractory Large B-cell Lymphoma
Drug/Device/Intervention
Cyclophosphamide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Kite, A Gilead Company
Funder
Gilead Sciences
Location
Palo Alto,Santa Monica,Tampa,Boston,New York, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Nov 20, 2018
End date
Jun 01, 2022
Enrollment
15 participants
Primary outcome

For Phase 1: Percentage of Participants Experiencing Adverse Events defined as Dose Limiting Toxicities (DLTs),For Phase 2: Complete Response Rate

Summary

The primary objectives of this study are:
 
 Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and
 to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2
 
 Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utomilumab in participants
 with refractory large B-cell lymphoma

ICD-10 classifications
Diffuse large B-cell lymphomaB-cell lymphoma, unspecifiedSmall cell B-cell lymphomaMediastinal (thymic) large B-cell lymphomaChronic lymphocytic leukaemia of B-cell type
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03704298
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03704298 through Pure Global AI's free database. This Phase 1 trial is sponsored by Kite, A Gilead Company and is currently Not yet recruiting. The study focuses on Relapsed/Refractory Large B-cell Lymphoma. Target enrollment is 15 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.