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Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma - Trial NCT03704298

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.

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NCT03704298
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT03704298
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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

Study Focus

Cyclophosphamide

Interventional

drug

Sponsor & Location

Kite, A Gilead Company

Gilead Sciences

Palo Alto,Santa Monica,Tampa,Boston,New York, United States of America

Timeline & Enrollment

Phase 1

Nov 20, 2018

Jun 01, 2022

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 lymphoma
B-cell lymphoma, unspecified
Small cell B-cell lymphoma
Mediastinal (thymic) large B-cell lymphoma
Chronic lymphocytic leukaemia of B-cell type

Data Source

ClinicalTrials.gov

NCT03704298

Non-Device Trial