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NCT04314843

Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma

A Phase 1/2 Open-label, Multicenter Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects With Relapsed or Refractory Large B-cell Lymphoma (ZUMA-19)
Kite, A Gilead Company·Phase 1/2·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,Tampa,Evanston,Rochester,Buffalo,New York,Charlotte,Portland,Nashville,Houston, United States of America
Timeline & enrollment
Phase
Phase 1/2
Start date
May 26, 2020
End date
Mar 01, 2022
Enrollment
6 participants
Primary outcome

For Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose Limiting Toxicities (DLTs) Related to Sequenced Therapy with Lenzilumab and Axicabtagene,For Phase 2: Percentage of Participants Experiencing Grade 2 or Higher Neurologic Events Within 28 days of Axicabtagene Ciloleucel Administration

Summary

The primary objectives of this study are:
 
 Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene
 ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the
 most appropriate dose of lenzilumab for Phase 2.
 
 Phase 2: To evaluate the incidence of neurologic events with sequenced therapy given at the
 recommended Phase 2 dose (RP2D) of lenzilumab in participants with relapsed or 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
NCT04314843
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04314843 through Pure Global AI's free database. This Phase 1/2 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 6 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.