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NCT06079164

Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma

A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma
Kite, A Gilead Company·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Relapsed/Refractory Large B-cell Lymphoma
Drug/Device/Intervention
KITE-197
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Kite, A Gilead Company
Funder
Gilead Sciences
Location
Miami,Austin, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Nov 09, 2023
End date
Dec 01, 2027
Enrollment
39 participants
Primary outcome

Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs),Phase 1b: Complete Remission (CR) Rate

Summary

This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical
 study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in
 participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase
 1b of this clinical study is learn about the effectiveness of the recommended dose of
 KITE-197 in participants with r/r LBCL.
 
 The primary objectives of this study are:
 
 Phase 1a: To evaluate the safety of KITE-197 in participants with r/r LBCL and determine the
 target dose level for Phase 1b.
 
 Phase 1b: To evaluate the efficacy of KITE-197 in participants with r/r LBCL as measured by
 the complete remission (CR) rate.

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
NCT06079164
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06079164 through Pure Global AI's free database. This Phase 1 trial is sponsored by Kite, A Gilead Company and is currently Recruiting. The study focuses on Relapsed/Refractory Large B-cell Lymphoma. Target enrollment is 39 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.