Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma

Trial ID or NCT#

NCT02348216

Status

not recruiting iconNOT RECRUITING

Purpose

This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6). The primary objectives of this study are: * Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens * Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel * Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities Subjects 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.

Official Title

A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Exclusion Criteria:
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Investigator(s)

Hans-Christoph Becker, MD, FSABI, FSCCT
Radiologist
Clinical Professor, Radiology
Michael Khodadoust
Michael Khodadoust
Lymphoma specialist, Cutaneous oncology specialist, Hematologist, Hematologist-Oncologist
Assistant Professor of Medicine (Oncology) and of Dermatology
David B Miklos
David B Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
James and Katherine Lau Professor

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Contact

Physician Referrals
650-723-0822

View on ClinicalTrials.gov