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

Summary

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.

Conditions

• Refractory Diffuse Large B Cell Lymphoma (DLBCL)
• Relapsed Diffuse Large B-Cell Lymphoma
• Transformed Follicular Lymphoma (TFL)
• Primary Mediastinal B-cell Lymphoma (PMBCL)
• High Grade B-cell Lymphoma (HGBCL)

Interventions

BIOLOGICAL

Axicabtagene Ciloleucel

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

DRUG

Fludarabine

Administered according to package insert

DRUG

Cyclophosphamide

Administered according to package insert

DRUG

Levetiracetam

Administered according to package insert

DRUG

Tocilizumab

Administered according to package insert

DRUG

Dexamethasone

Administered according to package insert

DRUG

High-dose methylprednisolone

Administered according to package insert

DRUG

Bendamustine

Administered according to package insert

DRUG

Rituximab

Administered according to package insert

DRUG

Doxorubicin

Administered according to package insert

DRUG

Prednisone

Administered according to package insert

DRUG

Vincristine

Administered according to package insert

DRUG

Ifosfamide

Administered according to package insert

DRUG

Carboplatin

Administered according to package insert

DRUG

Etoposide

Administered according to package insert

DRUG

Gemcitabine

Administered according to package insert

DRUG

Oxaliplatin

Administered according to package insert

DRUG

Cisplatin

Administered according to package insert

DRUG

Methylprednisolone

Administered according to package insert

Sponsors & Collaborators

• Kite, A Gilead Company

  lead INDUSTRY

Principal Investigators

• Kite Study Director · Kite, A Gilead Company

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-21

Primary Completion

2023-07-27

Completion

2023-07-27

FDA Drug

Yes

Countries

• United States
• Canada
• France
• Germany
• Israel
• Netherlands

Study Locations