Clinical Trial 18289

Cancer Type: Malignant Hematology
Interventions:KTE-C19

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Frederick Locke

Overview

Study Title

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL)

Summary

The purpose of this study is to determine if the experimental product, KTE‐C19, when administered after participants receive a 3 day course of chemotherapy, is safe and effective in treating their Mantle Cell Lymphoma (MCL).

Objective

The Primary Objective is to evaluate the efficacy of KTE-C19, as measured by objective response rate, in subjects with r/r MCL. Secondary Objectives will include assessing the safety and tolerability of KTE-C19 and additional efficacy endpoints.

Inclusion Criteria

  • Pathologically confirmed Mantle Cell Lymphoma (MCL), with documentation of either overexpression of cyclin D1 or presence of translocation t.
  • Up to 5 prior regimens for MCL. Prior therapy must have included: Anthracycline or bendamustine-containing chemotherapy; and Anti-CD20 monoclonal antibody therapy; and Ibrutinib.
  • Relapsed or refractory disease, defined by the following: Disease progression after last regimen, or Refractory disease is defined failure to achieve a Partial Response (PR) or Complete Response (CR) to the last regimen.
  • At least 1 measurable lesion according to the revised International Working Group ( IWG) Response Criteria for Malignant Lymphoma.
  • Age 18 years or older.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Absolute neutrophil count (ANC) ≥ 1000/uL .
  • Platelet count ≥ 75,000/uL .
  • Adequate renal, hepatic, pulmonary and cardiac function.
  • Females of childbearing potential must have a negative serum or urine pregnancy test.
  • Additional criteria may apply.

  • Exclusion Criteria

  • History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease free for at least 3 years.
  • History of allogeneic stem cell transplantation.
  • Prior CD19 targeted therapy.
  • Prior chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.
  • Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
  • A detectable cerebrospinal fluid malignant cells or brain metastases or a history of cerebrospinal fluid malignant cells or brain metastases.
  • History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement.
  • Additional criteria may apply.