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

Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of KTE-C19 in subjects with Relapsed/Refractory Mantle Cell Lymphoma

Cancer (Oncology), Cancer (Oncology) - Lymphoma
John Pagel, MD, PhD

Swedish Cancer Institute

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Pathologically confirmed MCL
  • 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 PR or CR to the last regimen
  • At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma
  • Age 18 years or older
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  • ANC ≥ 1000/µL
  • Platelet count ≥ 50,000/µL
  • Adequate renal, hepatic, and cardiac function defined as:

    • Serum creatinine ≤ 1.5 mg/dL
    • Serum ALT/AST ≤ 2.5 ULN
    • Total bilirubin ≤ 1.5 mg/dL, except in subjects with Gilbert's syndrome.
    • Cardiac ejection fraction ≥ 50% (by ECHO) and no evidence of pericardial effusion as determined by an ECHO.

Key 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 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)
  • Subjects with detectable cerebrospinal fluid malignant cells or brain metastases or with 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 CNS involvement
(206) 215-3086