Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Not Recruiting

Trial ID: NCT02926833

Purpose

The primary objective of phase 1 is to evaluate the safety of KTE-C19 and atezolizumab combination regimens. The primary objective of phase 2 is to evaluate the efficacy of KTE-C19 and atezolizumab, as measured by complete response rate in participants with refractory diffuse large B-cell lymphoma (DLBCL). 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 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Subjects With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Stanford Investigator(s)

Andrew Rezvani, M.D.
Andrew Rezvani, M.D.

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Michael Khodadoust
Michael Khodadoust

Assistant Professor of Medicine (Oncology) and of Dermatology

Lori Muffly
Lori Muffly

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Eligibility


Key Inclusion Criteria:

   1. Histologically confirmed DLBCL

   2. Chemotherapy-refractory disease, defined as one or more of the following:

      - Stable disease (duration of stable disease must be less than or equal to 6
      months) or progressive disease as best response to most recent chemotherapy
      containing regimen

      - Disease progression or recurrence less than or equal to 12 months of prior
      autologous stem cell transplantation (SCT)

   3. Individuals must have received adequate prior therapy including at a minimum:

      - anti-CD20 monoclonal antibody unless investigator determines that tumor is
      CD20-negative; and

      - an anthracycline containing chemotherapy regimen

   4. At least one measurable lesion per revised International Working Group (IWG) Response
   Criteria

   5. Age 18 years or older

   6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1

   7. Adequate organ and bone marrow function

   8. All individuals or legally appointed representatives/caregivers, must personally sign
   and date the institutional review board (IRB)/independent ethics committee (IEC)
   approved consent form before initiating any study specific procedures or activities.

Key Exclusion Criteria:

   1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g.,
   cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3
   years

   2. History of allogeneic stem cell transplantation

   3. Prior CAR therapy or other genetically modified T cell therapy

   4. Clinically significant active infection

   5. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C
   virus (anti-HCV positive)

   6. Individuals with detectable cerebrospinal fluid malignant cells or brain metastases or
   with a history of cerebrospinal fluid malignant cells or brain metastases

   7. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia,
   cerebellar disease, or any autoimmune disease with central nervous system (CNS)
   involvement

   8. History of autoimmune disease. Participants with a history of autoimmune-related
   hypothyroidism on a stable dose of thyroid replacement hormone and participants with
   controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible for
   this study.

   9. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
   obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active
   pneumonitis per chest computed tomography (CT) scan at screening. History of radiation
   pneumonitis in the radiation field (fibrosis) is allowed.

10. Prior treatment with PD-L1 inhibitor, PD-1 inhibitor, anti-CTLA4, anti-CD137,
   anti-OX40 or other immune checkpoint blockade or activator therapy with the exception
   of Individuals who received atezolizumab in this study and are eligible for
   re-treatment

11. Prior CD19 targeted therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Intervention(s):

drug: Cyclophosphamide

drug: Fludarabine

biological: KTE-C19

biological: Atezolizumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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