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CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

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

Trial ID or NCT#

NCT02926833

Status

NOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

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

View All Criteria

Investigator(s)

Laura Johnston

Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist

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

Robert Negrin

Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist

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

Wen-Kai Weng, MD, PhD

Blood and marrow transplant specialist, Blood and marrow transplant specialist, Lymphoma specialist, Medical oncologist, Multiple myeloma specialist

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

Robert Lowsky

Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist

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

Andrew Rezvani, M.D.

Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist

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

Michael Khodadoust

Lymphoma specialist, Cutaneous oncology specialist, Hematologist, Hematologist-Oncologist

Assistant Professor of Medicine (Oncology) and of Dermatology

Lori Muffly

Hematologist, Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist-Oncologist

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

CONTACT

CCTO
(650) 498-7061

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

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

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

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To: