Trial Search Results

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

The sponsors are testing an investigational treatment including two experimental drugs named KTE-C19 and Atezolizumab. The main purpose of this research study is to determine if the investigational products, KTE-C19 and Atezolizumab, when used concurrently and administered after participants receive a 3 day course of chemotherapy, is safe and effective in treating non-Hodgkin B-cell lymphoma and standard therapies available to treat the disease have not been effective.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Kite, A Gilead Company

Collaborator: Genentech, Inc.

Intervention(s):

  • Biological: axicabtagene ciloleucel
  • Biological: atezolizumab (anti-PD-L1)
  • Drug: Cyclophosphamide
  • Drug: Fludarabine

Phase:

Phase 1/Phase 2

Eligibility


Key Inclusion Criteria:

   1. Histologically confirmed:

      - Diffuse Large B Cell Lymphoma (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 IWG Response Criteria

   5. Age 18 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 IRB/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 CNS involvement

   8. History of autoimmune disease. Patients with a history of autoimmune-related
   hypothyroidism on a stable dose of thyroid replacement hormone and patients 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 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting