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Clinical Trial 19725

Cancer Type: Malignant Hematology
Interventions:

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

  • Michael Jain

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1/2 Multicenter Study Evaluating the Safety And Efficacy Of Axicabtagene Ciloleucel in Combination with Utomilumab in Subjects with Refractory Large B-Cell Lymphoma (Zuma-11)

Summary

Objective

Primary objective: The primary objective of Phase 1 is to evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2 The primary objective of Phase 2 is to evaluate the efficacy of axicabtagene ciloleucel and utomilumab, as measured by complete response (CR) rate in subjects with refractory large B-cell lymphoma Secondary objectives: Secondary objectives for Phase 1 and Phase 2 will include assessing the safety and tolerability of axicabtagene ciloleucel and utomilumab, additional efficacy endpoints and levels of axicabtagene ciloleucel in blood (PK) and levels of cytokines in serum

Inclusion Criteria

  • Histologically proven large B-cell lymphoma .
  • Chemotherapy-refractory disease.
  • At least 1 measureable lesion according to the Lugano Classification (Cheson et al, 2014). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
  • Participant 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
  • No evidence, suspicion and/or history of central nervous system (CNS) involvement of lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Other criteria may apply

    • Exclusion Criteria

  • Histologically proven primary mediastinal B-cell lymphoma (PMBCL)
  • History of Richter's transformation of chronic lymphocytic lymphoma (CLL)
  • Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
  • History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
  • History of HIV infection or acute or chronic active hepatitis B or C infection. Individuals with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines or applicable country guidelines
  • Individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or a history of CNS lymphoma
  • History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
  • Individuals with cardiac atrial or cardiac ventricular lymphoma involvement
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
  • Requirement for urgent therapy due to tumor mass effects (eg, blood vessel compression, bowel obstruction, or transmural gastric involvement
  • Primary immunodeficiency
  • History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years. 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
  • History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment
  • Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
  • Autologous stem cell transplant within 6 weeks of planned enrollment
  • Prior organ transplantation including prior allogeneic stem cell transplant (SCT)
  • Use of any standard or experimental anti-cancer therapy within 2 weeks prior to enrollment, including cytoreductive therapy and radiotherapy, immunotherapy, or cytokine therapy (except for erythropoietin) Prior treatment with PD-L1 inhibitor, PD-1 inhibitor, anti-CTLA4, anti-CD137 (4-1BB), anti-OX40 or other immune checkpoint blockade or activator therapy
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, 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
  • In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
  • Other exclusions may apply

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