Clinical Trial 17967

Cancer Type: Malignant Hematology
Interventions:Axicabtagene Ciloleucel (KTE-C19); KTE-C19; Levetiracetam; Tocilizumab; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

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


    Study Title

    A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL)


    The purpose of this study is to determine if the experimental product, KTE‐C19, when administered after participants receive either a 3 or 7 day course of chemotherapy, is safe and effective in treating their disease.


    The Primary Objective of phase 1 is to evaluate the safety of KTE-C19. The Primary Objective of phase 2 is to evaluate the efficacy of KTE-C19, as measured by objective response rate in subjects with DLBCL, PMBCL, and TFL. Secondary Objectives will include assessing the safety and tolerability of KTE-C19 and additional efficacy endpoints.

    Inclusion Criteria

  • Age 18 years or older
  • Histologically confirmed: Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal Large B Cell Lymphoma (PMBCL); Transformation Follicular Lymphoma (TFL
  • Chemotherapy- refractory disease , defined as one or more of the following: Stable disease (duration of stable disease must be less than or equal to 12 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 SCT.
  • 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; for subjects with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL.
  • At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Absolute neutrophil count (ANC) ≥ 1000/uL
  • Platelet count ≥ 75,000/uL
  • Absolute lymphocyte count ≥100/uL
  • Adequate renal, hepatic, pulmonary and cardiac function
  • Women of childbearing potential must have a negative serum or urine pregnancy test.
  • All participants or legally appointed representatives/caregivers, must personally sign and date the IRB/IEC approved consent form before initiating any study specific procedures or activities.

  • Exclusion Criteria

  • 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
  • Autologous stem cell transplant within 6 weeks of planned KTE‐C19 infusion
  • History of allogeneic stem cell transplantation
  • Prior chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy
  • Clinically significant active infection (e.g. Simple UTI, bacterial pharyngitis allowed) or currently receiving IV antibiotics or have received IV antibiotics within 7 days prior to enrollment. Prophylaxis antibiotics, antivirals and antifungals are permitted.
  • Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
  • Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port‐a‐Cath or Hickman catheter are permitted.
  • Detectable cerebrospinal fluid malignant cells or brain metastases or 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 central nervous system (CNS) involvement.