A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

This is an interventional treatment trial for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma focused on measuring CD19/CD20-directed CAR-T Cells Read More

Inclusion Criteria

• ≥ 18 years of age, at the time of signing informed consent

• Diagnosis of aggressive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms:

  1. Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
  2. Primary mediastinal large B-cell lymphoma (PMBCL)
  3. Transformed follicular lymphoma (tFL)
  4. High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
  5. High-grade B-cell lymphoma, NOS
  6. Follicular lymphoma grade 3B (FL3B)
• Histologically confirmed CD19 or CD20 positive disease by immunohistochemistry test result and corresponding pathology report

• Relapsed or refractory disease after ≥ 2 lines of standard therapy and having relapsed within 12 months of receipt of the most recent anti-lymphoma treatment

  a) For patients with DLBCL, PMBCL, high-grade B-cell lymphomas, tFL and FL grade 3B, patients must have been treated with a line of therapy with an anthracycline and a line of therapy with an anti-CD20 targeted agent

• Measurable disease per the Lugano 2014 Classification, having at least one measurable lesion defined as:

  1. Nodal lesion with longest diameter ≥ 1.5 cm
  2. Extranodal lesion with longest diameter ≥ 1.0 cm
• ECOG performance status of either 0 or 1 at screening
• Adequate bone marrow, liver, renal and cardiopulmonary function

Exclusion Criteria

• HHV8-positive DLBCL
• Prior allogeneic HSCT
• Autologous stem cell transplant within 12 weeks of CAR T cell infusion
• Inadequate wash-out time for previous anti-tumor treatments prior to C-CAR039 infusion
• Received a live vaccine within 4 weeks of leukapheresis
• Uncontrolled active HIV, HBC, or HCV infection
• History of deep vein thrombosis or pulmonary embolism within six months of infusion (line associated DVT is allowed)
• History of stroke, unstable angina, myocardial infarction, congestive heart failure (NYHA Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening
• History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease
• Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
• Active CNS involvement by malignancy
• Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment)
• Previous (within 5 years) or concurrent malignancy except for basal cell or squamous cell carcinoma or In situ carcinoma of the cervix or breast in complete remission
• Pregnant or lactating women
• Allergies to concomitant drugs used in this study or C-CAR039 cell product
• Other co-morbid condition or disease that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial