A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma focused on measuring CD19/CD20-directed CAR-T Cells
Eligibility Criteria
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:
- Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
- Primary mediastinal large B-cell lymphoma (PMBCL)
- Transformed follicular lymphoma (tFL)
- High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
- High-grade B-cell lymphoma, NOS
- 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:
- Nodal lesion with longest diameter ≥ 1.5 cm
- 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
Sites / Locations
- City of HopeRecruiting
Arms of the Study
Arm 1
Experimental
JNJ-90014496
Participants will receive intravenous (IV) infusion of autologous JNJ-90014496 on Day 1.