A Study of C-CAR039 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

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 (archived biopsy tissue or fresh biopsy required).
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

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