Key Inclusion Criteria:
1. Have documented CD20+ B-cell malignancy, with active disease not responsive to prior
therapy, for whom no standard of care options exists, and for whom treatment with an
anti-CD20 antibody may be appropriate.
2. Patients with NHL must have had prior treatment with an anti-CD20 antibody therapy.
Patients with CLL are not required to have received prior treatment with an anti-CD20
antibody therapy, provided the patient has failed either a BTK inhibitor or PI3K
inhibitor and the treating physician deems it appropriate for the patient to be
entered into a phase 1 trial.
- • For inclusion in the FL grade 1-3a expansion cohort, patients must have received
at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and
an alkylating agent.
- • For the inclusion in the disease-specific expansion cohort enrolling DLBCL
patients after failure of CAR-T therapy, the patient must have recovered from the
toxicities of the lymphodepletion therapy and CAR-T infusion.
3. Must have at least one bi-dimensionally measurable lesion =1.5 cm) documented by CT or
4. Eastern Cooperative Oncology Group (ECOG) performance status =1
5. Life expectancy of at least 6 months
6. Adequate bone marrow function documented by:
1. Platelet counts =75 x 10^9/L
2. Hb level =9 g/dL
3. Absolute neutrophil count (ANC) =1 x 10^9/L
7. Adequate organ function documented by:
1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 X ULN
2. Total bilirubin =1.5 X ULN
3. Calculated creatinine clearance by Cockcroft-Gault =50 mL/min (patients with
borderline creatinine clearance by Cockcroft-Gault may be considered for
enrollment if a measured creatinine clearance (based on 24-hour urine or other
reliable method) is =50 mL/min)
8. Willing and able to comply with clinic visits and study-related procedures
9. Provide signed informed consent
Key Exclusion Criteria:
1. Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by
non-primary CNS NHL
2. History of or current relevant CNS pathology
3. Allogeneic stem cell transplantation
4. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis
B virus (HBV) or hepatitis C virus (HCV). Patients with hepatitis B (HepBsAg+) who
have controlled infection (serum hepatitis B virus DNA that is below the limit of
detection AND receiving anti-viral therapy for hepatitis B) are permitted upon
consultation with the physician managing the infection.
5. Known hypersensitivity to both allopurinol and rasburicase
6. History of hypersensitivity to any compound in the tetracycline antibiotics group
The information provided above is not intended to contain all considerations relevant to
potential participation in a clinical trial therefore not all inclusion/ exclusion criteria