A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This is an open-label, single arm, and registered study. About 60 patients with relapsed/refractory DLBCL plan to be enrolled in about 10 study sites of the study. It is planned that at least 50% (~30 patients) will have the GCB subtype of DLBCL. Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. Patients should remain on the study treatment of ATG-010, until either PD or occurrence of unacceptable toxicity.

Inclusion criteria

• The patient must provide informed consent form (ICF) prior to the first screening procedure.
• Age ≥18 years.
• ECOG performance status of ≤ 2.
• Patients should have estimated life expectancy of >3 months at study entry.
• Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
• Patients must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL.
• Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
• Patients must have measurable disease per the revised criteria for response assessment of lymphoma (Cheson, 2014).
• Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue.

Exclusion criteria

• Patients who are pregnant or lactating.
• DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma +NHL), or DLBCL transformed from diseases other than indolent NHL or Richter's.
• Primary mediastinal (thymic) large B-cell lymphoma.
• Known central nervous system lymphoma or meningeal involvement.
• Patients whose most recent systemic anticancer therapy include radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids < 6 weeks prior to first dose of study drug.
• Patients who have not recovered to Grade ≤ 1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy.
• Patients with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation.
• Major surgery within 2 weeks of first dose of study treatment of ATG-010.
• Any life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
• Active hepatitis B virus or hepatitis C virus infection.
• Known human immunodeficiency virus infection.