About this trial
The purpose of this phase 1b/2 study is to evaluate the safety, tolerability, and antitumor activity of HDM2005 in combination with standard of care in participants with diffuse large B-cell lymphoma. This study will include two arms: Cohort A (HDM2005 + R-GemOx) will enroll participants with relapsed/refractory DLBCL. Cohort B (HDM2005 + R-CHP) will enroll participants with untreated DLBCL. The study will consist of two parts: dose-escalation part and dose-expansion part.
Eligibility criteria
Qualifiers
Male or female aged 18-75 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy >12 weeks.
Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
Disqualifiers
Known active central nervous system (CNS) lymphoma.
Prior of allogeneic hematopoietic stem cell transplantation and has acute or ongoing graft-versus-host disease (GVHD) of any grade.
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
History of severe bleeding disorders.
Trial design
Treatments tested in this trial
- HDM2005
- Rituximab or Rituximab biosimilar
- Gemcitabine
- Oxaliplatin
- Cyclophosphamide
- Doxorubicin
- Prednisone