A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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

Treatment groups

97 Participants
are divided into 2 treatment groups