NCT07124936 A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma
| NCT ID | NCT07124936 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
| Condition | Diffuse Large B Cell Lymphoma (DLBCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 97 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2027-10-26 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: 1. Male or female aged 18-75 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Life expectancy \>12 weeks. 4. Histologically confirmed diffuse large B-cell lymphoma (DLBCL). a. Cohort B: International Prognostic Index (IPI) score of 2-5. 5. Prior treatment: 1. Cohort A: At least one (≥1) line of prior systemic therapy. 2. Cohort B: Has received no prior treatment for DLBCL. 6. At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed tomography (CT) scan. 7. Adequate organ system and hematologic function as defined in protocol. Exclusion Criteria: 1. Known active central nervous system (CNS) lymphoma. 2. Prior of allogeneic hematopoietic stem cell transplantation and has acute or ongoing graft-versus-host disease (GVHD) of any grade. 3. Known additional malignancy that is progressing or has required active treatment within the past 3 years.