HDM2005 combined with standard treatment for diffuse large B-cell lymphoma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b/2, open-label study that gives HDM2005 together with established rituximab-based chemotherapy regimens and follows a dose-escalation phase followed by a dose-expansion phase. Cohort A enrolls patients with relapsed or refractory DLBCL and receives HDM2005 plus R‑GemOx, while Cohort B enrolls untreated patients (IPI 2–5) and receives HDM2005 plus R‑CHP. Key endpoints include safety, tolerability, and antitumor activity, with eligibility requiring measurable disease and adequate organ function. The study is conducted at three cancer centers in China and monitors patients for adverse events and tumor response during and after treatment.

Why it matters

Who can join: the full rules

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.
4. History of severe bleeding disorders.
5. History of interstitial lung disease or radiation pneumonitis.
6. Prior solid organ transplant.
7. Ongoing Grade \>1 treatment-related adverse events.
8. Current or history of clinically significant cardiovascular and cerebrovascular diseases.
9. Active infection requiring systemic therapy.
10. Concurrent active HBV or HCV infection or known history of human immunodeficiency virus (HIV) infection.
11. Prior ROR1-targeted therapy.
12. Ongoing corticosteroid therapy.
13. Current active autoimmune disease or history of autoimmune disease requiring treatment.
14. History of drug anaphylaxis or severe food allergy.
15. Any history or current evidence of disease, treatment, or laboratory abnormality as determined by the investigator that may affect the study results, interfere with the subject's full participation in the study, or be contrary to the subject's best interests.

Where it's running

• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Not yet recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Not yet recruiting
• The Affiliated Tumor Hospital of Guangxi Medical University
  Nanning, Guangxi, China Not yet recruiting
• Affiliated Tumor Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Not yet recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Not yet recruiting

Study contacts

• Study coordinator: Meiping Kong
• Email: cxykongmeiping@eastchinapharm.com
• Phone: +8613735478976

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.