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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 97 participants in total. It began in 2025-07-30 with a primary completion date of 2027-10-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07124936 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Diffuse Large B Cell Lymphoma (DLBCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07124936 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07124936 currently recruiting?
Yes, NCT07124936 is actively recruiting participants. Contact the research team at cxykongmeiping@eastchinapharm.com for enrollment information.
Where is the NCT07124936 trial being conducted?
This trial is being conducted at Beijing, China, Fuzhou, China, Guangzhou, China, Nanning, China and 11 additional locations.
Who is sponsoring the NCT07124936 clinical trial?
NCT07124936 is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. The trial plans to enroll 97 participants.