NCT06375733 A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL
| NCT ID | NCT06375733 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Genfleet Therapeutics (Shanghai) Inc. |
| Condition | Large B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including: DLBCL, not specified (NOS), T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL), high-grade B-cell lymphoma, or large B-cell lymphoma transformed from indolent B-cell lymphoma (including but not limited to Richter syndrome, transformed follicular lymphoma, transformed MZL) (2016 WHO classification). 3. Relapse or refractory after receiving 2\~4 systemic treatment regimens, at least one of which contains anthracyclines and Rituximab. 4. Must have a measurable lesion. 5. The patient is not suitable to receive stem cell transplantation judged by the investigator. 6. The Eastern Cooperative Oncology Group (ECOG) performance status score (PS) is 0\~2. 7. Have adequate organ function, including: i. Hematopoietic function: absolute neutrophil count (ANC) ≥1.0×109/L, platelet count (PLT) ≥75×109/L and hemoglobin (Hgb) ≥ 80 g/L. ii. Liver function: total bilirubin ≤ 1.5 × up