An Open-label, Single-arm, and Multicenter Phase Ⅱ Study to Evaluate the Efficacay and Safety of F520 Combined With F007 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Overview
- Phase
- Phase 2
- Intervention
- F520+F007
- Conditions
- RR DLBCL; PD-1; CD20
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Enrollment
- 62
- Primary Endpoint
- 1. Objective response rate (ORR)
- Last Updated
- 4 years ago
Overview
Brief Summary
This is an open-label, single-arm, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of F520 (PD-1) combined with F007(rituximab biosimilar) in patients with Relapsed/Refractory diffuse large B-cell lymphoma. About 62 patients with relapsed/refractory DLBCL plan to be enrolled in about 8 study sites of the study.
Primary objective:
The purpose is to evaluate the objective response rate of F520 combined with F007 in Relapsed/Refractory diffuse large B-cell lymphoma.
Secondary objective:
The purpose is to compare the safety of F520 combined with F007 in Relapsed/Refractory diffuse large B-cell lymphoma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged ≥18 and ≤80 years old.
- •CD20-positive relapsed/refractory DLBCL (≥ 2 prior lines of therapy )
- •Recurrence: Relapse occurred more than 6 months after the end of treatment. At least one regimen contains Rituximab.
- •Refractory: Relapse within 6 months after the end of treatment or fail to reach PR after 2 treatment cycles and fail to reach CR after 4 treatment cycles. At least one regimen contains Rituximab.
- •Recurrence after second-line treatment sequential autologous hematopoietic stem cell transplantation.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •More than 3 months life expectancy.
- •Those who agree to provide archived tumor tissue samples or fresh tissue samples
- •Biopsy confirmed CD20-positive after the last treatment. Recurrence more than 1 year needs to undergo tissue biopsy to confirm the pathological diagnosis.
- •Adequate cardiac function (LVEF≥50%).
Exclusion Criteria
- •Primary mediastinal (thymic) large B-cell lymphoma.
- •Transformed lymphoma.
- •DLBCL invaded by special parts, such as central nervous system (CNS), testis, breast, ovary, etc.
- •High-grade B-cell lymphoma with MYC, BCL2 and/or BCL6 rearrangement.
- •History of other malignancies (except for basal/squamous cell carcinoma of the skin, in-situ carcinoma of the cervix or breast, superficial bladder cancer, lung carcinoma in situ that have been cured for more than 5 years).
- •Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV-DNA titer higher than 2000 IU/mL or 1000 copies) or hepatitis C virus (HCV). Treponema pallidum (TP) antibody positive.
- •Received systemic anticancer therapy include radiation, targeted therapy, or any other anticancer therapy within 3weeks or 5 half-lives before the first administration.
- •Participation in another clinical trial in the past 4 months.
- •Received allogeneic stem cell transplantation.
- •Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody or other medications that stimulates or collaboratively inhibits T cell receptors or CAR-T.
Arms & Interventions
F520+F007
Treatment period： F007 (375 mg/m2) administered intravenously (IV) on Day 1 of each 14-day cycle for 8 cycles. F520 (200mg) administered intravenously (IV) on Day 2 of each 14-day cycle for cycle 1. F520 (200mg) administered intravenously (IV) on Day 1 of each 14-day cycle for cycle 2 to 8. Maintenance period： F007 (375 mg/m2) administered intravenously (IV) on Day 1 of each 56-day cycle for 10 cycles. F520 (200mg) administered intravenously (IV) on Day 1/15/29/43 of each 56-day cycle for 10 cycles.
Intervention: F520+F007
Outcomes
Primary Outcomes
1. Objective response rate (ORR)
Time Frame: 16 weeks
To evaluate the objective response rate in patients with relapsed or refractory DLBCL.
Secondary Outcomes
- 1. Complete response rate (CRR)(16 weeks)
- 2. Progression-free survival (PFS)(2 years)
- 3. Duration of remission (DOR)(2 years)
- 4. Time to progression (TTP)(2 years)
- 5. Overall survival (OS)(2 years)