NCT05400876Unknown1 期
Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab in Patients With Relapsed or Refractory Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- dose limiting toxicity/DLT
研究概览
简要总结
This is a two-phase, open-label Phase Ib clinical trial to evaluate the safety and efficacy of TQB2618 injection combined with Penpulimab in patients with relapsed and refractory lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 Subjects with pathologically proven with relapsed or refractory lymphoma and with disease progression during or after the last treatment or no objective response confirmed after adequate treatment.
- •2 Cohort 1: Subjects with Classical Hodgkin lymphoma (cHL) who had previously received at least twice systemic therapy and are resistant to PD-1 or PD-L
- •3 Cohort 2: Subjects with B lymphocyte non-Hodgkin lymphoma (B-NHL) who had previously received at least twice systemic therapy containing anti-CD20-targeted therapy.
- •4 Cohort 3：Subjects with T lymphocyte non-Hodgkin lymphoma (T-NHL) who had previously received at least one systemic therapy.
- •5 Subjects with measurable lesions as defined by Lugano
- •6 Aged 18-75 years ; Eastern Cooperative Oncology Group (ECOG) score:0 ~ 1; Expected survival ≥3 months.
- •7 Laboratory indicators meet the requirements.
- •8 Subjects voluntarily joined the study and signed the informed consent form.
- •9 Non-pregnant or non-breastfeeding women; Negative pregnancy subjects.
排除标准
- •1 Subjects who have developed or is currently suffering from other malignancies within 3 years, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ.
- •2 Subjects who have not recovered to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to the adverse event of prior therapy.
- •3 Subjects with significant surgery or significant traumatic injury within 28 days before first injection (excluding needle biopsy or endoscopic biopsy).
- •4 Subjects with long-term unhealed wounds or fractures.
- •5 Subjects with the high risk of bleeding or bleeding history or subjects with bleeding event (≥Common Terminology Criteria for Adverse Events Grade 3) within 4 weeks before first injection.
- •6 Subjects with arterial/venous thrombosis within 6 months.
- •7 Subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders.
- •8 Subjects with any severe and/or uncontrolled disease.
- •9 subjects with lymphoma originating from Central Nervous System, high-grade B-cell lymphoma or hemophagocytic syndrome during screening period.
- •10 Subjects with violating Central Nervous System (CNS) .
- •11 Subjects with allogeneic hematopoietic stem cell transplantation.
- •12 Subjects with autologous hematopoietic stem cell transplantation or Chimeric Antigen Receptor T-Cell Immunotherapy(CAR-T) within 3 months before first injection.
- •13 Subjects with other factors that might cause the study to be terminated halfway per the judgement of the investigator.
研究组 & 干预措施
TQB2618 injction+penpulimab injection
Experimental
TQB2618 injection with penpulimab injection, 21 days as a treatment cycle
干预措施: TQB2618 injection (Drug)
TQB2618 injction+penpulimab injection
Experimental
TQB2618 injection with penpulimab injection, 21 days as a treatment cycle
干预措施: Penpulimab injection (Drug)
结局指标
主要结局
dose limiting toxicity/DLT
时间窗: From the first injection up to 3 weeks
The relevant adverse reactions occurred within the first cycle
recommended phase II dose/RP2D
时间窗: From the first injection up to 6 weeks
The dose of TQB2618 injection which is recommended to use during phase II clinical trial
Overall response rate (ORR) based on 2014 Lugano
时间窗: From the first injection up to 96 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
次要结局
- Peak time/Tmax(Cycle 1 day 1 Before administration, 30 minuets,4,8,24,48,144,312 hours after minuets, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before and 30 minutes after administration.each cycle 21 days)
- Peak concentration (Cmax)(Cycle 1 day 1 Before administration, 30 minuets,4,8,24,48,144,312 hours after minuets, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before and 30 minutes after administration.（each cycle 21 days）)
- Receptor Occupancy/RO(Cycle 1 day 1, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before administration and 30 minutes after administration and the day of disease progression（each cycle 21 days))
- Duration of Response (DOR)(From the first injection up to 120 weeks)
- Progression-free survival (PFS)(Up to 96 weeks)
- Overall survival/OS(From date of randomization until the death from any cause, assessed up to 120 weeks)
- complete remission rate/CRR(From the first injection up to 96 weeks)
- Half-life /T1/2(Cycle 1 day 1 Before administration, 30 minuets,4,8,24,48,144,312 hours after minuets, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before and 30 minutes after administration.（each cycle 21 days))
- Incidence of Anti-Drug antibody and neutralizing antibodies(Cycle 1 day 1, Cycle 2 day 1, Cycle 4 day 1, Cycle 8 day 1,before administration and 30, 90 days after the last administration（each cycle 21 days))
- Adverse event rate(Baseline up to 96 weeks)
- Disease control rate/DCR(From the first injection up to 96 weeks)
研究者
研究点 (1)
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