NCT07198464尚未招募不适用
A Prospective, Multicenter Clinical Study of Relmacabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation, Orelabrutinib, and Sintilimab for Primary Central Nervous System Lymphoma
未提供0 个研究点目标入组 30 人开始时间: 2025年10月7日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- progression-free survival(PFS)
研究概览
简要总结
To evaluate the efficacy and safety of relmacabtagene autoleucel combined with autologous hematopoietic stem cell transplantation, orelabrutinib, and sintilimab as first-line or relapsed/refractory treatment for primary central nervous system diffuse large B-cell 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18-60 years 2.ECOG performance status 0-2 3.No prior treatment with CAR-T cell therapy or autologous stem cell transplantation (ASCT) 4.Expected survival ≥ 3 months 5.No history of malignancy (except for in situ carcinoma or other indolent malignancies), or inactive malignancy with treatment completed >1 year ago 6.Histopathologically confirmed PCNSL (lymphoma confined to the brain without systemic involvement, with histopathological type being diffuse large B-cell lymphoma, or systemic lymphoma with central nervous system involvement and histopathological type being diffuse large B-cell lymphoma) 7.Refractory disease is defined as failure to achieve complete remission after first-line therapy (excluding intolerance to first-line therapy), including: Progressive disease (PD) as best response to first-line therapy, or Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP), or Residual disease after at least 6 cycles of first-line therapy, or relapse within 12 months after completing first-line therapy 8.Relapsed disease is defined as recurrence after achieving complete remission following first-line therapy, occurring within 12 months after treatment completion 9.Positive CD19 expression by immunohistochemistry 10.No contraindications for CAR-T cell therapy or ASCT 11.No concurrent use of other anti-tumor therapies during this treatment; bisphosphonates for bone metastases and symptomatic supportive treatments are allowed 12.Able to understand the study and provide signed Informed Consent Form
排除标准
- •Pregnant or lactating women
- •Any uncontrolled medical condition (including active infection, uncontrolled diabetes, severe cardiac, hepatic or renal insufficiency, interstitial pneumonia, etc.)
- •Use of systemic corticosteroids within 7 days before CD19 CAR-T cell infusion (except ≤ 5 mg/day dexamethasone or equivalent doses of other corticosteroids)
- •Prior exposure to ≥ 2 of the following agents with documented resistance: orelabrutinib, fotemustine, carmustine, thiotepa, or PD-1/PD-L1 inhibitors
- •History of autoimmune disease
- •Presence of cachexia or any other contraindication to chemotherapy
- •Active, uncontrolled infection
- •History of poorly controlled psychiatric disorder
- •Any condition that, in the opinion of the investigator, would preclude safe participation in this trial
研究组 & 干预措施
relmacabtagene autoleucel and transplantation
Experimental
relmacabtagene autoleucel combined with autologous hematopoietic stem cell transplantation, with orelabrutinib, and sintilimab as maintenance therapy
干预措施: Relmacabtagene autoleucel and transplantation (Drug)
结局指标
主要结局
progression-free survival(PFS)
时间窗: Up to 60 months
PFS is defined as the time from CAR-T infusion to the first occurrence of either disease progression or death from any cause, whichever comes first, regardless of whether study treatment has been discontinued prior to the PFS event.
overall response rate(ORR)
时间窗: Up to 3 months
次要结局
- Overall Survival (OS)(Up to 60 months)
研究者
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