A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- The complete response rate (CRR) at 3 months
研究概览
简要总结
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma
详细描述
Relmacabtagene Autoleucel treatment: Patients will receive intravenous fludarabine (25 mg/m²/day for 3 days) and cyclophosphamide (250 mg/m²/day for 3 days) for lymphodepletion, with adjustments based on hematologic and renal function.Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion.
Sintilimab treatment: Patients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.
Primary endpoint: The complete response rate (CRR) at 3 months.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be aware of and voluntarily sign the informed consent form (ICF).
- •Aged between 18 and 70 years, both male and female.
- •Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is CD19-negative).
- •The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.
- •Relapsed/refractory DLBCL, FL, or MCL.
- •At least one measurable or evaluable lesion.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Expected survival of ≥3 months.
- •Adequate function of the heart, lungs, liver, kidneys, and other organs.
排除标准
- •History of another malignancy that has not been in complete remission for at least 2 years, except for: non-melanoma skin cancer, completely resected stage I tumors with low recurrence potential, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or squamous intraepithelial lesions detected by Pap smear and so on.
- •Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit of the reference value can be included.
- •Hepatitis C, HIV, or syphilis infection.
- •Uncontrolled systemic fungal, bacterial, viral, or other infections.
- •Acute or chronic graft-versus-host disease (GVHD).
- •Known hypersensitivity or allergy to any study drug or excipient.
- •Clinically significant central nervous system (CNS) disease or symptoms, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric illness.
- •Pregnant or breastfeeding women, and women of childbearing age who do not wish to use contraception.
- •Mentally ill individuals or those unable to provide informed consent.
- •The investigator deems the patient unsuitable for the study due to medical, psychological, familial, social, or geographical reasons or an inability to comply with the study protocol.
- •Previous CAR-T cell therapy or other gene-modified T-cell treatments.
- •Previous CD19-targeted therapy.
- •Previous allogeneic hematopoietic stem cell transplantation.
研究组 & 干预措施
Relmacabtagene Autoleucel in combination with Sintilimab
Patients with CD19-positive relapsed/refractory B-cell lymphoma will receive Relmacabtagene Autoleucel after lymphodepletion therapy (fludarabine + cyclophosphamide) on Day 1. After Relmacabtagene Autoleucel infusion, sintilimab (200 mg IV) will begin on Day 28, administered every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 1 year.
干预措施: Autoleucel (Relmacabtagene Autoleucel) (Drug)
Relmacabtagene Autoleucel in combination with Sintilimab
Patients with CD19-positive relapsed/refractory B-cell lymphoma will receive Relmacabtagene Autoleucel after lymphodepletion therapy (fludarabine + cyclophosphamide) on Day 1. After Relmacabtagene Autoleucel infusion, sintilimab (200 mg IV) will begin on Day 28, administered every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 1 year.
干预措施: Sintilimab (PD-1 inhibitor) (Drug)
结局指标
主要结局
The complete response rate (CRR) at 3 months
时间窗: Up to 3 months after Relmacabtagene Autoleucel infusion
次要结局
- Overall survival (OS)(From the date of enrollment until the date of death from any cause, assessed up to 24 months)
- Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0(Through study completion, an average of 2 years)
- Objective Response Rate(Up to 1 year after Relmacabtagene Autoleucel infusion)
- Disease-free survival (DFS)(From the date of the first complete response to the date of the first documented progression or death from any cause, whichever came first,assessed up to 24 months)
- Progression-free survival (PFS)(From the date of enrollment until the date of the first documented progression or death from any cause,whichever came first,assessed up to 24 months)
研究者
Qingqing Cai
chief physician
Sun Yat-sen University