NCT05320081Unknown2 期
Camrelizumab Combined With CD30 CAR-T in the Treatment of Relapsed/Refractory CD30+ Lymphoma: a Single-arm, Open-label Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- overall response rate
研究概览
简要总结
The is a phase II, single-arm, open-label clinical study assessing the efficacy and safety of Camrelizumab combined with CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 30 subjects with r/r CD30+ lymphoma。
详细描述
This study intends to combine CD30 CAR-T (provided by Wuhan Bio-Raid Biotechnology Co., Ltd) and Camrelizumab (provided by Jiangsu Hengrui Pharmaceutical Co., Ltd.) to treat r/r CD30+ lymphoma, to observe the safety and effectiveness of the combined treatment, and to study the effect of PD-1 antibody on the pharmacokinetics and pharmacodynamics of CAR-T. Obtain a better treatment plan and provide a new strategy for the treatment of clinically r/r CD30+ 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥18 years and ≤70 years，female and male；
- •ECOG performance status 0-2；
- •Histological or flow cytometry confirmed CD30+ lymphoma [according to WHO2008 diagnostic standard]
- •Patients with CD30+ lymphoma relapsed after ≥2 lines of systemic treatment (the disease progresses after treatment remission) or refractory ( failed to obtain CR after previous systemic treatment)；
- •The patient did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) and other anti-cancer treatments within 4 weeks before enrollment, and the treatment-related toxicity has recovered to ≤ Grade 1 (except for alopecia) 4 weeks before enrollment；
- •At least 1 evaluable or measurable lesion can be measured according to the LYRIC 2016 evaluation criteria for malignant lymphoma ；
- •Sufficient organ and bone marrow function, no serious abnormalities neither in hematopoietic function nor in heart, lung, liver, and kidney functions, and no immune deficiencies;
- •The absolute value of neutrophils is ≥1.5×109/L (for patients with bone marrow invasion ≥1.0×109/L);
- •Platelets ≥75×109/L (patients with bone marrow invasion ≥50×109/L);
- •Hemoglobin ≥9 g/dL;
- •Serum creatinine ≤ 1.5× the upper limit of normal (ULN), or creatinine clearance ≥40 mL/min (estimated based on the Cockcroft-Gault formula);
- •Serum total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN ( liver invasion);.
- •f) Aspartate aminotransferase、Alanine Aminotransferase (ALT) ≤2.5 × ULN or ≤5 × ULN ( liver invasion);
- •Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (the PT and APTT should be within the expected range of anticoagulant therapy at the time of screening if the subject is receiving anticoagulant therapy,).
- •Thyroid-stimulating hormone (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) are within ±10% of the normal value.
- •Left ventricular ejection fraction (LVEF) ≥ 50%, no serious malignant arrhythmia;
- •The estimated survival time ≥6 months;
- •Sufficient understanding and voluntarily to sign the informed consent form;
- •Patients with fertility must be willing to be able to use reliable contraceptive measures during the clinical study and within 12 months after the last administration
排除标准
- •Lymphoma associated hemophagocytic syndrome;
- •Patients diagnosed as primary cutaneous anaplastic large cell lymphoma （ALCL） (patients can be enrolled if ALCL is transformed from other organ involvement);
- •Patients with malignant T cells involving bone marrow or peripheral blood;
- •Suffered from other malignant tumors in the past 5 years, except for for skin basal cell carcinoma, skin squamous cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ undergoing the radical treatment
- •Received CAR-T therapy or other genetically modified cell therapy before screening
- •Received other treatments that affect the collection of T cells for when enrolled or within 4 weeks before enrollment;
- •Suffer from active autoimmune diseases that require systemic treatment in the past two years (hormone replacement therapy is not considered as systemic treatment, such as type I diabetes, hypothyroidism that requires only thyroxine replacement therapy, patients with low adrenal function or hypopituitarism who need only physiological doses of glucocorticoid replacement therapy);
- •Patients with uncontrolled infectious diseases, active viral hepatitis, tuberculosis, and HIV-infected ;
- •Known to be allergic to ampicillin, antibodies, cytokines, anti-PD-1/PD-L1 antibodies or pharmaceutical excipients; or have severe allergic reactions to other monoclonal antibodies;
- •Previous use of immunosuppressive drugs within 14 days before the first use of the drug, excluding nasal sprays and inhaled corticosteroids or physiological doses of systemic steroid hormones (ie not more than 10 mg/day prednisolone or equivalent physiological doses of other corticosteroids);
- •long-term use of systemic hormones (dose equivalent to >10mg prednisone/day) or any other form of immunosuppressive therapy is required. Subjects using inhaled or topical corticosteroids can be enrolled;
- •Suffer from uncontrolled comorbidities, including but not limited to symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer or bleeding disorders.
- •With history of interstitial lung disease or non-infectious pneumonia. Subjects who have previously had drug-induced or radioactive non-infectious pneumonia but asymptomatic are allowed to enroll.
- •Patients have other conditions that are not suitable for enrollment according to the judgment of the investigator.
研究组 & 干预措施
Camrelizumab combined with CD30 CAR-T
Experimental
This study have only one arm that is Camrelizumab combined with CD30 CAR-T experimental arm.
干预措施: CD30 CAR-T (Biological)
Camrelizumab combined with CD30 CAR-T
Experimental
This study have only one arm that is Camrelizumab combined with CD30 CAR-T experimental arm.
干预措施: Camrelizumab (Drug)
结局指标
主要结局
overall response rate
时间窗: up to 3 months after CAR-T cell infusion
including complete remission (CR) or partial remission (PR)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: up to 90 days
To evaluate the safety of camrelizumab combined with CD30 CAR-T in the treatment of relapsed/refractory CD30+ lymphoma.
次要结局
- Time to Remission (TTR).(12 months)
- Duration of remission (DOR)(24 months)
- overall survival (OS)(24 months)
- Progression-free Survival (PFS)(24 months)
研究者
Jianfeng Zhou
Director of the Division of Hematology
Huazhong University of Science and Technology
研究点 (2)
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