EUCTR2020-001985-12-FR进行中（未招募）1 期
A Phase II Trial Evaluating Glofitamab, a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas after CAR T-cells therapy - BiCAR Therapy
YSARC0 个研究点目标入组 78 人开始时间: 2020年12月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients meeting all of the following criteria will be considered for enrollment into the study:
- •1.Patients who received CAR T-cells therapy for R/R DLBCL (cohort 1) or R/R PMBL, mantle cell lymphoma, t-iNHL or iNHL (cohort 2), at least 1 month ago
- •2.Patients who are not at least in partial metabolic response from 1 month after CAR T-cells infusion (i.e no metabolic response or first metabolic progressive disease or first relapse from 1 month after CAR T-cells infusion)
- •3.First metabolic progression, first relapse or no metabolic response after CAR T-cells infusion must be confirmed by PET-CT central review for enrollment
- •4.DLBCL with demonstrated lymphoma cells-expressing CD20 at relapse post CAR T-cells as demonstrated by biopsy before inclusion (cohort 1 only)
- •5.Aged 18 years or more with no upper age limit
- •6.ECOG performance status 0 or 1
- •7.Bi-dimensionally measurable disease defined by at least one single node or tumor lesion > 1.5 cm assessed by CT scan, or PET-CT with at least one hypermetabolic lesion
- •8.No persistant CAR-T neurotoxicity symptoms or previous experience during CAR T-cells therapy of neurotoxicity grade > 3
- •9.Adverse events from prior anti-cancer therapy must have resolved to Grade = 1 (hematological toxicities excepted).
- •10.Adequate liver function: Total bilirubin = 1.5 x ULN; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 3 x ULN.
- •Note: Patients with documented history of Gilbert’s Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible)
- •11.Adequate hematological function: Neutrophil count of = 1.0 G/L; Platelet count of = 50 G/L (and platelet transfusion free within 14 days prior to administration of obinutuzumab); Hemoglobin (Hb) = 8.0 g/dL (transfusion free within 21 days prior to administration of obinutuzumab).
- •Note: patients who do not meet the above hematologic criteria, due to extensive tumor involvement in the marrow may be enrolled into the trial after the demonstration of involvement and consultation with the LYSARC. Please consult the LYSARC on the need for transfusion support within 21 days of obinutuzumab.
- •12.Adequate renal function: creatinine clearance (CrCl) calculated by MDRD/Cockroft-Gault formula of = 30 mL/min
- •13.Negative serum or urinary pregnancy test within 7 days prior to study treatment in women of childbearing potential.
- •14.Negative serologic or PCR test results for acute or chronic HBV infection. Note: Patients whose HBV infection status cannot be determined by serologic test results must be negative for HBV by PCR to be eligible for study participation.
- •15.Negative test results for HCV and HIV.
- •Note: Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation.
- •16.Patients must agree to either remain completely abstinent or to use two effective contraceptive methods until :
- •- If the patient is a male: at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab
- •Men must refrain from donating sperm during this same period
- •- If patient is a female of childbearing potential: until at least 18 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab
- •17.Patient must be willing and able to comply with protocol-mandated hospitalization upon administration of the first dose of glofitamab. Patient must also be willing to comply with all study-related procedures.
- •18.Signed w
排除标准
- •Patients meeting any of the following criteria will not be included in the study:
- •1.Previously known CD20 negative status, excepted if a new biopsy for cohort 1 or biopsy or cytometry analysis for cohort 2 proving a CD20 positive status is available before enrollment
- •2.Patients with CLL, Richter and Burkitt lymphoma.
- •3.Patients relapsing or progressing within 1 months (30 days) after CAR T-cells therapy
- •4.History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:
- •- Grade = 3 adverse events with the exception of Grade 3 endocrinopathy managed with replacement therapy
- •- Grade 1-2 adverse events that did not resolve to baseline after treatment discontinuation
- •5.Current or past history of detectable cerebrospinal fluid lymphoma cells, or with a history of CNS lymphoma localization or primary CNS lymphoma.
- •6.Current or past history of cerebral disorders
- •7.Any serious psychiatric illness that would prevent the subject from signing the informed consent form
- •8.Patients with history of macrophage activation syndrome (MAS)/hemophagocytic lymphohistiocytosis (HLH)
- •9.Patients with known acute infection or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, EBV, cytomegalovirus (CMV), hepatitis B, hepatitis C, and HIV), fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) in 2 week prior to enrollment.
- •10.LVEF < 40% as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan or significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina)
- •11.Any serious active disease or co-morbid medical condition
- •12.Clinically significant history of liver disease or cirrhosis
- •13.Prior history of malignancies other than lymphoma unless the subject has been free of the disease for = 3 years. Exceptions will be allowed for patients with non-melanoma skin tumors (basal cell or squamous cell carcinoma of the skin) or any surgically removed stage 0 (in situ) carcinoma
- •14.Prior solid organ transplantation.
- •15.Prior allogeneic SCT
- •16.Autologous SCT within 100 days prior to obinutuzumab infusion.
- •17.Current uncontrolled autoimmune disease
- •Note: History of automimmune disease currently controlled and stable is acceptable for such therapy. See detailed description in paragraphe 8.2
- •18.Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.
- •19.Major surgery or significant traumatic injury < 28 days prior to the obinutuzumab infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment.
- •20.Administration of a live, attenuated vaccine within 4 weeks before obinutuzumab infusion
- •21.Treatment between infusion of the CAR T-cells and pre-phase (i.e. obinutuzumab infusion on C1/D-3): with standard radiotherapy, systemic immunotherapeutic agents, any chemotherapeutic agent, any systemic immunosuppressive medications or treatment with any other investigational anti-cancer agent (defined as treatment for
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