EUCTR2020-000848-57-BE进行中（未招募）1 期
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genmab A/S
- 入组人数
- 26
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
- •Subject must sign an ICF, prior to any screening procedures
- •Must be at least 18 years of age
- •Must have active CLL disease that needs treatment per iwCLL2018 (refer to Section 5.1 for details).
- •R/R CLL after receiving at least 2 prior lines of systemic antineoplastic therapy, including treatment with (or intolerance of) a BTK inhibitor (eg, ibrutinib); Relapse is defined as evidence of disease progression in a subject who has previously achieved a complete response (CR) or partial response (PR) for =6 months. Refractory disease is defined as treatment failure (not achieving a CR or PR) or as progression within 6 months from the last dose of therapy.
- •Has Measurable Disease with at least one of the following criteria:
- •a. =5 × 109/L (5,000/µL) B lymphocytes in peripheral blood
- •b. Presence of measurable lymphadenopathy and/or organomegaly
- •ECOG performance status score of 0 or 1
- •Screening flow cytometry evidence of CD20 positivity
- •Has acceptable laboratory parameters
- •Subject must have availability of fresh bone marrow material at screening
- •Must take prophylaxis for TLS
- •A woman with reproductive potential must agree to use adequate contraception during the trial, and for 12 months after the last administration of epcoritamab.
- •A woman of childbearing potential must have a negative serum (beta-hCG) pregnancy test at screening and a negative serum or urine pregnancy test before treatment administration on Day 1 of Cycle 1
- •A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial, until 12 months after last treatment.
- •A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •Transformation of CLL to aggressive non-Hodgkin lymphoma
- •Subject received prior treatment with a CD3 × CD20 bispecific antibody.
- •Subject received any prior allogeneic HSCT or solid organ transplantation
- •Subject received treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-conjugated antibody or CAR T-cell therapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of epcoritamab
- •Subject received chemotherapy or radiation therapy within 2 weeks of the first dose of epcoritamab
- •Subject received treatment with an investigational drug or an invasive investigational medical device within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab.
- •Subject has autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
- •Subject has uncontrolled intercurrent illness
- •Has a baseline QT interval at screening as corrected by Fridericia’s formula (QTcF) >480 msec
- •Subject received vaccination with live vaccines within 28 days prior to the first dose of epcoritamab
- •Subject has toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy
- •Subject has known central nervous system involvement at screening.
- •Subject has suspected allergies, hypersensitivity, or intolerance to epcoritamab or its excipients (refer to the IB for more information).
- •Subject is unable to tolerate uric acid reducing medications
- •Has known history/positive serology for hepatitis B
- •Known medical history or ongoing hepatitis C infection that has not been cured.
- •Subject tests positive for HIV at screening.
- •Subject is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab.
- •Subject is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of epcoritamab.
研究者
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