EUCTR2020-000848-57-CZ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 and Richter’s Syndrome
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
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All Subjects
- •Subject must sign an ICF, prior to any screening procedures
- •Must be at least 18 years of age
- •ECOG performance status score of 0,1 or 2
- •Evidence of CD20 positivity at screening
- •Has acceptable laboratory parameters
- •Subject must have availability of fresh bone marrow material at screening
- •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 every cycle.
- •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.
- •Inclusion Criteria Specific to the R/R CLL Cohort
- •Must have active CLL disease that needs treatment
- •R/R CLL after receiving at least 2 prior lines of systemic antineoplastic 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
- •Must take prophylaxis for TLS
- •Inclusion Criteria Specific to the Richter’s Syndrome Cohort
- •Must have a clinical history of CLL/SLL with biopsy-proven transformation toward aggressive lymphoma (ie, DLBCL subtype).
- •Deemed as ineligible for chemoimmunotherapy at investigator’s discretion or refuse to receive intensive chemotherapy.
- •Must have measurable disease
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •All Subjects
- •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 agent, eg:
- •a. Small molecules such as BTK inhibitor, BCL2 inhibitor, or PI3K inhibitor within 5 half-lives prior to the first dose of epcoritamab; or
- •b. Anti-CD20 mAb or chemotherapy within 2 weeks prior to the first dose of epcoritamab;
- •c. Radio-conjugated or toxin conjugated antibody or CAR-T cell therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab
- •d. Subject received treatment with an investigational drug, 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 clinically significant cardiac disease
- •Subject received vaccination with live vaccines within 28 days prior to the first dose of epcoritamab
- •Subject has known central nervous system (CNS) involvement at screening.
- •Has had major surgery within 4 weeks prior to enrollment.
- •Known medical history or ongoing hepatitis C infection that has not been cured.
- •Known history of seropositivity for HIV infection. Note: HIV testing is required at screening only if required per local health authorities or institutional standards.
- •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.
- •Subject has uncontrolled intercurrent illness, such as ongoing or active infection requiring
- •intravenous antibiotics treatment at the time of enrollment or within the previous 2 weeks prior to the first dose of epcoritamab.
- •Exclusion Criteria Specific to the R/R CLL Cohort (numbering continues as per Protocol)
- •Any history of RS or evidence indicating a potential Richter’s transformation.
- •Subject is unable to tolerate uric acid reducing medications.
- •Exclusion Criteria Specific to the Richter’s Syndrome Cohort
- •Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin’s lymphoma,
- •prolymphocytic leukemia.
- •Subject received autologous HSCT within 3 months prior to the first dose of epcoritamab.
- •Subject received more than 1 prior line of therapy for RS.
研究者
相似试验
进行中（未招募）
1 期
Safety and Efficacy Study of Epcoritamab in Subjects with Relapsed/Refractory Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaEUCTR2020-000848-57-BEGenmab A/S26
招募中
不适用
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndromechronic lymphocytic leukemia10024324CLLNL-OMON54099Genmab10
进行中（未招募）
1 期
Safety and Efficacy Study of Epcoritamab in Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s SyndromeChronic Lymphocytic LeukemiaEUCTR2020-000848-57-NLGenmab A/S171
进行中（未招募）
1 期
Safety and Efficacy Study of Epcoritamab in Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome.MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864Chronic Lymphocytic LeukemiaEUCTR2020-000848-57-DKGenmab A/S171
进行中（未招募）
1 期
Safety and Efficacy Study of Epcoritamab in Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s SyndromeMedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864Chronic Lymphocytic LeukemiaEUCTR2020-000848-57-DEGenmab A/S171