NL-OMON54099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 Syndrome - GCT3013-03
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Genmab
- 入组人数
- 10
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
- 年龄范围
- 18 至 99（—）
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 in a sample representative of the disease (eg,
- •tumor biopsy/peripheral blood/bone arrow) at Screening
- •Has acceptable laboratory parameters
- •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 (betahCG)
- •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
- •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
- •Criteria Specific to Subjects With R/R CLL- Dose Escalation Monotherapy (All
- •Cohorts) and Expansion Monotherapy (Arm 1)
- •Must have active CLL/SLL disease that needs treatment.
- •R/R CLL after receiving at least 2 prior lines of therapy.
- •Diagnosis of CLL/SLL that meets published diagnostic criteria
- •Must take prophylaxis for TLS
- •Inclusion Criteria Specific to Subjects With Richter's Syndrome - Expansion
- •Monotherapy Arm 2A
- •Must have measurable disease as determined by FDG- PET CT and a CT scan (or
- •Must provide a mandatory FFPE tumor tissue sample;
- •Inclusion Criteria Specific to Subjects With Richter's Syndrome - Lenalidomide
- •Combination Therapy Expansion Arm 2B
- •Have tumor biopsy-proven CD20+ DLBCL and a clinical history of CLL/SLL.
- •Deemed as ineligible for chemoimmunotherapy
- •Eligible for treatment with lenalidomide.
- •Must have measurable disease as determined by FDG- PET CT and a CT scan (or
- •Must provide a mandatory FFPE tumor tissue sample;
- •Females of childbearing potential must use 2 forms of contraception
- •A woman of childbearing potential must have a negative serum (betahCG)
- •pregnancy test
- •Males must always use a latex or synthetic condom during any sexual contact
- •with females of reproductive potential while taking lenalidomide
- •Inclusion Criteria Specific to Subjects With Richter's Syndrome - R-CHOP
- •Combination Therapy Expansion Arm 2C
- •Have tumor biopsy-proven CD20+ DLBCL and have a clinical history of CLL/SLL.
- •Eligible to receive R-CHOP per investigator determination.
- •Must have measurable disease as determined by FDG- PET CT and a CT scan (or
- •Must provide a mandatory FFPE tumor tissue sample;
- •Inclusion Criteria Specific to Subjects with R/R CLL - Venetoclax Combination
- •Therapy Dose Escalation Cohorts and Expansion Arm 3
- •Must have active CLL/SLL disease that needs treatment
- •At least 1 of the following disease-related (constitutional) symptoms:
- •Unintentional weight loss >= 10% within the previous 6 months
- 另有 1 项未显示
排除标准
- •All Subjects • Subject received prior treatment with a CD3×CD20 bsAb. • Subject
- •received any prior allogeneic HSCT or solid organ transplantation • Subject
- •received treatment with an anticancer agent, as follows: - 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 • Uncontrolled autoimmune hemolytic anemia or immune
- •thrombocytopenia (requiring >20 mg of prednisolone daily) or other concurrent
- •uncontrolled medical conditions. • Unstable or uncontrolled disease/condition
- •related to or affecting cardiac function, eg, unstable angina, congestive heart
- •failure grade III or IV as classified by the New York Heart Association (see
- •Appendix 3), uncontrolled clinically significant cardiac arrhythmia (CTCAE v5.0
- •grade 2 or higher), or clinically significant ECG abnormalities • Myocardial
- •infarction, intracranial bleed, or stroke within the past 6 months • Subject
- •age >=75 and 2 or more active grade >=2 cardiovascular conditions. • Subject has
- •toxicities from previous anticancer therapies that have not resolved to
- •baseline levels or to grade 1 or less except for alopecia and peripheral
- •neuropathy • Subject has history or presence of clinically relevant disorder
- •affecting the CNS • ICE score of less than 8 at study entry • Subject has known
- •past or current malignancy other than inclusion diagnosis, except for: a.
- •Cervical carcinoma of Stage 1B or less b. Non-invasive basal cell or squamous
- •cell skin carcinoma c. Non-invasive, superficial bladder cancer d. Prostate
- •cancer with a current PSA level <0.1 ng/mL e. Any curable cancer with a CR of
- •>2 years duration • Subject has suspected allergies, hypersensitivity, or
- •intolerance to epcoritamab or another anti-CD20 mAb or its excipients (refer to
- •the IB for more information). • Active HBV (DNA PCR-positive). Subjects with
- •evidence of prior HBV but who are PCR-negative are permitted in the trial but
- •should receive prophylactic antiviral therapy. • Active hepatitis C (RNA
- •PCR-positive infection). Subjects who received treatment for HCV that was
- •intended to eradicate the virus may participate if hepatitis C RNA levels are
- •undetectable • Subject is a woman who is pregnant or breastfeeding, 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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