Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma – A First-in-Human, Open-label, Phase I/IIa Dose Escalation Trial with Dose Expansion Cohorts

Genmab Holding B.V.0 个研究点目标入组 120 人开始时间: 2020年1月23日最近更新: 2023年10月16日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Genmab Holding B.V.
入组人数: 120

研究概览入排标准研究者记录与标识符相似试验

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

•Each potential subject must fulfill all of the following criteria to be enrolled in the trial.
•- Be at least 18 years of age.
•- Must sign an informed consent form (ICF) prior to any screening procedures.
•- Has histologically or cytologically confirmed relapsed and/or refractory B-cell NHL with no available standard therapy or is not a candidate for available standard therapy.
•- Has 1 of the following B-cell NHL subtypes for the Dose Escalation:
•o DLBCL, de novo or histologically transformed
•o FL, with advanced symptomatic disease and with a need for treatment
•o MCL, without leukemic manifestation
•o MZL, either nodal, extranodal or mucosa associated, with a need for treatment initiation based on symptoms and/or disease burden
•o SLL, with a need for treatment based on symptoms and/or disease burden
•o CLL, with B-cell count < 20x109/L (20,000/µL) in the peripheral blood and presence of measurable lymphadenopathy and/or organomegaly.
•-Has 1 of the following B-cell NHL subtypes for the Dose Expansion:
•o DLBCL, de novo or histologically transformed
•o FL, with advanced symptomatic disease and with a need for treatment initiation
•o CLL, with B-cell count < 20x109/L (20,000/µL) in the peripheral blood and presence of measurable lymphadenopathy and/or organomegaly.
•- Has measurable disease for B-cell NHL, or has active disease for CLL (refer to Protocol Section 5.1 for details).
•- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
•- Has acceptable laboratory parameters (refer to protocol for details).
•- Before the first dose of GEN3009, during the trial, and for 12 months after the last dose of GEN3009, a woman must be either not of childbearing potential or of childbearing potential and practicing a highly effective method of birth control, and must have a negative serum beta-human chorionic gonadotropin (beta-hCG) and urine pregnancy test at screening.
•- 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 72
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 48

排除标准

•Any potential subject who meets any of the following criteria will be excluded from participating in the trial.
•- Prior treatment with a CD37-targeting agent.
•- Prior allogeneic hematopoietic stem cell transplantation (HSCT).
•- Autologous HSCT within 3 months before the first dose of GEN3009.
•- Treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-conjugated antibody or chimeric antigen receptor-T (CAR-T) cell therapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of GEN3009.
•- Chemotherapy or radiation therapy within 2 weeks of the first dose of GEN3009.
•- 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 GEN3009. Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
•- Received a cumulative dose of corticosteroids more than the equivalent of 250 mg of prednisone within the 2–week period before the first dose of GEN3009.
•- Has uncontrolled intercurrent illness (refer to Protocol Section 5.2 for details).
•- Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
•- Primary central nervous system (CNS) lymphoma or known CNS involvement at screening.
•- Has known past or current malignancy other than inclusion diagnosis (refer to Section 5.2 for details).
•- Has had major surgery within 3 weeks before screening or will not have fully recovered from surgery, or has major surgery planned during the time the subject is expected to participate in the trial (or within 4 weeks after the last dose of GEN3009).
•- Has known history/positive serology for hepatitis B.
•- Known medical history or ongoing hepatitis C infection that has not been cured.
•- HIV tested positive at screening.
•- 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 GEN3009.
•- Is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of GEN3009.

研究者

发起方

Genmab Holding B.V.

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