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: 2021年2月2日最近更新: 2024年5月21日

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

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 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 < 100x109/L (100,000/µL) in the peripheral blood and presence of measurable lymphadenopathy and/or organomegaly.
•-Has 1 of the following B-cell NHL subtypes for the 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 < 100x109/L (100,000/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).
•- A woman of reproductive potential must agree to use adequate contraception during the trial and for 12 months after the last GEN3009 administration. Adequate contraception is defined as highly effective methods of contraception (refer to Appendix 12 for more information). In countries where 2 highly effective methods of contraception are required, both methods will be required for inclusion and must have a negative serum beta-human chorionic gonadotropin (beta-hCG) 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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