NL-OMON51940招募中不适用
A Phase 1 and 2a open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and antitumor activity of LAVA-051 in patients with relapsed or refractory chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemia - LAVA-051
AVA Therapeutics BV0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- •1. Patient must be 18 years of age inclusive or above, at the time of signing
- •the informed consent.
- •2. Patients with documented diagnosis of CLL, MM, or AML who have failed to
- •respond to or who have relapsed after prior therapy and are not amenable to
- •standard treatments or for whom no standard treatments are available. Patients
- •may have undergone prior cell therapy.
- •2.1. CLL/ Small Lymphocytic Lymphoma (SLL) patients:
- •2.1.1. Proven disease by the presence of CD5+CD19+CD23+ clonal B cells in
- •blood, bone marrow and/or lymph nodes.
- •2.1.2. Patients should meet criteria for requiring therapy (the most recent
- •iwCLL guidelines (39)) and must have measurable disease (measurable lesion >
- •1.5 cm diameter in at least one dimension) and/or lymphocytosis.
- •2.1.3. Patients must have received at least 2 prior lines of therapy and must
- •have failed at least one line of targeted therapy (ibrutinib or venetoclax or
- •similar) and not be amenable to- or for whom no further standard treatment is
- •2.2. MM patients:
- •2.2.1. Documented diagnosis of MM and measurable disease (see Appendix 6,
- •Section 13.6.2; measurable disease is defined as serum monoclonal paraprotein
- •(M-protein) >= 5 g/L or urine M-protein >= 200 mg/24 hours or abnormal free light
- •chain (FLC) ratio with involved FLC > 100 mg/L or proven plasmacytoma by
- •2.2.2. Documented progression or refractory multiple myeloma as per the IMWG
- •uniform response criteria (see Appendix 6, Section 13.6.3) following >=3 prior
- •regimens that include at least one immunomodulatory drug, a proteasome
- •inhibitor, and an anti-CD38 monoclonal antibody in any order.
- •* If plasmacytoma is the only measurable parameter, the patient is not allowed
- •to be included in the trial, because of difficult response evaluation.
- •2.3. AML patients:
- •2.3.1. Patients with relapsed/refractory AML (defined using World Health
- •Organization [WHO] 2016 criteria, WHO classification definition of >= 20%
- •blasts) of any type with the exception of acute promyelocytic leukemia (APL;
- •AML M3). [Patients with a myelomonocytic or monocytic lineage (M4, M5) are most
- •likely to be positive for the CD1d expression].
- •2.3.2. Patients with relapsed/refractory AML (defined as hematologic
- •relaps,molecular relaps, or primary refractory disease as per ELN 2017
- •quidelines)
- •3. Males or non-pregnant, non-breastfeeding females who are:
- •a. Surgically sterile (hysterectomy, bilateral oophorectomy or bilateral
- •salpingectomy, vasectomy).
- •b. Female of childbearing potential with a negative pregnancy test prior to
- •first dosing and compliant with a highly effective contraceptive regimen (i.e.,
- •pregnancy rate of <1% per year: oral contraceptives, intrauterine device (IUD),
- •intrauterine hormone-releasing systems; refer to Appendix 4. Section 13.4 for
- •more details) from signing of the informed consent form (ICF) through 90 days
- •after the last IMP administration. Abstinence is not considered an adequate
- •contraceptive regimen.
- •c. Female, postmenopausal defined as continuous amenorrhea for at least 12
- •consecutive months without an alternative medical cause and a serum
- •follicle-stimulating hormone (FSH) measurement of > 40 IU/L).
- •d. Male, compliant with an effective contraceptive regimen (i.e., use of male
- •condom with female partner and assuring use of an additional highly effective
排除标准
- •1. Prior allogeneic bone marrow transplant if the patient still has active
- •acute or chronic graft versus host disease requiring >10 mg prednisone or
- •equivalent corticosteroids.
- •2. Concomitant malignancies except carcinoma in situ, basal or squamous cell
- •skin carcinoma. Patients who had no evidence of disease from another primary
- •cancer for 2 or more years are allowed to participate in the trial. Localized
- •non-metastatic prostate cancer, not requiring systemic treatment, and for which
- •no local treatment is planned, is allowed.
- •3. Uncontrolled or severe intercurrent medical condition.
- •4. Known uncontrolled central nervous system involvement.
- •5. Patient has any active-, uncontrolled-, or suspected infection.
- •6. A significant history of renal, neurologic, psychiatric, pulmonary,
- •endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that
- •in the opinion of the investigator would adversely affect patients'
- •participating in this trial.
- •7. Unstable cardiovascular function defined as: (a) symptomatic ischemia, or
- •(b) uncontrolled clinically significant conduction abnormalities (i.e.,
- •ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree
- •atrioventricular block or asymptomatic left anterior fascicular block/right
- •bundle branch block will not be excluded), or (c) congestive heart failure New
- •York Heart Association Class >= 3, or (d) myocardial infarction within 3 months
- •or (e) QTc>480 msec using Fredericia's QT formula.
- •8. Previous treatment with radiotherapy, immunotherapy, investigational product
- •or chemotherapy in the 2 weeks prior to initial IMP administration.
- •9. Previous treatment with an aminobisphosphonate IV (e.g., ibandronate,
- •pamidronate, zoledronate etc) within 4 weeks prior to initial IMP.
- •10. Previous treatment of any systemic immunosuppressant within 2 weeks prior
- •to initial IMP administration, with the exception of systemic corticosteroid
- •use up to oral dose of 10 mg prednisolone daily (or equivalent for other
- •11. Previous treatment with live or live attenuated vaccines within 2 weeks
- •prior to initial IMP administration. Other (new) types of vaccines need to be
- •evaluated as to their mode of action.
- •12.Previous autologous haematopoietic stem cell transplantation (HSCT) or
- •treatment with Chimeric Antigen Receptor (CAR) T-cell therapy within 6 months
- •prior to initial IMP administration.
- •13. Known non-CLL/MM/AML related pre-existing clinically relevant
- •immunodeficiency disorders.
- •14. Patients with Richter*s transformation are excluded.
- •15. Positive serological testing for Human Immunodeficiency Virus (HIV)
- •antibody, hepatitis B surface antigen [HBsAg] and hepatitis B core antibody
- •(anti-HBc) negative, and hepatitis C virus antibody. Patients who are positive
- •for anti-HBc or hepatitis C antibody may be included if they have a negative
- •PCR within 6 weeks prior to initial IMP administration. Those who are PCR
- •positive will be excluded.
- •16. Known allergies, hypersensitivity, or intolerance to the excipients of the
- •17. Major surgery within 4 weeks of initial IMP administration or planned
- •surgery during the time the patient is expected to participate in the trial.
- •18. Known ongoing drug and alcohol abuse in the opinion of the investigator.
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