EUCTR2020-004583-26-FR招募中1 期
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
AVA Therapeutics B.V.0 个研究点目标入组 102 人开始时间: 2022年8月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
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
- •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 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 available
- •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 biopsy*)
- •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 relapse, molecular relapse, or primary refractory disease as per ELN 2017 guidelines).
- •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 contraceptive method with a failure rate of <1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant following from signing of the ICF through 90 days after the last IMP administration; refer to A
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' participation 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 correction 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 steroids).
- •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 IMP.
- •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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