NL-OMON54003招募中不适用
A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton*s Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies - NX-5948-301
urix Therapeutics, Inc0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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
- •- Patients must be >= 18 years of age, and mentally competent
- •Patients in Phase 1a (Dose Escalation) must have 1 of the following
- •histologically confirmed R/R B-cell malignancies: R/R CLL, SLL, DLBCL of the
- •following subgroups: DLBCL, not otherwise specified (NOS), geminal center
- •B-cell type, activated B-cell type (includes transformed indolent lymphoma
- •[eg, grade 3b/transformed FL] and Richter-transformed DLBCL, high-grade B-cell
- •lymphoma (HGBL) with MYC and BCL-2 and/or BCL-6 rearrangements, high-grade
- •B-cell lymphomas NOS), (note: other subgroups of DLBCL or LBCL from the 2016
- •WHO classification of lymphoid malignancies are excluded), FL (grade 1-3a;
- •eligibility for systemic treatment as determined by the Groupe d*Etude des
- •Lymphomes Folliculaires [GELF] criteria), MCL, MZL (eligible subtypes include
- •EMZL, MALT, NMZL and SMZL), WM, PCNSL.
- •- Patients in Phase 1a must meet the following:
- •a. For non-PCNSL indications, received at least 2 prior lines of therapy and
- •have no other therapies known to provide clinical benefit.
- •b. For PCNSL, received at least 1 prior line of therapy.
- •Patients in Phase 1b (Safety Expansion) must have 1 of the following
- •histologically documented R/R B-cell malignancies, must meet criteria for
- •systemic treatment, and must have received the following prior therapies based
- •on indication:
- •CLL/SLL arm:
- •CLL or SLL with prior exposure to both a BTKi and BCL-2 inhibitor, unless
- •previously deemed ineligible for those therapies.
- •MCL with prior exposure to a BTKi and an anti-CD20 monoclonal antibody
- •(mAb)-based chemo-immunotherapy regimen.
- •MZL (EMZL, MALT, NMZL, SMZL) with prior exposure to an anti-CD20 mAb-based
- •chemo-immunotherapy regimen and an additional line of therapy.
- •WM with prior exposure to a BTKi and an additional line of therapy.
- •DLBCL of the following subgroups with prior exposure to an anthracycline
- •(unless previously deemed ineligible to receive), an anti-CD20 mAb based
- •chemo-immunotherapy regimen, and an additional line of therapy:
- •o NOS, germinal center B-cell type, activated B-cell type (includes transformed
- •indolent lymphoma [eg, grade 3b/transformed FL] and Richter-transformed DLBCL.
- •o HGBL with MYC and BCL-2 and/or BCL- 6 rearrangements, and HGBL NOS
- •(note: other subgroups of DLBCL or LBCL from the WHO classification of lymphoid
- •malignancies
- •FL (grade 1-3a; eligibility for systemic treatment as determined by the GELF
- •criteria) with prior exposure to an anti-CD20 mAb-based chemo-immunotherapy
- •regimen and an additional line of therapy.
- •PCNSL/SCNSL arm:
- •PCNSL patients who have progressed or had no response to at least 1 prior
- •line of therapy.
- •SCNSL patients meeting criteria for non-CLL/SLL arms above with secondary CNS
- •involvement of lymphoma.
排除标准
- •- Known or suspected prolymphocytic leukemia or Richter*s transformation to
- •Hodgkin*s lymphoma at any time preceding enrollment.
- •- Prior treatment for the indication under study for anti-cancer intent that
- •a. Radiotherapy within 2 weeks of planned start of study drug (excluding
- •limited plaliatiev radiation).
- •b. Prior systemic chemotherapy within 2 weeks of planned start of study drug.
- •Note: Use of intrathecal chemotherapy is allowed per institutional guidelines.
- •c. Prior mAb therapy within 4 weeks of planned start of study drug.
- •d. Prior small molecule therapy within 5 half-lives or 2 weeks (whichever is
- •shorter) of planned start of study drug.
- •e. Autologous or allogeneic stem cell transplant within 100 days prior to
- •planned start of study drug.
- •f. Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to
- •start of study drug (within 60 days prior to start of study drug for Phase
- •g. Use of systemic corticosteroids outside of dosing limits described below and
- •within 14 days prior to initiation of study treatment excepting those used as
- •prophylaxis for radio diagnostic contrast. Patients with central nervous system
- •lymphoma (CNSL, including both primary and secondary CNSL): no greater than 40
- •mg/day prednisone, or equivalent; CNSL patients using greater than 20 mg/day
- •prednisone, or equivalent must be clinically stable at that dose for 14 days.
- •All other diagnoses: no greater than 20 mg/day prednisone or equivalent.
- •h. Use of systemic immunosuppressive drugs other than systemic corticosteroids
- •for any medical condition within 60 days, prior to first dose of study drug.
- •i. Previously treated with a BTK degrader.
- •- Active, uncontrolled autoimmune hemolytic anemia or autoimmune
- •thrombocytopenia.
- •- Patient has any of the following:
- •a. Myocardial infarction, unstable angina, unstable symptomatic ischemic heart
- •disease, or placement of a coronary arterial stent within 6 months of planned
- •start of study drug.
- •b. Uncontrolled atrial fibrillation or other clinically significant
- •arrhythmias, conduction abnormalities, or New York Heart Association (NYHA)
- •class III or IV heart failure within 6 months of planned start of study drug.
- •c. Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or
- •symptomatic cerebrovascular events), stroke, or intracranial hemorrhage within
- •6 months of planned start of study drug.
- •d. Any other significant cardiac condition (eg, pericardial effusion,
- •restrictive cardiomyopathy, severe untreated valvular stenosis, severe
- •congenital heart disease, or persistent uncontrolled hypertension defined as
- •systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg
- •despite optimal medical management) within 6 months of planned start of study
- •- Bleeding diathesis, or other known risk for acute blood loss.
- •- History of Grade >= 2 hemorrhage within 28 days of planned start of study
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