EUCTR2021-002339-44-DK进行中（未招募）1 期
A Phase 1/2 Open-Label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of IGM-2323 in Subjects with Relapsed/Refractory Non-Hodgkin Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
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
- •Below is a summary of the principal inclusion criteria. Please refer to protocol for all inclusion criteria.
- •>/= 18 years of age: ECOG PS 0 or 1
- •Relapsed or Refractory Follicular Lymphoma (FL), and Diffuse Large B-cell Lymphoma (DLBCL),
- •Also Mantle cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) in dose escalation
- •Relapsed or refractory to at least 2 prior systemic treatment regimens (must include anti-CD20 based chemoimmunotherapy regimen).
- •FL and MZL may be enrolled with at least 2 prior systemic regimens which must have included an anti-CD20 therapy (and without need for a prior chemotherapy regimen).
- •For subjects in Cohort G3, prior CD20 x CD3 bispecific T-cell engagers may be enrolled, provided that they did not have Grade 2 or higher CRS on their previous treatment and completed at least 2 cycles of their prior treatment.
- •At least one bi-dimensionally measurable lesion (=1.5cm in it’s longest dimension by computerized tomography (CT scan)
- •Good organ and bone marrow function, evidenced by laboratory assessments
- •Not eligible for autologous stem cell transplant (DLBCL subjects), due to chemo resistant disease, medically unfit (organ function), or unwilling.
- •All patients must have at least 1 tumor site that can be biopsied and be willing to have pre-treatment and on-treatment biopsies.
- •- Subjects for whom biopsies are medically contraindicated or for whom the treating physician does not feel that it is in the best interest of the subject may still enter the study after a discussion with the study Sponsor.
- •- Site of biopsy should be distinct from target lesions used for efficacy assessment
- •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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •Below is a summary of the principal exclusion criteria. Please refer to protocol for all exclusion criteria.
- •Known Double/Triple Hit Lymphoma, CLL, or Richters transformation
- •Known lack of cancer cell CD20 expression by IHC, flow cytometry, gene expression or another assay
- •Prior allogeneic transplant or organ transplant
- •ASCT within 100 days prior to the first IGM-2323 administration.
- •Prior treatment with CD3 engaging bispecific antibodies (except for Phase I/Stage IV Group 3)
- •Lack of response to prior treatment with CAR-T therapy, subjects with less than 3 months from prior CAR-T therapy to first dose of IGM-2323, and prior CAR-T therapy only allowed with Medical Monitor approval.
- •Concurrent serious co-morbidities that could limit patients’ full participation and compliance
- •Prior use of any mAB, systemic immunotherapeutic agent or small molecule target therapy within 3 weeks of first dose of IGM-2323
- •Treatment with radiotherapy within 1 week prior to the first IGM-2323 administration.
- •- If subjects have received radiotherapy within 4 weeks prior to the first IGM-2323 administration, subjects must have at least 1 measurable lesion outside of the radiation field.
- •- Subjects who have only 1 measurable lesion that was previously irradiated but subsequently progressed are eligible.
- •Current central nervous system (CNS) lymphoma (history of CNS lymphoma allowed if in remission, no evidence of disease by head magnetic resonance imaging [MRI], and not requiring steroid therapy).
- •Known active and clinically significant infection requiring treatment with IV antibiotics or hospitalization within 4 weeks of first IGM-2323 dose
- •Acute or chronic HCV infection, known history of HIV seropositivity
- •Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide and the anti-tumor necrosis factor agents) with the exception of corticosteroid treatment = 10 mg/day prednisone or equivalent within 2 weeks prior to first dose of IGM-2323.
- •History of unstable angina, MI, cardiac angioplasty or stenting, or pulmonary embolism within 6 months of enrollment
- •Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment, or indicating subject would unlikely have potential benefit
研究者
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