A Phase 1/2, Multicenter, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients with CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies

Immunogen Inc.0 个研究点目标入组 179 人开始时间: 2024年6月25日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 179

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 clinical trial of medicinal product

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Disease Characteristics: a. Confirmation of CD123 positivity by flow cytometry or immunohistochemistry. Patients who received prior CD123-targeting agents will be allowed as long as the blasts still have detectable CD123 expression b. Dose Escalation – Relapsed or refractory AML (excluding acute promyelocytic leukemia) or BPDCN, based on World Health Organization Classification. c. Dose Expansion - Cohort 1 - Patients with relapsed or refractory BPDCN - Cohort 2 – Patients will have relapsed AML (closed to enrollment). - Cohort 3 – Patients will have relapsed or refractory ALL (including any subtypes: B-cell, T-cell, Ph+ and Ph-) (closed to enrollment). - Cohort 4 – Patients will have relapsed or refractory other hematologic malignancies not included in the cohorts above (e.g., high-risk/very high-risk MDS, MPN, CMML, BP-CML). Other CD123+ malignancies may be considered upon discussion with the Sponsor. Note: BP-CML is defined as = 30% blasts in blood, marrow, or both and the demonstration of extramedullary infiltrates of leukemic cells. - Cohort 5 – Patients will have relapsed or refractory (to nonintense therapies) AML (closed to enrollment). - Cohort 6 – Patients with frontline de novo BPDCN at screening who have not received prior systemic therapy and patients with frontline BPDCN who have a PCHM and have not received prior systemic therapy. Note: Patients in Cohort 6 may have received local therapy (radiotherapy, surgical excision, photodynamic therapy). Eligible patients must have a recurrence or progression in the field of local therapy OR disease outside the field of local therapy. Patients identified as having concomitant malignancy while on trial will continue to be identified as de novo BPDCN patients., Patients with a prior autologous or allogeneic bone marrow transplant are eligible for Cohorts 1 to 5. Patients with an allogeneic transplant must meet the following conditions: the transplant must have been performed more than 120 days before the date of dosing on this study, the patient must not have active = Grade 2 acute graft versus host disease (GvHD), or extensive chronic GvHD of any severity, and must be off all immunosuppression for at least 2 weeks before first dose of IMGN632., Voluntary written informed consent before performance of any study-related procedure not part of normal medical care., Women of childbearing potential WCBP patients/partners, defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (ie, who has had menses any time in the preceding 12 consecutive months) must agree to use acceptable contraceptive methods while on study drug and for at least 7 months after the last dose of study drug., WCBP must have a negative pregnancy test before the first dose of study drug., Male patients/partners who are able to father children must agree to use an effective method of contraception (eg, condoms), even if they have had a successful vasectomy, throughout the study and for at least 4 months after the last dose of IMGN632., Patients with prior malignancy are eligible. Patient with a PCHM are eligible as long as no current therapy is required for the second malignancy (eg, MDS, CMML). Patients with a nonhematologic prior malignancy must be in remission from the prior malignancy and have completed all chemotherapy and radiotherapy for prior malignancy at least 6 months prior to enrollment and all treatm

排除标准

•Patients who, in the judgment of their treating physician, have appropriate standard of care therapies will be excluded from Cohorts 1 through 5., Serious or poorly controlled medical conditions that could be exacerbated by treatment or that would seriously compromise safety assessment or compliance with the protocol, in the judgment of the Investigator., Patients who are pregnant or breast-feeding., Patients who have a history of allergy to IMGN632 or any of its excipients., Patients who received a live vaccine four weeks or fewer prior to enrollment, Frontline BPDCN patients with CNS disease will be excluded. A lumbar puncture must be performed during the 28-day Screening period, before drug administration. Relapsed or refractory BPDCN patients with a known history of CNS disease must have been treated locally, have at least 1 lumbar puncture with no evidence of CNS disease, and must be clinically stable before first dose. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS disease is encouraged (see Section 5.2.4.1)., Patients with a history of veno-occlusive disease of the liver., Patients with a history of Grade 4 capillary leak syndrome, or noncardiac Grade 4 edema are ineligible, e.g., related to tagraxofusperzs or other etiology., Corrected QT interval (QT interval corrected using Fridericia's) > 480 msec., Myocardial infarction within 6 months before enrollment or has New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities before study entry., Interval from prior cancer therapy: a. For frontline BPDCN patients with prior local therapy (eg, radiotherapy), patients must not have received treatment within 14 days before drug administration on this study. b. Relapsed or refractory BPDCN patients must not have received any anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agents within 14 days prior to drug administration on this study. Patients must have recovered to baseline from all acute toxicity from this prior therapy. Note: Patients who have received a checkpoint inhibitor must not have received that therapy within 28 days before drug administration on this study., Clinically relevant active infection including known active hepatitis B or C, human immunodeficiency virus infection, or cytomegalovirus or any other known concurrent infectious disease that, in the judgment of the Investigator, would make a patient inappropriate for enrollment into this study (testing not required)., Patients who have undergone a major surgery within 4 weeks (or longer if not fully recovered) before study enrollment.

研究者

发起方

Immunogen Inc.

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