NL-OMON44047已完成不适用
Open label, multicenter phase I study of IPH4102, a humanized anti-KIR3DL2 monoclonal antibody, in patients with relapsed/refractory cutaneous T-cell lymphomas (CTCL) - IPH4102CTC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
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
- •Note: In the dose escalation portion, all subtypes of relapsed/refractory CTCL will be
- •allowed, in the cohort expansion portion inclusion of specific CTCL subtypes is planned
- •according to findings of the dose escalation portion (e.g. tMF and SS).
- •1) Patients with relapsed/refractory, biopsy-proven primary cutaneous T-cell lymphoma who have
- •received at least two previous standard systemic therapies and, if MF/SS, is stage IBIVB
- •at study entry. Total skin electron beam irradiation is not regarded as systemic
- •2) Centrally assessed KIR3DL2 expression on tumor cells. A blood sample and skin
- •biopsies will be obtained within 4 weeks of beginning study medication, for
- •assessment of KIR3DL2 by flow cytometry or immunohistochemistry (IHC). KIR3DL2
- •expression on *5% malignant cells in skin or on *5% malignant cells in blood
- •(Immunophenotype: CD3+CD4+CD8-) is regarded as KIR3DL2 positive. If a patient has
- •different lesion morphology (patch, plaque, tumor), a biopsy will be obtained from each
- •morphologic lesion and KIR3DL2-positivity in at least one lesion will be sufficient for
- •enrolment of a patient.
- •3) Patients must have the following minimum wash-out from previous treatments:
- •- *12 weeks for total skin electron beam irradiation,
- •- *4 weeks for monoclonal antibodies (* 8 weeks for alemtuzumab),
- •- *3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy,
- •treatment with other anti-neoplastic investigational agents,
- •- *3 weeks for systemic retinoids, interferons, vorinostat, romidepsin, fusion proteins,
- •- *3 weeks for phototherapy,
- •- *2 weeks for topical therapy (including steroids, retinoids, nitrogen mustard or
- •imiquimod). Topical steroids (maximum strength: Class III according to World Health Organization Classification of Topical Corticosteroids) and/or oral
- •steroids (* 10 mg prednisone equivalent/day) are allowed, if the patient has been
- •on a stable dose with stable disease for at least 1 month prior to study entry.
- •4) At least 18 years of age.
- •5) ECOG performance status of * 2.
- •6) Adequate baseline laboratory data: hemoglobin >9 g/dL, absolute neutrophil count
- •(ANC) *1,000/*L, CD4+ T-cells *200/*l, platelets *50,000/*L, bilirubin *1.5 X upper
- •limit of normal (ULN) or *3 X ULN for patients with Gilbert's disease, serum creatinine
- •*1.5 X ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- •7) Women of childbearing potential (WOCBP) must have a negative serum beta-HCG
- •pregnancy test result within seven days of treatment and must practice an effective
- •method of contraception during treatment and for at least 9 months (270 days) following the last dose of study drug.
- •8) Female patients who are post-menopausal or surgically sterile.
- •9) Male patients who agree to practice effective barrier contraception.
- •10) Ability to understand and the willingness to sign a written informed consent document.
- •11) No psychological, familial, sociological, or geographical condition potentially
- •hampering compliance with the study protocol and follow-up schedule.
排除标准
- •1) Patients with limited disease (if MF/SS: stages IA), or central nervous system (CNS)
- •2) Clinical relevant AEs or laboratory results related to previous anti-neoplastic therapy
- •have not resolved to a NCI-CTCAE grade *1.
- •3) Concomitant corticosteroid use, systemic or topical, for treatment of skin disease.
- •However, topical steroids (maximum strength: Class III according to World Health Organization Classification of Topical Corticosteroids) and/or oral steroids
- •(*10 mg prednisone equivalent/day) are allowed, if patient has been on a stable dose
- •with stable disease for at least 4 weeks prior to study entry.
- •4) Patients who have undergone major surgery < 4 weeks prior to starting study drug
- •5) Patients who have undergone a stem cell transplantation
- •6) Patients with known NCI CTCAE Grade 3 or higher (requiring IV antibiotics) active
- •systemic or cutaneous viral, bacterial, or fungal infection.
- •7) Patients who are Hepatitis B or Hepatitis C antibody positive.
- •8) Patients who are known to be HIV-positive.
- •9) Prior hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or
- •immunotherapy.
- •10) Patients with a history of other malignancies during the past three years. (The
- •following are exempt from the three-year limit: non-melanoma skin cancer,
- •Lymphomatoid papulosis, curatively treated localized prostate cancer, curatively
- •treated localized breast cancer, resected thyroid cancer, cervical intraepithelial
- •neoplasia or cervical carcinoma in situ on biopsy).
- •11) Patients who are currently pregnant or breastfeeding.
- •12) Patients with congestive heart failure, Class III or IV, by New York Heart Association
- •(NYHA) criteria.
- •13) Patients with any serious underlying medical condition that would impair their ability to
- •receive or tolerate the planned treatment.
- •14) Patients with dementia or altered mental status that would preclude understanding
- •and rendering of informed consent document.
研究者
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