Phase I/II, open-label, multi-center study to evaluate the safety and efficacy of glyco-humanized polyclonal antibody directed against tumoral T cells, in patients with relapsed/refractory peripheral T cells lymphoma (PTCL). - XT 23-10

Xenothera0 个研究点目标入组 15 人开始时间: 2023年12月28日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Xenothera
入组人数: 15

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

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Provide signed, written informed consent, Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., Has life expectancy of >3 months, Has an adequate hematological and organ function at screening, including: •Hemoglobin =8.0 g/dL (prior transfusion is acceptable) •Absolute neutrophil count (ANC) =1000 cells/mm3 (without growth factor support within 7 days of ANC measurement) •Platelet count =50,000 cells/mm3 (without growth factor support or transfusion within 7 days of platelets measurement) •Creatinine clearance =30 mL/min •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 × the upper limit of normal (ULN) •Serum total bilirubin <2 × ULN OR <3 × ULN (for participants with Gilbert’s Syndrome), Participants must be able to understand and sign an informed consent form., All participants must use adequate contraception during participation in this study and for 6 months following completing therapy., Is male or female, age =18 years old (at the time consent is obtained), For Part 1: Has a histological diagnosis of the following relapsed or refractory PTCL based on WHO 2022 classification of lymphoid neoplasms •Intestinal T-cell and NK cell lymphoid proliferations and lymphomas (without NK cell neoplasms) •Hepatosplenic T-cell lymphoma •Anaplastic large cell lymphoma •Nodal TFH cell lymphoma •Other peripheral t-cell lymphomas. For Part 2: The type of PTCL will be defined based on SC review after completion of Part 1 and will be documented in the protocol amendment, Had previously received 1 or more appropriate systemic therapies, including an alkylating agent and/or anthracycline, for treatment of the current disease (radiation therapy alone would not be acceptable as previous therapy). Participants with ALCL must have received prior brentuximab vedotin or be unable to receive it due to allergy or intolerance., Experienced disease progression during or after completion of most recent therapy or refractory disease, Has a measurable lesion by imaging: the longest diameter should be =1.5 cm for nodal lesions and >1 cm for extra-nodal lesions., Experienced a toxicity of prior therapy: Participants must have recovered to less than Grade 1 or to baseline from toxicity of prior chemotherapy or biologic therapy and must not have had major surgery, chemotherapy, radiation, or biologic therapy within 2 weeks prior to beginning treatment. Note: Exceptions to this include events not considered to place the participant at unacceptable risk of participation in the opinion of the Investigator (e.g., alopecia)., Has either unstained tissues (block or unstained slides) or stained slides and pathology report available for central review. If stained slides or unstained tissue are not available or insufficient, a fresh tumor tissue sample is mandatory for central pathology. Central pathology confirmation is not required prior to enrollment., Is able to provide a bone marrow aspirate and/or a biopsy no older than 3 months at screening and agrees to undergo post-treatment bone marrow aspirate or biopsy when required to confirm response.

排除标准

•Is diagnosed with a bulky disease (=10 cm), Has a cognitive impairment, active substance abuse, or psychiatric illness or social situations that, in the view of the Investigator, would preclude safe treatment or the ability to give informed consent and limit compliance with study requirements., Has a known history of drug-induced liver injury, alcoholic liver disease, non- alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension., Has known history or presence of central nervous system involvement by leukemia or lymphoma., Has a hemophilia or von Willebrand’s disease., Has any psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol., Has a concurrent condition that, in the Investigator’s opinion, would jeopardize compliance with the protocol., Are unable or unwilling to comply with study and/or follow-up procedures outlined in the protocol., For France, participants under legal protection (safeguard, guardianship, curatorship)., Is currently participating in another therapeutic clinical study., Has Mature T-cell and NK-cell leukemias (WHO 2022 criteria), Has a known infection with human immunodeficiency virus (HIV) or serologic status reflecting active hepatitis B or C infection as follows: •Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible only if hepatitis B virus (HBV) DNA is undetectable by an assay with sensitivity <20 IU/mL. If so, participants may either undergo regularly scheduled monitoring of HBV DNA or less frequent monitoring of HBV DNA while on prophylactic antiviral medication as defined by regional standard of care. •Presence of hepatitis C virus (HCV) antibody. Participants with presence of HCV antibody are eligible only if HCV RNA is undetectable., Has T-lymphoblastic leukemia/lymphoma (WHO 2022 criteria), Has tumor-like lesions with T-cell predominance (WHO 2022 criteria), Has Primary cutaneous T-cell lymphomas (WHO 2022 criteria), Has any other active cancers, or history of treatment for invasive cancer =3 years. Note: Participants with stage I cancer who have received definitive local treatment at least 3 years previously and are considered unlikely to recur are eligible. All participants with previously treated in situ carcinoma (i.e., non-invasive) are eligible., Received any of the following treatments prior to the first dose of study medication: •Systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks (or 5 half-lives, whichever is shorter) before Cycle 1 Day 1. Participants that received local radiation therapy are eligible. •Therapeutic anti-cancer antibodies <4 weeks •Any investigational drug in the last 4 weeks prior •Any major surgery or immunotherapy within 28 days •Toxin immunoconjugates <4 weeks •Nitrosoureas <6 weeks •Allogeneic hematologic stem cell transplant within 3 months •Adaptive cellular therapy such as autologous or donor natural killer cell or T lymphocyte infusions within 90 days •Systemic corticosteroids (prednisone or equivalent >10 mg daily) within 2 weeks prior to the start of therapy, or 12 weeks if given to treat graft versus host disease (GVHD), except for physiological replacement doses of cortisone acetate or equivalent •Systemic treatment for GVHD (including but not limited to or

研究者

发起方

Xenothera

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