2023-504795-20-00招募中1 期
A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms
AbbVie Deutschland GmbH & Co. KG, AbbVie Deutschland GmbH & Co. KG16 个研究点 分布在 6 个国家目标入组 6 人开始时间: 2023年11月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 16
- 主要终点
- The primary endpoints are safety and tolerability, including AESIs of Cytokine Release Syndrome (CRS), Immune Cell-Associated Neurotoxicity Syndrome (ICANS), and Clinical Tumor Lysis Syndrome (CTLS), and PK parameters of epcoritamab monotherapy.
研究概览
简要总结
The primary objectives of the study are to evaluate the safety and PK profile of epcoritamab monotherapy in pediatric patients (and young adults) with relapsed/refractory Burkitt's or Burkitt-like lymphoma/leukemia, DLBCL, or other aggressive mature (CD20+) B-cell lymphomas who have failed to reach remission with re-induction therapy or who are unable to receive further consolidation with cell therapy.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects or their legally authorized representative, if permitted, must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. For those subjects who have not reached the age of consent, parent or legal guardian with the willingness and ability to provide written informed consent and subject willing and able to give assent, as appropriate for age and country. Subjects must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care). Investigator's discretion should be applied.
- •Male or female subjects, ≥ 1 and < 18 years old at the time of primary diagnosis. - Subjects up to 25 years old with diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.
- •Subject must be able to tolerate subcutaneous injections.
- •Disease pathologically confirmed (tumor tissue) by local testing.
- •Relapsed or primary refractory disease meeting any of the following criteria: Progressive disease at any time during second-line chemoimmunotherapy (CIT). Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT. Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT. Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy. Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT. Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR.
- •Recovery from toxic effects of prior chemoimmunotherapy.
- •Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2 .
- •Adequate bone marrow, hepatic, and renal function.
排除标准
- •Known CNS involvement by lymphoma at screening as confirmed by screening MRI/CT/PET brain scans (patients with evidence of CNS disease only in the CSF will be eligible).
- •Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.
- •Other malignancy requiring therapy.
结局指标
主要结局
The primary endpoints are safety and tolerability, including AESIs of Cytokine Release Syndrome (CRS), Immune Cell-Associated Neurotoxicity Syndrome (ICANS), and Clinical Tumor Lysis Syndrome (CTLS), and PK parameters of epcoritamab monotherapy.
The primary endpoints are safety and tolerability, including AESIs of Cytokine Release Syndrome (CRS), Immune Cell-Associated Neurotoxicity Syndrome (ICANS), and Clinical Tumor Lysis Syndrome (CTLS), and PK parameters of epcoritamab monotherapy.
次要结局
- CR per the International Pediatric Non-Hodgkin Lymphoma Response Criteria
- Event-free survival (EFS)
- Overall survival (OS)
- Rate of initiation of stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy
- Overall response (OR)
- Duration of response (DOR)
- Duration of CR (DOCR)
- Immunogenicity ([ADA] and neutralizing anti-drug antibodies (nAb))
研究者
Global Clinial Trial Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (16)
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