A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma - GCT3013-01

Genmab A/S0 个研究点目标入组 682 人开始时间: 2024年1月8日最近更新: 2024年8月21日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Genmab A/S
入组人数: 682

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

•1. Patient must be 18 years of age or older (for expansion: In countries where the legal age is 21 years of age; only patients 21 years of age or older are eligible) 2. Documented CD20+ mature non-Hodgkin B-cell lymphoma according to WHO classification 3. Relapsed, progressive and/or refractory disease (Cheson et al., 2007) following treatment with an anti-CD20 monoclonal antibody 4. Patients must have received at least 2 prior lines of therapy 5. Patients must have measurable disease by imaging 6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. For MCL: ECOG PS <2 required for participation. 7. For the optimization part, patients must have R/R DLBCL, or FL grades 1-3A, or MCL (according to cohort).

排除标准

•1. Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma 2. AST, and/or ALT > 3 x upper limit of normal 3. Total bilirubin > 1.5 x upper limit of normal 4. Creatinine clearance < 45 mL/min 5. Known clinically significant cardiac disease, including: a. Onset of unstable angina pectoris within 6 months of signing ICF b. Acute myocardial infarction within 6 months of signing ICF c. Congestive heart failure (grade III or IV as classified by the New York Heart Association and/or known decrease ejection fraction of < 45% 6. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrolment or within the previous 2 weeks prior to the first dose of epcoritamab, including COVID-19 infection. 7. Eligible for curative salvage therapy with high dose therapy followed by stem cell rescue 8. Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR positive infection). Subjects with evidence of prior HBV but who are PCRnegative are permitted in the trial but should receive prophylactic antiviral therapy. 9. Known human immunodeficiency virus (HIV) infection. 10. Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF 11. Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first GEN3013 administration 12. Autologous HSCT within 100 days prior to first GEN3013 administration, or any prior allogeneic HSCT or solid organ transplantation 13. Contraindication to all uric acid lowering agents

研究者

发起方

Genmab A/S

相似试验

进行中（未招募）

1 期

A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell LymphomaRelapsed, progressive and/or refractory mature B-cell lymphomaPatients with: - Diffuse large B-cell lymphoma – de novo or transformed - High-grade B-cell lymphoma - Primary mediastinal large B-cell lymphoma - Follicular lymphoma - Mantle cell lymphoma - Small lymphocytic lymphoma - Marginal zone lymphoma (nodal, extranodal or mucosaassociated)MedDRA version: 21.0Level: PTClassification code 10003903Term: B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2017-001748-36-FIGenmab A/S786

进行中（未招募）

1 期

A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell LymphomaRelapsed, progressive and/or refractory mature B-cell lymphomaPatients with: - Diffuse large B-cell lymphoma – de novo or transformed - High-grade B-cell lymphoma - Primary mediastinal large B-cell lymphoma - Follicular lymphoma - Mantle cell lymphoma - Small lymphocytic lymphoma - Marginal zone lymphoma (nodal, extranodal or mucosa associated)MedDRA version: 21.0Level: PTClassification code 10003903Term: B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2017-001748-36-ITGENMAB A/S386

进行中（未招募）

1 期

A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma

EUCTR2017-001748-36-SEGenmab A/S786

进行中（未招募）

1 期

EUCTR2017-001748-36-FRGenmab A/S386

进行中（未招募）

1 期

EUCTR2017-001748-36-DKGenmab A/S786