CTIS2022-501607-27-00招募中1 期
Open-label dose-finding and dose-expansion study to evaluate the safety, expansion, persistence, and clinical activity of UCART20x22 in subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Cellectis
- 入组人数
- 80
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
- •Age 18 to 80 years, - Adequate organ function (renal, liver, cardiac, pulmonary, bone marrow), - Negative serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection, Autologous hematopoietic stem cells must be available prior to the start of the LD regimen if the subject is considered high-risk for prolonged hematologic toxicity., - Negative test result for hepatitis c virus (HCV) and human immunodeficiency virus (HIV)., - Women of childbearing potential (WOCBP) must have a negative, highly sensitive serum pregnancy test performed within 7 days prior to enrollment., Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Relapsed or refractory (R/R) mature B-NHL per 2016 WHO criteria and positive for CD20 and/or CD22, - Subjects with NHL subtypes defined by WHO •Dose-finding part: R/R mature B-NHL (except chronic lymphocytic leukemia/small lymphocytic leukemia [CLL/SLL], Richter’s transformation from prior CLL/SLL, Burkitt’s lymphoma, and Waldenstrom’s macroglobulinemia) •Dose-expansion Part: R/R LBCL defined as: o DLBCL o High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements o Transformed FL or transformed marginal zone lymphoma (MZL) o Follicular lymphoma Grade 3B, - R/R disease after at least 2 lines of prior treatment, which must have included: oAn Anti-CD20 MoAb and an anthracycline for DLBCL, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, primary mediastinal large B-cell lymphoma (PMBCL), or transformed FL or MZL o An alkylating agent in combination with an anti-CD20 MoAb for FL o An anthracycline or bendamustine-containing chemotherapy regimen and a Bruton’s tyrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL) o Autologous anti-CD19 CAR T-cell therapy, if approved and available for the indicated lymphoma subtype, unless the subject is unable or is ineligible to receive approved autologous anti-CD19 CAR T-cell therapy., - At least 1 measurable lesion according to the Lugano Response Criteria for Malignant Lymphoma, - Prior lymphoma treatment-related toxicities resolved to baseline or = Grade 1 prior to start of LD regimen
排除标准
- •Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusion within 6 weeks of the start of LD, Known hypersensitivity to any of the test materials or related compounds including murine and bovine products, History of hypersensitivity to alemtuzumab, History of neutralizing anti-drug antibody against alemtuzumab, Any known uncontrolled cardiovascular disease within 3 months of enrollment, Subjects requiring immunosuppressive treatment, Major surgery within 28 days prior to start of LD, Evidence of another uncontrolled malignancy within 2 years prior to Screening (except in situ nonmelanoma skin cell cancers and/or carcinoma in-situ of the cervix), Positive SARS-CoV2 viral PCR test within 3 days prior to initiation of LD, Prior use of an investigational product (except for cell or gene therapies and MoAbs) within 5 half-lives or within 14 days, whichever is shorter, prior to start of LD regimen, Previous approved therapy including chemotherapy, biologic (except MoAbs), or targeted therapy for R/R B-NHL with 5 half-lives or within 14 days, whichever is shorter, prior to start of the LD regimen, Active acute or chronic GvHD. Subjects should be off all immunosuppressive therapies for at least 6 weeks prior to start of LD, Prior MoAb therapy (approved or investigational) within 30 days prior to start of LD, Prior systemic immunostimulatory agent within 3 half-lives prior to start of the LD regimen, Prior cell or gene therapy (approved or investigational) within 6 weeks of the start of LD, Prior cell or gene therapy (approved or investigational) targeting both CD20 and CD22, Autologous HSCT infusion within 6 weeks of the start of LD, Radiotherapy within 8 weeks (except for palliative radiotherapy for specific on-target lesions) (prior to start of LD regimen), Evidence of active central nervous system (CNS) lymphoma or previous CNS involvement of R/R B-NHL, Presence of an active and clinically relevant CNS disorder, Daily treatment with >20 mg prednisone or equivalent, Known active infection, or reactivation of a latent infection, whether bacterial or viral, fungal, mycobacterial, or other pathogens, History of recurrent significant viral infection, Inability for any reason to receive appropriate antimicrobial prophylaxis against Pneumocystis jiroveci, herpes, viruses, and invasive fungal infections
研究者
相似试验
招募中
1 期
A Phase 1/2a Study of UCART22 in B-cell Acute Lymphoblastic Leukemia (BALLI-01)Relapsed or refractory B-cell Acute LymphoblasticLeukemiaCTIS2022-502305-15-00Cellectis113
进行中（未招募）
1 期
Study to evaluate the safety and efficacy of UCART22 in patients with Acute Lymphoblastic Leukaemia that have relapsed or not responded to other treatmentsAcute Lymphoblastic Leukaemia.MedDRA version: 21.0Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864EUCTR2020-004768-24-FRCELLECTIS SA83
招募中
不适用
Safety and tolerability evaluation study of BVAC-C in patients with HPV type 16 or 18 positive cervical cancer after failure to standard careNeoplasmsKCT0002115Cellid9
尚未招募
1 期
A study to test how well different doses of BI 3706674 are tolerated by people with advanced cancer in the stomach and oesophagusGAC, EAC, and GEJAC solid tumours harbouring a KRAS wt amplification Solid tumours of any histologyGAC, EAC, and GEJAC solid tumours harbouring a KRAS wt amplificationJPRN-jRCT2030230282Kurei Katsutoshi146
招募中
1 期
A study to test how well different doses of BI 3706674 are tolerated by people with advanced cancer in the stomach and oesophagusGAC, EAC, and GEJAC solid tumours with KRAS wt amplification, Solid tumours of any histologyJPRN-jRCT2030230343akahara Asuka15