2022-501607-27-00招募中2 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)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Cellectis
- 入组人数
- 48
- 试验地点
- 14
- 主要终点
- For the dose-finding part: Incidence, nature and severity of AEs and SAEs Proportion of subjects in each dose-level cohort with DLT during the DLT Observation Period For the dose-expansion part: Incidence, nature, and severity of AEs and SAEs during the dose-expansion part Incidence, nature, and severity of AEs and SAEs associated with LD in dose-expansion part
研究概览
简要总结
For the Dose-Finding Part: To assess the safety and tolerability and determine the MTD and/or RP2D of UCART20x22 in subjects with R/R mature B-NHL
For the Dose-Expansion Part: To assess the safety and tolerability of UCART20x22 and confirm the RP2D in subjects with R/R LBCL
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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: o An 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
结局指标
主要结局
For the dose-finding part: Incidence, nature and severity of AEs and SAEs Proportion of subjects in each dose-level cohort with DLT during the DLT Observation Period For the dose-expansion part: Incidence, nature, and severity of AEs and SAEs during the dose-expansion part Incidence, nature, and severity of AEs and SAEs associated with LD in dose-expansion part
For the dose-finding part: Incidence, nature and severity of AEs and SAEs Proportion of subjects in each dose-level cohort with DLT during the DLT Observation Period For the dose-expansion part: Incidence, nature, and severity of AEs and SAEs during the dose-expansion part Incidence, nature, and severity of AEs and SAEs associated with LD in dose-expansion part
次要结局
- : For the dose-finding and dose-expansion parts: Investigator assessed ORR according to Lugano response criteria. PFS, OS, and DoR Incidence, nature, and severity of AEs and SAEs associated with LD, associated antitumor activity, and corresponding host T-cell recovery and CAR T-cell expansion
研究者
clinical trial information desk
Scientific
Cellectis
研究点 (14)
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