Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL
Lymphoma, Large B-Cell, Diffuse, Follicular Lymphoma Grade 3B, High-grade B-cell Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse focused on measuring Relmacabtagene Autoleucel, aggressive B-cell non-Hodgkin lymphoma, Chimeric antigen receptor T cells, second-line
Eligibility Criteria
Inclusion Criteria: Age≥18 years; Signed written informed consent obtained prior to any study procedures; Histologically confirmed relapsed or refractory (R/R) aggressive B-cell NHL of the following histologiesLBCL as defined by the World Health Organization (WHO) Classification 2022:Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), high-grade B-cell lymphoma (HGL) with MYC and BCL2 rearrangements,HGL-NOS, Primary mediastinal large B-cell lymphoma, Follicular lymphoma Grade 3B (FL3B),Indolent B-NHL-transformed large B-cell lymphoma with adequate prior treatment with anthracycline-containing agents and rituximab or other CD20-targeted agents; Subjects must meet the definition of refractory or relapsed; Subjects were not eligible for HDCT/ASCT based on the investigator's assessment ; Adequate organ function; Presence of positive PET assessable lesions as determined by the Lugano criteria ; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Expected survival greater than 12 weeks; Adequate vascular access for leukapheresis procedure; Women of childbearing potential must agree to use highly effective methods of contraception for at least 28 days prior to lymphocyte clearance chemotherapy through 2 year after Relmacabtagene Autoleucel infusion; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 2 year after Relmacabtagene Autoleucel infusion; Exclusion Criteria: Subjects with non-Hodgkin's lymphoma who have received second or more line therapy; Lymphoma of the primary center (subjects with secondary central nervous system lymphoma are allowed to enroll; History of another primary malignancy that has not been in remission for at least 2 years; Subjects has active HBV, HCV, HIV or syphilis infection at the time of screening; Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; Subjects with uncontrolled systemic fungal, bacterial, viral or other infection; Uncontrolled diabetes and hypertension; Presence of acute or chronic graft-versus-host disease (GVHD); Active autoimmune disease requiring immunosuppressive therapy; History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; Pregnant or nursing women; Subjects Received an autologous or allogeneic hematopoietic stem cell transplant; Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; Received CAR T-cell or other genetically-modified T-cell therapy previously; Received live vaccination within 6 weeks prior to lymphocyte clearance chemotherapy; History of severe hypersensitivity reactions to any of the drug ingredients used in this study product.
Sites / Locations
- Sun Yat-sen University Cancer Hospital
- Henan Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- Hunan Cancer Hospital
- The First Affiliated Hospital of Soochow University
- Shandong Cancer Hospital
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
- Institute of Hematology&Hospital of Blood Disease CAMS
- Tianjin Cancer Hospital
- The First Affiliated Hospital of Zhejiang University School of Medicine
- Beijing Tongren Hospital
- Peking Union Medical College Hospital
- Jiangsu Provincial People's Hospital
Arms of the Study
Arm 1
Experimental
Relmacabtagene Autoleucel
Experimental: Relmacabtagene Autoleucel Participants will receive cyclophosphamide250 mg/m^2/day intravenously (IV) and fludarabine 25 mg/m^2/day IV conditioning chemotherapy for 3 days followed by Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1.