Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
CD19-targeted Chimeric Antigen Receptor(CAR) T Cells
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥18 years old;
Sign on the informed consent;
Subjects must have histologically confirmed Large B-cell Lymphoma;
Subjects had been treated with anthracyclines and rituximab(or other CD20-targetedantibodies) and had relapsed, failed to respond, or progressed after at least twolines of therapy include autologous hematopoietic stem celltransplantation(auto-HSCT);
Subjects have accessible PET-positive lesion and have measurable CT-positive lesionaccording to Lugano Classification;
Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
Adequate organ function;
Adequate vascular access for leukapheresis procedur;
Subjects who have previously received CD19 targeted therapy must confirm thatlymphoma lesions still expresss CD19;
Women of childbearing potential must agree to use highly effective methods ofcontraception for 1 year after the last dose of Relma-cel;
Males who have partners of childbearing potential must agree to use an effectivebarrier contraceptive method for 1 year after the last dose of Relma-cel.
Exclusion
Exclusion Criteria:
Central nervous system(CNS) only involvement by malignancy or primary CNS lymphoma;
History of another primary malignancyn that has not been in remission for at least 2years;
Subjects has HBV,HCV,HIV or syphilis nefection at the time of screening;
Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requiresanti-coagulation within 3 months prior to signing the ICF;
Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
Presence of acute or chronic graft-versus-host disease(GVHD);
History of any serious cardiovascular disease or presence of clinically relevant CNSpathology;
Pregnant or nursing woman;
Subjects using of any chemotherapy,corticisteriod,experiment agents,GVHDtherapies,radiation,allo-HSCT or any other therapies for lymphoma must go through aspecific wash-out period before leukapheresis;
Uncontrolled conditions or unwillingness or inability to follow the proceduresrequired in the protocol;
Received CAR T-cell or other genetically-modified T-cell therapy previously.
Study Design
Study Description
Connect with a study center
Tianjin Cancer Hospital
Tianjin, Tianjin 300060
ChinaSite Not Available

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