Overview
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.
Description
This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate efficacy，safety and pharmacokinetics(PK) of relma-cel.
Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10^8 CAR+T cells.The indication for this application is R/R LBCL and the recommended dose is 1×10^8 CAR+T cells.
Eligibility
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-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT);
- Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
- Adequate organ function;
- Adequate vascular access for leukapheresis procedure;
- Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
- Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
- Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.
Exclusion Criteria:
- Primary CNS lymphoma;
- History of another primary malignancy that has not been in remission for at least 2 years;
- Subjects has HBV,HCV,HIV or syphilis infection at the time of screening;
- Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-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 CNS pathology;
- Pregnant or nursing woman;
- Subjects using of any chemotherapy,corticosteroid,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
- 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.