cd19-targeted car t cells for relapsed and refractory (r/r) large b-cell lymphoma

Conditions: Lymphoma, Non-Hodgkin; Diffuse Large B Cell Lymphoma

Summary: 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.

this is an open-label, single-arm study conducted in adult subjects with r/r lbcl in china to evaluate the pharmacokinetics(pk), safety and efficacy of relma-cel, monitor the immune response after relma-cel treatment. 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(supplement study) and the recommended dose is 1×10\^8 car+t cells.

Eligibility criteria:
inclusion criteria: 1. ≥18 years old; 2. sign on the informed consent; 3. subjects must have histologically confirmed large b-cell lymphoma; 4. 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 include autologous hematopoietic stem cell transplantation(auto-hsct); 5. subjects have accessible pet-positive lesion and have measurable ct-positive lesion according to lugano classification; 6. eastern cooperative oncology group(ecog) performance status of 0 or 1; 7. adequate organ function; 8. adequate vascular access for leukapheresis procedur; 9. subjects who have previously received cd19 targeted therapy must confirm that lymphoma lesions still expresss cd19; 10. women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of relma-cel; 11. 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: 1. central nervous system(cns) only involvement by malignancy or primary cns lymphoma; 2. history of another primary malignancyn that has not been in remission for at least 2 years; 3. subjects has hbv,hcv,hiv or syphilis nefection at the time of screening; 4. active deep venous thrombosis(dvt)/pulmonary embolism(pe),or active dvt/pe requires anti-coagulation within 3 months prior to signing the icf; 5. subjects with uncontrolled systemic fungal,bacterial,viral or other infection; 6. presence of acute or chronic graft-versus-host disease(gvhd); 7. history of any serious cardiovascular disease or presence of clinically relevant cns pathology; 8. pregnant or nursing woman; 9. subjects using of any chemotherapy,corticisteriod,experiment agents,gvhd therapies,radiation,allo-hsct or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; 10. uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; 11. received car t-cell or other genetically-modified t-cell therapy previously.

Keywords: jwcar029 b-cell malignancies car t cells chimeric antigen receptor relapsed/refractory