Study to Evaluate the Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Patients with relapsed or refractory mantle cell lymphoma (b-cell lymphoma) who have received standard therapies that have ceased to be effective will be recruited to receive treatment with a new experimental therapy (KTE-C19). Patients will receive 3 doses of chemotherapy before undergoing leukapheresis, a procedure where blood is removed and divided into red and white cells, plasma and platelets. The red blood cells, plasma and platelets are then returned to the patients and the white cells are sent to a laboratory to be modified and grown. They will then be infused back into the patient. There will be a 28 day screening period, the patient will then undergo leukapheresis and received 3 doses of chemotherapy. They will be admitted to the hospital and remain for 7 days. They will return to the clinic at regular intervals for follow up and they will be followed for up to 15 years for survival status.
Adult subjects who have been diagnosed with Mantel Cell Lymphoma that has been in a period of improvement but is now worsening (relapsed) or whose disease is resistant to standard treatment (refractory.) Patient diagnosed with a tumor deemed eligible by the attending physician. For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Key Inclusion Criteria:
Up to 5 prior regimens for MCL. Prior therapy must have included:
- Anthracycline or bendamustine-containing chemotherapy and
- Anti-CD20 monoclonal antibody therapy and
- Ibrutinib or acalabrutinib At least 1 measurable lesion Platelet count ≥ 75,000/uL Creatinine clearance (as estimated by Cockcroft Gault) > or = to 60 mL/min Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings Baseline oxygen saturation >92% on room air.
Key Exclusion Criteria:
- Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.