NCT02601313
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
PHASE2
COMPLETED
NCT02601313
INTERVENTIONAL
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Relapsed/Refractory Mantle Cell Lymphoma
- TREATMENT
-
- Type: BIOLOGICAL
- Name: brexucabtagene autoleucel
- Description: A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells
- Arm Group Labels: Axicabtagene ciloleucel/brexucabtagene autoleucel (KTE-X19)
-
- Type: DRUG
- Name: Cyclophosphamide
- Description: Administered intravenously
- Arm Group Labels: Axicabtagene ciloleucel/brexucabtagene autoleucel (KTE-X19)
-
- Type: DRUG
- Name: Fludarabine
- Description: Administered intravenously
- Arm Group Labels: Axicabtagene ciloleucel/brexucabtagene autoleucel (KTE-X19)
-
- Type: DRUG
- Name: Axicabtagene Ciloleucel
- Description: A single infusion of axicabtagene ciloleucel anti-CD 19 CAR T cells
- Arm Group Labels: Axicabtagene ciloleucel/brexucabtagene autoleucel (KTE-X19)
- Kite, A Gilead Company