Study to Evaluate the Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma

  • Interventional
  • Not Recruiting
  • NCT02601313
Eligibility Details Visit Clinicaltrials.gov

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

The primary objective of the study is to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in participants with relapsed/refractory mantle cell lymphoma (MCL)

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT02601313

IRB#IRB15-1146

Lead SponsorKite, A Gilead Company

Lead PhysicianMichael R. Bishop

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting