Trial Search Results

Study to Evaluate the Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Participants 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)

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Kite, A Gilead Company

Stanford Investigator(s):

Intervention(s):

  • Biological: brexucabtagene autoleucel
  • Drug: Cyclophosphamide
  • Drug: Fludarabine
  • Drug: Axicabtagene Ciloleucel

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting