Trial Search Results

A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma

Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of KTE-X19 in subjects with Relapsed/Refractory MCL

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Kite, A Gilead Company

Stanford Investigator(s):


  • Biological: KTE-X19
  • Drug: Cyclophosphamide
  • Drug: Fludarabine


Phase 2


Key Inclusion Criteria:

Up to 5 prior regimens for mantle cell lymphoma (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) > 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 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


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting