Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

The primary objective is to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL) in Cohort 3 of this study.

Official Title

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

Details

Study KTE-C19-102 (NCT02601313) enrolled participants with r/r MCL who have been treated with up to 5 prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and Cohort 2. However, to fulfill FDA Postmarketing Requirement Cohort 3 is added to the study. It will include participants with r/r MCL who have been treated with up to 5 prior regimens but have not received prior therapy with a BTKi. The primary analysis in Cohort 1 and Cohort 2 is already completed. Data for Cohort 3 will be analyzed separately. Therefore, this separate registration is only for Cohort 3. After the end of KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

Keywords

Relapsed/Refractory Mantle Cell Lymphoma Lymphoma Lymphoma, Mantle-Cell Cyclophosphamide Fludarabine Brexucabtagene autoleucel Brexucabtagene autoleucel (KTE-X19)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Up to 5 prior regimens for MCL. Prior therapy must have included anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy. Individuals must not have received prior therapy with a BTKi.
  • At least 1 measurable lesion
  • Platelet count ≥ 75,000/uL
  • Creatinine clearance (as estimated by Cockcroft Gault) ≥ to 60 cc/min
  • Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA), and no clinically significant electrocardiogram (ECG) findings
  • Baseline oxygen saturation > 92% on room air

You CAN'T join if...

  • Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). Individuals with a history of hepatitis infection must have cleared their infection as determined by 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.

Locations

  • University California Los Angeles (UCLA) accepting new patients
    Santa Monica California 90404 United States
  • City of Hope completed
    Duarte California 91010 United States
  • Stanford University accepting new patients
    Palo Alto California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kite, A Gilead Company
Links
Gilead Clinical Trials Website
ID
NCT04880434
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated