NCT02601313

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)

Official Title:

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

Summary

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).

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.

Disease(s) and\or Condition(s)

Relapsed/Refractory Mantle Cell Lymphoma

Primary Purpose
  • TREATMENT
Intervention/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)
Sponsor
  • Kite, A Gilead Company