Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory aggressive Non-Hodgkin Lymphoma (NHL).

Official Title

A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1)

Keywords

Refractory Diffuse Large B Cell Lymphoma Refractory Primary Mediastinal B Cell Lymphoma Refractory Transformed Follicular Lymphoma Relapsed/Refractory Transplant Ineligible Diffuse Large B Cell Lymphoma Relapsed/Refractory Transplant Ineligible Primary Mediastinal B Cell Lymphoma Relapsed/Refractory Transplant Ineligible Transformed Follicular Lymphoma Relapsed/Refractory Large B Cell Lymphoma Including DLBCL, PMBCL, TFL and HGBCL After Two Systemic Lines of Therapy" in Phase 2 Expanded Cohorts Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse axicabtagene ciloleucel

Eligibility

For people ages 18 years and up

Key Inclusion Criteria

  1. Histologically confirmed:
  2. Diffuse Large B Cell Lymphoma (DLBCL)
  3. Primary Mediastinal Large B Cell Lymphoma (PMBCL)
  4. Transformation Follicular Lymphoma (TFL)
  5. High grade B-cell lymphoma (HGBCL)
  6. Chemotherapy-refractory disease, defined as one of more of the following:
  7. No response to last line of therapy i. PD as best response to most recent therapy regimen ii. SD as best response to most recent therapy with duration no longer than 6 month from last dose of therapy OR
  8. Refractory post-ASCT i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed subjects) ii. If salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy
  9. Subjects must have received adequate prior therapy including at a minimum:
  10. anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and
  11. an anthracycline containing chemotherapy regimen
  12. for subjects with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL
  13. At least one measurable lesion per revised IWG Response Criteria
  14. Age 18 or older
  15. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  16. ANC ≥ 1000/uL
  17. ALC >100/uL
  18. Platelet count ≥ 75,000/uL
  19. . Adequate renal, hepatic, pulmonary and cardiac function defined as:
  20. Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min
  21. Serum ALT/AST <2.5 ULN
  22. Total bilirubin <1.5 mg/dl, except in subjects with Gilbert's syndrome
  23. Cardiac ejection fraction >50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant pleural effusion
  24. Baseline oxygen saturation >92% on room air
  25. . All subjects or legally appointed representatives/caregivers, must personally sign and date the IRB/IEC approved consent form before initiating any study specific procedures or activities.

Key Exclusion Criteria

  1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g.cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
  2. History of allogeneic stem cell transplantation
  3. Prior CAR therapy or other genetically modified T cell therapy
  4. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment
  5. History of HIV infection or acute or chronic active hepatitis B or C infection.Subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines
  6. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma or primary CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases
  7. History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement

Locations

  • UC San Diego Moores Cancer Center in progress, not accepting new patients
    La Jolla California 92093 United States
  • City of Hope in progress, not accepting new patients
    Duarte California 91010 United States
  • UCLA Medical Center in progress, not accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kite, A Gilead Company
ID
NCT02348216
Phase
Phase 1/2
Study Type
Interventional
Last Updated
May 25, 2018