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Summary

for people ages 2–21 (full criteria)
at San Francisco, California and other locations
study started

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 relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in pediatric or adolescent subjects.

Official Title

A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-4)

Keywords

Acute Lymphoblastic Leukemia Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid

Eligibility

You can join if…

Open to people ages 2–21

  1. Relapsed or refractory B-precursor ALL defined as one of the following:
  2. Primary refractory disease
  3. Relapsed or refractory disease after first or later salvage therapy
  4. Relapsed or refractory disease after allogeneic transplant provided subject is at least 100 days from stem cell transplant at the time of enrollment
  5. Morphological disease in the bone marrow (≥ 5% blasts)
  6. Subjects with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
  7. Ages 2 to 21 at the time of Assent or Consent per IRB guidelines
  8. Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at the time of assent/consent) performance status ≥ 80 at screening
  9. Adequate renal, hepatic, pulmonary and cardiac function defined as:
  10. Creatinine clearance ≥ 60 cc/min
  11. Serum ALT/AST ≤ 2.5 x ULN
  12. Total bilirubin ≤ 1.5 x ULN
  13. Cardiac ejection fraction ≥ 50% and no clinically significant ECG findings
  14. Baseline oxygen saturation > 92% on room air

You CAN'T join if...

  1. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
  2. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g.cervix, bladder, breast) unless disease free for at least 3 years
  3. Presence of CNS-3 disease and CNS-2 disease with neurological changes
  4. History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome,Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
  5. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
  6. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.
  7. Primary immunodeficiency
  8. Known infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
  9. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
  10. . Prior medication:
  11. Prior CD19 directed therapy, including CAR+ T cell, BiTE, and antibody drug conjugate (ADC), with the exception of subjects who received KTE-C19 in this study and are eligible for re-treatment
  12. Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
  13. Donor lymphocyte infusion (DLI) within 28 days prior to enrollment
  14. Any drug used for GVHD within 4 weeks prior to enrollment
  15. . Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment
  16. . Live vaccine ≤ 6 weeks prior to start of conditioning regimen
  17. . Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.Females who have undergone surgical sterilization are not considered to be of childbearing potential
  18. . Subjects of both genders of child-bearing potential who are not willing to practice birth control from the time of consent through 6 months after the completion of KTE-C19

Locations

  • UCSF Benioff Childrens Hospital accepting new patients
    San Francisco, California, 94158, United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles, California, 90027, United States
  • City of Hope accepting new patients
    Duarte, California, 91010, United States
  • Children's Hospital of Orange County accepting new patients
    Orange, California, 92868, United States

Details

Status
accepting new patients
Start Date
Sponsor
Kite Pharma, Inc.
ID
NCT02625480
Phase
Phase 1/2
Lead Scientist
Michelle Hermiston
Study Type
Interventional
Last Updated
November 1, 2017
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