Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Aaron Logan

Description

Summary

The primary objectives of this study are to determine the safety and efficacy of KTE-C19 adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).

Official Title

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)

Keywords

Acute Lymphoblastic Leukemia Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Cyclophosphamide Fludarabine phosphate Fludarabine KTE-C19

Eligibility

For people ages 18 years and up

Key Inclusion Criteria:

  1. Relapsed or refractory B-precursor ALL defined as one of the following:
  2. Primary refractory disease
  3. First relapse if first remission ≤ 12 months
  4. Relapsed or refractory disease after 2 or more lines of systemic therapy
  5. Relapsed or refractory disease after allogeneic transplant provided individuals is at least 100 days from stem cell transplant at the time of enrollment
  6. Morphological disease in the bone marrow (≥ 5% blasts)
  7. Individuals 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
  8. Age 18 or older
  9. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  10. Adequate renal, hepatic, pulmonary and cardiac function defined as:
  11. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min
  12. Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
  13. Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilbert's syndrome.
  14. Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion, and no clinically significant arrhythmias
  15. Baseline oxygen saturation > 92% on room air
  16. In individuals previously treated with blinatumomab, CD19 tumor expression in bone marrow or peripheral blood.

Key Exclusion Criteria:

  1. Diagnosis of Burkitt's leukemia/lymphoma according to World Health Organization (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. Isolated extramedullary disease
  4. Central nervous system (CNS) abnormalities
  5. Presence of CNS-3 disease or CNS-2 disease with neurological changes
  6. History or presence of any CNS disorder such as a seizure disorder,cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
  7. History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome,Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
  8. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
  9. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.
  10. Primary immunodeficiency
  11. Known infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive).
  12. . Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
  13. . Prior medication:
  14. Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment
  15. Prior CD19 directed therapy other than blinatumomab
  16. Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
  17. Donor lymphocyte infusion (DLI) within 28 days prior to enrollment
  18. Any drug used for graft-versus-host disease (GVHD) within 4 weeks prior to enrollment
  19. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy prior to enrollment
  20. Corticosteroid therapy for 7 days prior to enrollment
  21. . Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube,indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter).Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
  22. . 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
  23. . Live vaccine ≤ 4 weeks prior to enrollment
  24. . 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 or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
  25. . Individuals 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
  26. . In the investigators judgment, the individuals is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
  27. . History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus)resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist

  • Aaron Logan
    The phone number listed above is my direct office number. If you prefer to contact the outpatient clinic, please call 415-353-2421. The clinic fax number is 415-353-2467.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kite, A Gilead Company
ID
NCT02614066
Phase
Phase 1/2
Study Type
Interventional
Last Updated