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Clinical Trials/EUCTR2015-005010-30-BE
EUCTR2015-005010-30-BEActive, not recruitingPhase 1

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)P/142/2020 - ZUMA-4

Kite Pharma, Inc.0 sites116 target enrollmentStarted: May 5, 2021Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
116
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •101. Relapsed or refractory B-precursor ALL defined as one of the following:
  • •- Primary refractory disease
  • •- Any relapse within 18 months after first diagnosis (this criterion does not apply to Germany, refer to Appendix 8 for details)
  • •- Relapsed or refractory disease after 2 or more lines of systemic therapy
  • •- Relapsed or refractory disease after allogeneic transplant provided subject is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment
  • •102. Disease burden defined as at least 1 of the following:
  • •-Morphological disease in the bone marrow (>5% blasts)
  • •-MRD positive (threshold 10-4 by flow or PCR)
  • •103. 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
  • •104. Age = 21 years and weight = 6 kg.
  • •111. In subjects previously treated with blinatumomab, CD19 tumor expression on blasts obtained from bone marrow or peripheral blood must be documented after completion of the most recent prior line of therapy and blasts must be = 90% CD19 positive.
  • •301. Histologically confirmed aggressive B cell NHL:
  • •- DLBCL not otherwise specified
  • •- Primary mediastinal large B-cell lymphoma (including Mediastinal gray zone lymphoma)
  • •- Burkitt lymphoma/leukemia, Burkitt-like lymphoma and Unclassified B-cell lymphoma intermediate between DLBCL and Burkitt lymphoma
  • •302. Relapsed or refractory disease defined as 1 or more of the following:
  • •- Primary refractory disease
  • •- Any relapse within 18 months after first diagnosis
  • •- Relapsed or refractory disease after 1 or more lines of systemic therapy
  • •- Relapsed or refractory disease after autologous /allogeneic SCT provided subject is at least 6 weeks from autologous SCT and at least 3 months from allogeneic SCT at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment
  • •303. Subjects must have received adequate prior therapy including at a minimum all of the following:
  • •- Anti-CD20 monoclonal antibody, unless the investigator determines that the tumor is CD20 negative
  • •- An anthracycline-containing chemotherapy regimen
  • •304. At least 1 measurable lesion according to the revised International Pediatric Non-Hodgkin Lymphoma Staging System {Rosolen 2015} or isolated bone marrow disease and/or isolated CNS disease per Additional Staging Information for the International Pediatric NHL Staging System (Appendix 6). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
  • •307. Age <18 years old and weight > or = 6kg
  • •Note: Subjects with a weight of = 6 kg to < 10kg will only be included once a pediatric formulation becomes available.
  • •Both Cohort
  • •105. and 308. Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age > or = 16 years at the time of assent/consent) performance status > or = 80 at screening
  • •106. and 309. ANC > or = 500/uL unless, in the opinion of the PI, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy
  • •107. and 310. Platelet count > or = 50,000/uL unless, in the opinion of the PI, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy
  • •108. and 311. Absolute lymphocyte count > or = 100/µL

Exclusion Criteria

  • •201. Diagnosis of Burkitt’s leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
  • •202. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg. cervix, bladder, breast) unless disease free for at least 3 years
  • •205. History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, or Shwachman-Diamond syndrome
  • •206. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
  • •401. History of malignancy other than nonmelanoma skin cancer, carcinoma in situ (eg, cervix, breast), or FL unless disease free for at least 3 years
  • •402. Autologous SCT within < 6 weeks of planned KTE-X19 infusion; allogeneic SCT within < 3 months of planned KTE-X19 infusion.
  • •403. Prior CD19 targeted therapy other than blinatumomab and loncastuximab tesirine-lpyl.
  • •404. Prior CAR therapy or other genetically modified T Cell therapy
  • •409. 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.
  • •Both Cohort
  • •204. and 410. CNS involvement and abnormalities:
  • •a. Any CNS tumor mass and/or parameningeal mass (cranial and/or spinal) by imaging with current or prior history of neurologic symptoms within 3 months prior to screening (for France, refer to Appendix 8 for details).
  • •Note: CNS-3 involvement without neurologic symptoms will be allowed.
  • •b. History or presence of any CNS disorder such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema with confirmed structural defects not related to lymphoma by appropriate imaging. History of stroke or transient ischemic attack within 12 months before enrollment. Patients with seizure disorders requiring active anti-convulsive medication.
  • •208. and 416. Any medical condition likely to interfere with assessment of the safety or efficacy of study treatment
  • •209. and 414. Primary immunodeficiency
  • •210. and 407. History of HIV infection or acute /chronic active hepatitis B or C infection. Subjects with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines

Investigators

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