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CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684889
Recruitment Status : Active, not recruiting
First Posted : September 26, 2018
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Rebecca Gardner, Seattle Children's Hospital

Brief Summary:
Patients with relapsed or refractory leukemia or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically engineered to express a fully human chimeric antigen receptor (CAR). The CAR used in this study can recognize CD19, a protein expressed on the surface of leukemia and lymphoma cells. The fully human CAR used in this study may help protect against rejection of the CAR T cells, which in turn could lead to lasting protection against return of the leukemia or lymphoma. The phase 1 part of this study will determine the safety of these CAR T cells, and the phase 2 part of the study will determine how effective this CAR T cell therapy is. Both patients who have never had prior CAR T cell therapy and those who have had prior CAR T cell therapy may be eligible to participate in this study.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: SCRI-huCAR19v1 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-06: A Phase 1/2 Study of CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arm Intervention/treatment
Experimental: SCRI-huCAR19v1
Patients will receive SCRI-huCAR19v1 in either Phase I or Phase II
Biological: SCRI-huCAR19v1
1:1 mixture of CD4:CD8 autologous T cells lentivirally transduced to express a second generation 4-1BB-ζ human CD19-specific CAR and Her2tG




Primary Outcome Measures :
  1. The adverse events associated with CAR T cell product infusions will be assessed [ Time Frame: 30 days ]
    The type, frequency, severity, and duration of adverse events will be summarized

  2. The leukemia response to SCRI-huCAR19v1 in subjects with relapsed or refractory CD19+ leukemia will be assessed [ Time Frame: 63 days ]
    Response will be defined by standard bone marrow assessment and standard response criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects age ≥ 1 and ≤ 28 years
  • First 2 enrolled subjects: age ≥ 18 and ≤ 28 years
  • Evidence of refractory or recurrent CD19+ leukemia or lymphoma
  • Able to tolerate apheresis, or has sufficient existing apheresis product or T cells for manufacturing investigational product
  • Life expectancy ≥ 8 weeks
  • Lansky or Karnofsky, as applicable, score ≥ 50
  • Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy, if the subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of CAR T cells
  • ≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy
  • No prior virotherapy
  • ≥ 7 days post last corticosteroid therapy
  • ≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use
  • ≥ 1 day post hydroxyurea
  • 30 days post most recent CAR T cell infusion
  • Adequate organ function
  • Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL
  • Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial
  • Subject and/or legally authorized representative has signed the informed consent form for this study

Exclusion Criteria:

  • Presence of active malignancy other than disease under study
  • History of symptomatic CNS pathology or ongoing symptomatic CNS pathology
  • CNS involvement of leukemia or lymphoma that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and CAR T cell infusion
  • Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
  • Presence of active severe infection
  • Presence of primary immunodeficiency syndrome
  • Subject has received prior virotherapy
  • Pregnant or breastfeeding
  • Subject and/or legally authorized representative unwilling to provide consent/assent for participation in the 15-year follow up period, required if CAR T cell therapy is administered
  • Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684889


Locations
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United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
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Study Chair: Colleen Annesley, MD Seattle Children's Hospital
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Responsible Party: Rebecca Gardner, Associate Medical Director, Immunotherapy Coordinating Center, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03684889    
Other Study ID Numbers: PLAT-06
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecca Gardner, Seattle Children's Hospital:
CAR T cell, CD19, pediatric, young adults
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases