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A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571138
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : October 8, 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 chimeric antigen receptor (CAR). The CAR used in this study can recognize CD22, a protein expressed on the surface of leukemia and lymphoma cells. The phase 1 part of this study will determine the safety and appropriate dose level 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-CAR22v2 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 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)-07: A Phase 1/2 Study of CD22-Specific CAR T Cells for CD22+ Leukemia or Lymphoma
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : February 2038

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arm Intervention/treatment
Experimental: SCRI-CAR22v2
Patients will receive SCRI-CAR22v2 in either Phase I or Phase II
Biological: SCRI-CAR22v2
Single infusion of SCRI-CAR22v2




Primary Outcome Measures :
  1. he adverse events associated with CAR T cell product infusions will be assessed [ Time Frame: 28 days post-infusion ]
    The type, frequency, severity, and duration of adverse events will be summarized

  2. The ability to successfully manufacture SCRI-CAR22v2 [ Time Frame: 28 days ]
    We will measure the number of successfully manufactured SCRI-CAR22v2 products

  3. The leukemia response to SCRI-CAR22v2 in subjects with relapsed or refractory CD22+ leukemia will be assessed [ Time Frame: 28 days post-infusion ]
    The efficacy of the T cell infusion will be estimated based on the number of participants who have an MRD negative bone marrow aspirate following the T cell infusion



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged ≤ 30 years. First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
  • Evidence of refractory or recurrent CD22+ leukemia or lymphoma
  • Able to tolerate apheresis, or subject with 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
  • ≥ 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
  • Subjects with uniform expression of CD19 on their malignant cells who are eligible but have not attempted CD19 directed CAR T cell therapy
  • For subjects having had a previous stem cell transplant: 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 subject 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): NCT04571138


Contacts
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Contact: Corinne Summers, MD 206-987-2106 CBDCIntake@seattlechildrens.org

Locations
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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Corinne Summers, MD    206-987-2106    CBDCIntake@seattlechildrens.org   
Principal Investigator: Corinne Summers, MD         
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
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Study Chair: Corinne Summers, 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: NCT04571138    
Other Study ID Numbers: PLAT-07
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases