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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 : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Rebecca Gardner, Seattle Children's Hospital

Tracking Information
First Submitted Date  ICMJE September 2, 2020
First Posted Date  ICMJE September 30, 2020
Last Update Posted Date January 19, 2023
Actual Study Start Date  ICMJE September 25, 2020
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • 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
  • The ability to successfully manufacture SCRI-CAR22v2 [ Time Frame: 28 days ]
    We will measure the number of successfully manufactured SCRI-CAR22v2 products
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Lymphoma
Intervention  ICMJE Biological: SCRI-CAR22v2
Single infusion of SCRI-CAR22v2
Study Arms  ICMJE Experimental: SCRI-CAR22v2
Patients will receive SCRI-CAR22v2 in either Phase I or Phase II
Intervention: Biological: SCRI-CAR22v2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 25, 2020)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2038
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Corinne Summers, MD 206-987-2106 CBDCIntake@seattlechildrens.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04571138
Other Study ID Numbers  ICMJE PLAT-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rebecca Gardner, Seattle Children's Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Seattle Children's Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Corinne Summers, MD Seattle Children's Hospital
PRS Account Seattle Children's Hospital
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP