Clinical Trials /

A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma

NCT04571138

Description:

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.

Related Conditions:
  • Leukemia
  • Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: PLAT-07
  • NCT ID: NCT04571138

Conditions

  • Leukemia
  • Lymphoma

Interventions

DrugSynonymsArms
SCRI-CAR22v2SCRI-CAR22v2

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
SCRI-CAR22v2ExperimentalPatients will receive SCRI-CAR22v2 in either Phase I or Phase II
  • SCRI-CAR22v2

Eligibility 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
      
Maximum Eligible Age:30 Years
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:he adverse events associated with CAR T cell product infusions will be assessed
Time Frame:28 days post-infusion
Safety Issue:
Description:The type, frequency, severity, and duration of adverse events will be summarized

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seattle Children's Hospital

Last Updated

October 6, 2020