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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


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.

Trial Eligibility

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

Study Info

Organization

Seattle Children's Hospital


Primary Outcome

he adverse events associated with CAR T cell product infusions will be assessed


Outcome Timeframe 28 days post-infusion

NCTID NCT04571138

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2020-09-25

Completion Date 2025-06

Enrollment Target 42

Interventions

BIOLOGICAL SCRI-CAR22v2

Locations Recruiting

Children's Hospital Los Angeles

United States, California, Los Angeles


Children's National Hospital

United States, District of Columbia, Washington


Riley Hospital for Children

United States, Indiana, Indianapolis


Texas Children's Hospital

United States, Texas, Houston


Seattle Children's Hospital

United States, Washington, Seattle


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