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

  • STATUS
    Recruiting
  • End date
    Feb 21, 2038
  • participants needed
    42
  • sponsor
    Seattle Children's Hospital
Updated on 21 April 2022
tyrosine
lymphoma
hydroxyurea
leukemia
intrathecal chemotherapy
chemotherapy regimen
refractory leukemia
lymphoma cells

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.

Details
Condition Leukemia, Lymphoma
Treatment SCRI-CAR22v2
Clinical Study IdentifierNCT04571138
SponsorSeattle Children's Hospital
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

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
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
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