A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma
J
Jodi Skiles
Primary Investigator
Overview
Patients with relapsed or refractory leukemia or lymphoma are often refractory to furtherhemotherapy. In this study, the investigators will attempt to use T cells obtained directlyhe 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 ofukemia and lymphoma cells. The phase 1 part of this study will determine the safety anddose 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 cellherapy and those who have had prior CAR T cell therapy may be eligible to participate inhis study.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Leukemia, Lymphoma
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Age: - 30 Years
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Gender: All
Inclusion Criteria:
- Male and female subjects aged ≤ 30 years. First 2 enrolled subjects: age ≥ 18 and ≤ 30years
- Evidence of refractory or recurrent CD22+ leukemia or lymphoma
- Able to tolerate apheresis, or subject with sufficient existing apheresis product or Tufacturing investigational product.
- Life expectancy ≥ 8 weeks
- Lansky or Karnofsky, as applicable, score ≥ 50
- Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, anddiotherapy, if the subject does not have a previously obtained apheresis producthat is acceptable and available for manufacturing of CAR T cells
- ≥ 7 days post last chemotherapy and biologic therapy, with the exception ofhecal 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 highlyve contraception from consent through 12 months following infusion ofvestigational product on trial
- Subject and/or legally authorized representative has signed the informed consent formhis 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 thevestigator, cannot be controlled during the interval between enrollment and CAR Tusion
- Subjects with uniform expression of CD19 on their malignant cells who are eligible buthave not attempted CD19 directed CAR T cell therapy
- For subjects having had a previous stem cell transplant: presence of active GVHD, orving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks
- 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/assenthe 15-year follow-up period, required if CAR T cell therapy isdministered
- Presence of any condition that, in the opinion of the investigator, would prohibit theubject from undergoing treatment under this protocol
Updated on
28 Apr 2024.
Study ID: PLAT-07
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