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Active Not Recruiting
NCT03186118
Pilot Study of T-APCs Following CAR T Cell Immunotherapy for CD19+ Leukemia
Conditions: CD 19+ Acute Leukemia
Sex: All
Ages: 1 Year – 30 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: Seattle Children's Hospital
Location: Seattle Children's Hospital Seattle Washington
Summary
Patients with relapsed or refractory CD 19+ leukemia who have achieved remission after CD19 CAR-T cell treatment sometimes relapse because the CD 19 CAR-T cells decrease in number over time. Study PLAT-03 will test whether administering T cell antigen presenting cells (T-APCs) at intervals following treatment with CAR-T cells improves CD 19 CAR-T cell persistence and reduces the incidence of leukemia relapse.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of recurrent or refractory CD19+ leukemia
* Adequate performance status
* Able to tolerate apheresis, including placement of temporary apheresis line if required
* Adequate renal, liver, cardiac, and respiratory function
* Adequate absolute lymphocyte count
* HIV negative; Hepatitis B and C negative within 3 months prior to enrollment.
Exclusion Criteria:
* Evidence of active clinically significant CNS dysfunction
* Evidence of active malignancy other than CD19+ malignancy
* Evidence of active GVHD, or on immunosuppressive GVHD therapy within 4 weeks prior to enrollment
Source: ClinicalTrials.gov (NCT03186118). StuddyBuddy aggregates publicly available trial information.