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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03186118). StuddyBuddy aggregates publicly available trial information.