PLAT-03 is a Phase 1 study addressing relapse in patients with relapsed or refractory CD19+ leukemia who achieved remission after CD19 CAR-T cell treatment but whose CAR-T cells decrease in number over time. It tests whether administering T cell antigen presenting cells (T-APCs) at intervals after CAR-T therapy improves CD19 CAR-T cell persistence and reduces leukemia relapse. Eligibility requires recurrent or refractory CD19+ leukemia, adequate performance status, ability to tolerate apheresis, adequate renal, liver, cardiac and respiratory function, an adequate absolute lymphocyte count, and HIV negativity.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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