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Minor2 versionsRe-verified since Oct 31, 2024, no change to tracked fieldsv17-v18
MinorTrial status: Recruiting to Active, Not Recruiting
Enrollment target: estimated 80 to confirmed 78
Primary completion date changed from estimate of Sep 15, 2023 to Sep 13, 2023
Site details revised at 5 of 5 sites
v16
MinorPrimary completion date: Jun 15, 2023 to Sep 15, 2023
Site contacts updated at 1 of 5 sites
v15
NotablePrimary completion date: Dec 15, 2022 to Jun 15, 2023v14
MinorSite contacts updated at 2 of 5 sitesv13
Show 11 earlier versionsHide 11 earlier versions
NotablePrimary completion date: Mar 15, 2022 to Dec 15, 2022
Enrollment target: 60 to 80
Study completion date: Nov 3, 2034 to Mar 3, 2035
Site details revised at 1 of 5 sites
v12
MinorEnrollment target: 46 to 60
Site details revised at 1 of 5 sites
v11
MinorStudy sites: 3 to 5v10
NotableTrial status: Active, Not Recruiting to Recruitingv9Show 5 more changesShow less
Primary completion date: Nov 3, 2020 to Mar 15, 2022
Enrollment target: 33 to 46
Eligibility criteria shortened, about 10 words
Site details revised at 3 of 3 sites
Study arms: 1 to 2
NotablePrimary completion date: Nov 3, 2019 to Nov 3, 2020
Trial status: Recruiting to Active, Not Recruiting
Site details revised at 3 of 3 sites
v8
MinorStudy sites: 2 to 3v7
MinorStudy sites: 1 to 2v6
MinorEligibility criteria expanded, about 116 words
Site contact updated
Study title shortened, about 2 words
v5
MinorRe-verified, no change to tracked fieldsv4
NotableTrial status: Not Yet Recruiting to Recruitingv3Show 4 more changesShow less
Study sites: 0 to 1
Primary completion date: Nov 15, 2019 to Nov 3, 2019
Study completion date: Nov 15, 2034 to Nov 3, 2034
Start date changed from estimate of Nov 15, 2017 to Nov 3, 2017
MinorInterventions: Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt (Biological) to Patient-derived CD19- and CD22 specific CAR (Biological)v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express two chimeric antigen receptors (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.