Pilot Study of T-APCs Following CAR T Cell Immunotherapy for CD19+ Leukemia

Plain-language summary

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.

Trial details

Phase

Phase 1

Status

Active, not recruiting

Sponsor

Seattle Children's Hospital

Intervention

T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC) (CD19+ Chimeric Antigen Receptor T-cells (CAR-T cells))

Start date

8/4/2017

Estimated completion

7/1/2033

Countries

United States

Related genes

Locations

• Seattle, United States

Eligibility criteria

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