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ACTIVE NOT RECRUITING
NCT03330691
PHASE1

A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia

Sponsor: Seattle Children's Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-05: A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia

Key Details

Gender

All

Age Range

Any - 30 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2017-11-03

Completion Date

2035-03-03

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

Patient-derived CD19- and CD22 specific CAR

Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt

Locations (5)

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Seattle Children's Hospital

Seattle, Washington, United States

Children's and Women's Health Centre of British Columbia

Vancouver, British Columbia, Canada