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NCT02028455 · ClinicalTrials.gov registry record · Phase 1
A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia
A Phase 1 study of CD19+ Acute Leukemia, sponsored by Seattle Children's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 167
- Enrollment target
- 3
- Study locations
NCT02028455 is a Phase 1 study of CD19+ Acute Leukemia that is active but no longer recruiting, run by Seattle Children's Hospital. The registered enrollment target is 167 participants. The trial reports 3 study locations across 2 states.
The verdict
NCT02028455, a Phase 1 study of CD19+ Acute Leukemia, is active but no longer recruiting, sponsored by Seattle Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 167 participants
- Enrollment target
- 3
- Study locations
Study Summary
Patients with relapsed or refractory leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia. This is a phase 1/2 study designed to determine the maximum tolerated dose of the CAR+ T cells as well as to determine the efficacy. The phase 1 cohort is restricted to those patients who have already had an allogeneic hematopoietic cell transplant (HCT). The phase 2 is open to all patients regardless of having a history of HCT.
Conditions Studied
Interventions
- BIOLOGICAL Patient Derived CD19 specific CAR T cells also expressing an EGFRt
Study Locations (3)
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital Oakland - Oakland
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2014-02-11 |
| Est. Completion | 2036-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02028455
The ClinicalTrials.gov registry entry for NCT02028455 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 167 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with CD19+ Acute Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Patient Derived CD19 specific CAR T cells also expressing an EGFRt is the first listed.
NCT02028455 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, Washington.
Frequently Asked Questions
What is clinical trial NCT02028455 about?
NCT02028455 is a clinical study titled "A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia". Patients with relapsed or refractory leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T cell to recognize and ki...
What is the current status of trial NCT02028455?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 167 participants. The study started on 2014-02-11. Estimated completion is 2036-07.
What conditions does trial NCT02028455 study?
This clinical trial studies the following conditions: CD19+ Acute Leukemia.
What interventions are being tested in trial NCT02028455?
The interventions under investigation include: Patient Derived CD19 specific CAR T cells also expressing an EGFRt (BIOLOGICAL).
Who is sponsoring clinical trial NCT02028455?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02028455 being conducted?
This trial has 3 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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