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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 CD 19+ Acute Leukemia, sponsored by Seattle Children's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 167
- Enrollment target
- 3
- Study locations
NCT02028455: Active Phase 1 study of CD 19+ Acute Leukemia, sponsored by Seattle Children's Hospital.
NCT02028455 is a Phase 1 study of CD 19+ Acute Leukemia that is active but no longer recruiting, run by Seattle Children's Hospital. The registered enrollment target is 167 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (178% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02028455, a Phase 1 study of CD 19+ 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.
Primary Outcome
The safety of the T cell infusion at the maximum tolerated dose determined in Phase 1, and further characterized in Phase 2, will be described
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 |
What the registry record for NCT02028455 still lists
NCT02028455 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (178% higher).
The record links to 1 condition, with CD 19+ 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 a single indexed study location in 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: CD 19+ 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.
Learn More About Clinical Trials
Similar trials for CD 19+ Acute Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02028455's enrollment target sits among peer trials
167 330th of 2000 higher than 1,671 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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