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NCT03330691 · ClinicalTrials.gov registry record · Phase 1
A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia
A Phase 1 study of Lymphoma and Leukemia, sponsored by Seattle Children's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
- 5
- Study locations
NCT03330691: Active Phase 1 study of Lymphoma and Leukemia, sponsored by Seattle Children's Hospital.
NCT03330691 is a Phase 1 study of Lymphoma and Leukemia that is active but no longer recruiting, run by Seattle Children's Hospital. The registered enrollment target is 78 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (84% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03330691, a Phase 1 study of Lymphoma and Leukemia, is active but no longer recruiting, sponsored by Seattle Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Type, frequency, severity, and duration of adverse events will be summarized
Interventions
- BIOLOGICAL Patient-derived CD19- and CD22 specific CAR
Study Locations (5)
California
- Children's Hospital Los Angeles - Los Angeles
District of Columbia
- Children's National Medical Center - Washington D.C.
Indiana
- Riley Hospital for Children - Indianapolis
Washington
- Seattle Children's Hospital - Seattle
British Columbia
- Children's and Women's Health Centre of British Columbia - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2017-11-03 |
| Est. Completion | 2035-03-03 |
| Phase | Phase 1 |
What the registry record for NCT03330691 still lists
NCT03330691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Patient-derived CD19- and CD22 specific CAR is the first listed.
NCT03330691 lists 5 locations in 5 states (California, District of Columbia, Indiana).
Frequently Asked Questions
What is clinical trial NCT03330691 about?
NCT03330691 is a clinical study titled "A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia". 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 ...
What is the current status of trial NCT03330691?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2017-11-03. Estimated completion is 2035-03-03.
What conditions does trial NCT03330691 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia.
What interventions are being tested in trial NCT03330691?
The interventions under investigation include: Patient-derived CD19- and CD22 specific CAR (BIOLOGICAL).
Who is sponsoring clinical trial NCT03330691?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03330691 being conducted?
This trial has 5 study locations across California, District of Columbia, Indiana, Washington, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03330691's enrollment target sits among peer trials
78 106th of 299 higher than 191 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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