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ACTIVE NOT RECRUITING Phase 1

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

NCT03330691 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

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

FieldValue
Enrollment Target 78 participants
Start Date 2017-11-03
Est. Completion 2035-03-03
Phase Phase 1

Sponsor

Seattle Children's Hospital

127 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03330691

The ClinicalTrials.gov registry entry for NCT03330691 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 78 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 127 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03330691 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, District of Columbia, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03330691?

The interventions under investigation include: Patient-derived CD19- and CD22 specific CAR (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03330691?

This trial is sponsored by Seattle Children's Hospital, which has 127 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial