Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies
NCT02315612 · View on ClinicalTrials.gov ↗
Study Summary
Background: \- One type of cancer therapy takes blood cells from a person, changes them in a lab, then gives the cells back to the person. In this study, researchers are using an anti-CD22 gene, a virus, and an immune receptor to change the cells. Objective: \- To see if giving anti-CD22 Chimeric Antigen Receptor (CAR) cells to young people with certain cancers is safe and effective. Eligibility: \- People ages 1-39 with a leukemia or lymphoma that has not been cured by standard therapy. Design: * Participants will be screened to ensure their cancer cells express the CD22 protein. They will also have medical history, physical exam, blood and urine tests, heart tests, scans, and x-rays. They may give spinal fluid or have bone marrow tests. * Participants may have eye and neurologic exams. * Participants will get a central venous catheter or a catheter in a large vein. * Participants will have white blood cells removed. Blood is removed through a needle in an arm. White blood cells are removed. The rest of the blood is returned by needle in the other arm. * The cells will be changed in a laboratory. * Participants will get two IV chemotherapy drugs over 4 days. Some will stay in the hospital for this. * All participants will be in the hospital to get anti-CD22 CAR cells through IV. They will stay until any bad side effects are gone. * Participants will have many blood tests. They may repeat some screening exams. * Participants will have monthly visits for 2-3 months, then every 3-6 months. They may repeat some screening exams. * Participants will have follow-up for 15 years.
Conditions Studied
Interventions
- BIOLOGICAL CD22-CAR
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2014-12-12 |
| Est. Completion | 2024-10-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02315612
The ClinicalTrials.gov registry entry for NCT02315612 describes a study currently listed as completed. 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 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention — of which CD22-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: NCT02315612 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. 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 NCT02315612 about?
NCT02315612 is a clinical study titled "Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies". Background: \- One type of cancer therapy takes blood cells from a person, changes them in a lab, then gives the cells back to the person. In this study, researchers are using an anti-CD22 gene, a virus, and an immune receptor to change the cells. Objective: \- To see if giving anti-CD22 Chimeric...
What is the current status of trial NCT02315612?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2014-12-12. Estimated completion is 2024-10-29.
What conditions does trial NCT02315612 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Follicular Lymphoma, Acute Lymphocytic Leukemia, ALL, NHL. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02315612?
The interventions under investigation include: CD22-CAR (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02315612?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02315612 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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