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NCT03056339 · ClinicalTrials.gov registry record · Phase 1
Umbilical & Cord Blood (CB) Derived CAR-Engineered NK Cells for B Lymphoid Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT03056339: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03056339 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 49 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03056339, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if giving genetically changed immune cells, called CAR-NK cells, after chemotherapy will improve the disease in stem cell transplant patients with relapsed (has returned) and/or refractory (has not responded to treatment) B-cell lymphoma or leukemia. Also, researchers want to find the highest tolerable dose of CAR-NK cells to give to patients with relapsed or refractory B-cell lymphoma or leukemia. The safety of this treatment will also be studied. This is an investigational study. The making of and infusion of genetically changed NK cells and the drug AP1903 (if you receive it, explained below) are not FDA approved or commercially available for use in this type of disease. They are currently being used for research purposes only. The chemotherapy drugs in this study (fludarabine, cyclophosphamide, and mesna) are commercially available and FDA approved. Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Mesna
- DRUG AP1903
- BIOLOGICAL iC9/CAR.19/IL15-Transduced CB-NK Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2017-06-21 |
| Est. Completion | 2023-03-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03056339
The ClinicalTrials.gov registry entry for NCT03056339 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03056339 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03056339 about?
NCT03056339 is a clinical study titled "Umbilical & Cord Blood (CB) Derived CAR-Engineered NK Cells for B Lymphoid Malignancies". If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if giving genetically changed immune cells, call...
What is the current status of trial NCT03056339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2017-06-21. Estimated completion is 2023-03-06.
What interventions are being tested in trial NCT03056339?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), AP1903 (DRUG), iC9/CAR.19/IL15-Transduced CB-NK Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03056339?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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