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NCT03126864 · ClinicalTrials.gov registry record · Phase 1
Study of Adoptive Cellular Therapy Using Autologous T Cells Transduced With Lentivirus to Express a CD33 Specific Chimeric Antigen Receptor in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03126864: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03126864 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03126864, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
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 about the safety and tolerability of 3 different doses of CD33-CAR-T cells (referred to throughout the consent as "T-cells") in patients who have CD33-positive acute myeloid leukemia (AML) that is relapsed (has come back) or refractory (has not responded to treatment). CD33-CAR-T is made by genetically modifying (changing) your T-cells (a type of white blood cell). T-cells are genetically changed to help target leukemia cells. This is an investigational study. CD33-CAR-T is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 39 participants will be enrolled in this study. All will take part at MD Anderson.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- PROCEDURE Leukapheresis
- BIOLOGICAL CD33-CAR-T Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-08-04 |
| Est. Completion | 2019-10-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03126864
The ClinicalTrials.gov registry entry for NCT03126864 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 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 4 interventions - of which Cyclophosphamide is the first listed.
NCT03126864 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03126864 about?
NCT03126864 is a clinical study titled "Study of Adoptive Cellular Therapy Using Autologous T Cells Transduced With Lentivirus to Express a CD33 Specific Chimeric Antigen Receptor in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia". 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 about the safety and tolerability of 3 different doses of CD33-CAR-T cells (referred to throughout the consent as "T-cells") in patients who...
What is the current status of trial NCT03126864?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2017-08-04. Estimated completion is 2019-10-10.
What interventions are being tested in trial NCT03126864?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Leukapheresis (PROCEDURE), CD33-CAR-T Cell Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT03126864?
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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