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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). 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.
Primary Outcome
RP2D defined as the highest dose level in which 6 patients have been treated with at most 1 instance of dose limiting toxicity (DLT). DLT is defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and occurring during the first course on study that meets any of the following criteria: * CTCAE grades non-reversible grade 3, or any grade 4-5 allergic reactions related to the stud
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 |
Why NCT03126864 stopped before completion
NCT03126864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03126864 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03126864's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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