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NCT02494167 · ClinicalTrials.gov registry record · Phase 1
Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM)
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 2
- Study locations
NCT02494167 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 44 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (62% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT02494167, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research study uses special blood cells called multiple tumor-associated antigen (TAA)-specific T cells (a new experimental therapy) to treat patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) which has come back, or may come back, or has not gone away after standard treatment, including an allogeneic hematopoietic stem cell transplant (HSCT). The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin lymphomas that are infected with Epstein-Barr virus (EBV). EBV is found in cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape being killed. The investigators previously tested whether special white blood cells (called T cells) that were trained to kill EBV-infected cells could affect these tumors, and in many patients the investigators found that giving these trained T cells causes a complete or partial response. Other cancers express specific proteins that can be targeted in the same way. The investigators have been able to infuse such tumor-targeted cells into up to 10 patients with lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment appears to be safe. Therefore, the investigators now want to test whether the investigators can direct these special T cells against other types of cancers that carry similar proteins called tumor-associated antigens (TAAs). These proteins are specific to the cancer cell, so they either do not show up, or show up in low quantities, or normal human cells. The investigators will grow T cells from patients' stem cell donors in the laboratory in a way that will train them to recognize the tumor proteins WT1, NY-ESO-1, PRAME, and Survivin, which are expressed on most AML and MDS cancer cells. The cells will be infused at least 30 days post-allogeneic stem cell
Conditions Studied
Interventions
- BIOLOGICAL MultiTAA-specific T cells
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2016-02 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02494167
The ClinicalTrials.gov registry entry for NCT02494167 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (62% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which MultiTAA-specific T cells is the first listed.
NCT02494167 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02494167 about?
NCT02494167 is a clinical study titled "Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM)". This research study uses special blood cells called multiple tumor-associated antigen (TAA)-specific T cells (a new experimental therapy) to treat patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) which has come back, or may come back, or has not gone away after standard t...
What is the current status of trial NCT02494167?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2016-02. Estimated completion is 2027-02.
What conditions does trial NCT02494167 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.
What interventions are being tested in trial NCT02494167?
The interventions under investigation include: MultiTAA-specific T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02494167?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02494167 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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