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NCT03927261 · ClinicalTrials.gov registry record · Phase 1
PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Precigen.
- Active
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
- 2
- Study locations
NCT03927261 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is active but no longer recruiting, run by Precigen. The registered enrollment target is 88 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (24% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT03927261, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Precigen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a first-in-human dose escalation/dose expansion study to evaluate the safety and identify the best dose of modified immune cells, PRGN-3006 (autologous chimeric antigen receptor (CAR) T cells), in adult patients with relapsed or refractory acute myeloid leukemia (AML), Minimal Residual Disease (MRD) positive acute myeloid leukemia or higher risk myelodysplastic syndrome (MDS). Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.
Conditions Studied
Interventions
- DRUG PRGN-3006 T Cells
Study Locations (2)
Florida
- H Lee Moffitt Cancer Center and Research Institute - Tampa
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2019-05-20 |
| Est. Completion | 2025-08-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03927261
The ClinicalTrials.gov registry entry for NCT03927261 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 88 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 (24% lower). The listed sponsor is Precigen, which has 5 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 PRGN-3006 T Cells is the first listed.
NCT03927261 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03927261 about?
NCT03927261 is a clinical study titled "PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS". This is a first-in-human dose escalation/dose expansion study to evaluate the safety and identify the best dose of modified immune cells, PRGN-3006 (autologous chimeric antigen receptor (CAR) T cells), in adult patients with relapsed or refractory acute myeloid leukemia (AML), Minimal Residual Disea...
What is the current status of trial NCT03927261?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2019-05-20. Estimated completion is 2025-08-01.
What conditions does trial NCT03927261 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes.
What interventions are being tested in trial NCT03927261?
The interventions under investigation include: PRGN-3006 T Cells (DRUG).
Who is sponsoring clinical trial NCT03927261?
This trial is sponsored by Precigen, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03927261 being conducted?
This trial has 2 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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