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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: Active Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Precigen.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of dose limiting toxicity (DLT) as defined in the protocol
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 |
What the registry record for NCT03927261 still lists
NCT03927261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (24% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03927261's enrollment target sits among peer trials
88 90th of 306 higher than 217 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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