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NCT04714372 · ClinicalTrials.gov registry record · Phase 1
FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT04714372: Completed Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT04714372 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04714372, a Phase 1 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This Phase I open-label dose escalation study is conducted in two stages with a primary endpoint to identify the maximum tolerated dose (MTD) of FT538 when administered with daratumumab in patients 12 years and older with advanced acute myeloid leukemia (AML) and related myeloid diseases.
Primary Outcome
Dose limiting toxicity (DLT) is defined as any AE (based on CTCAE v5) that is at least possibly related to FT538 that occurs after the first FT538 infusion through the end of the DLT assessment period on Day 29 as defined below: Any Grade 4 non-hematologic AE, Grade 3 pulmonary or cardiac AE of any duration, Grade 3 immune cell associated neurotoxicity syndrome (ICANS) of any duration, Any other Grade 3 non-hematologic AE of \>72 hours duration or Grade ≥2 acute GvHD requiring systemic steroid
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Daratumumab/rHuPH20
- DRUG FT538
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2024-10-15 |
| Phase | Phase 1 |
What the finished NCT04714372 record still lists
NCT04714372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04714372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04714372 about?
NCT04714372 is a clinical study titled "FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia". This Phase I open-label dose escalation study is conducted in two stages with a primary endpoint to identify the maximum tolerated dose (MTD) of FT538 when administered with daratumumab in patients 12 years and older with advanced acute myeloid leukemia (AML) and related myeloid diseases.
What is the current status of trial NCT04714372?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2021-11-03. Estimated completion is 2024-10-15.
What interventions are being tested in trial NCT04714372?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Daratumumab/rHuPH20 (DRUG), FT538 (DRUG).
Who is sponsoring clinical trial NCT04714372?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04714372's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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