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NCT06594445 · ClinicalTrials.gov registry record · Phase 1
HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Masonic Cancer Center, University of Minnesota.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT06594445: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Masonic Cancer Center, University of Minnesota.
NCT06594445 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 45 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06594445, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Masonic Cancer Center, University of Minnesota.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I dose finding study of GTB-3650 (anti-CD16/IL-15/anti-CD33) Tri-Specific Killer Engager (TriKE®) for the treatment of select CD33-expressing refractory/relapsed myeloid malignancies in adults ≥ 18 years of age who are not a candidate for potentially curative therapy, including hematopoietic stem cell transplantation, and are refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit. The hypothesis is GTB-3650 TriKE will induce natural killer (NK) cell function by targeting malignant cells, as well as, CD33+ myeloid derived suppressor cells (MDSC) which contribute to a tumor induced immunosuppression. Because CD16 is the most potent activating receptor on NK cells, this single agent may induce a targeted antiCD33+ tumor response
Primary Outcome
Maximum tolerated dose (MTD) of GTB-3650 TriKE defined as the dose level that most closely corresponds to the target dose limiting toxicity (DLT) proportion of 20% or less.
Conditions Studied
Interventions
- DRUG GTB-360
Study Locations (1)
Minnesota
- Masonic Cancer Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2024-11-19 |
| Est. Completion | 2027-10-30 |
| Phase | Phase 1 |
What NCT06594445 shows while recruiting
NCT06594445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (61% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which GTB-360 is the first listed.
NCT06594445 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06594445 about?
NCT06594445 is a clinical study titled "HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML". This is a Phase I dose finding study of GTB-3650 (anti-CD16/IL-15/anti-CD33) Tri-Specific Killer Engager (TriKE®) for the treatment of select CD33-expressing refractory/relapsed myeloid malignancies in adults ≥ 18 years of age who are not a candidate for potentially curative therapy, including hemat...
What is the current status of trial NCT06594445?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2024-11-19. Estimated completion is 2027-10-30.
What conditions does trial NCT06594445 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloid Malignancy.
What interventions are being tested in trial NCT06594445?
The interventions under investigation include: GTB-360 (DRUG).
Who is sponsoring clinical trial NCT06594445?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06594445 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06594445's enrollment target sits among peer trials
45 158th of 306 higher than 145 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
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