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HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML

StatusRecruiting
PhasePhase 1
Started2024-11-19
View on ClinicalTrials.gov ↗

Amendment history

2026-07-13
2 amendments v6-v7
2 re-verifications since 2026-07-02, no change to tracked fields
2025-06-27
Study Status, Eligibility v5
Eligibility criteria+436 characters
Inclusion Criteria: Diagnosis of a high risk myelodysplastic syndromes (MDS), treatment related MDS, OR relapsed/refractory acute myelogenous leukemia (AML). Absolute lymphocyte count (ALC) ≥ 200 cells/µL OR absolute c [...] continued for the 1st two weeks of Cycle 1 to maintain it. Karnofsky performance status ≥ 70% Adequate organ function within 14 days (30 days for cardiac) [...] prior to the performance of any research related activity. Pulmonary: room air 0 2 saturation at ≥ 95% Exclusion Criteria: Pregnant or breast-feeding. The effect o [...] mixed lineage leukemia. Acute promyelocytic leukemia (APL). No [...] [...]
2025-02-06
Study Status, Study Design v4
Re-verified, no change to tracked fields
2025-01-31
Study Status, Study Design v3
Primary completion date2028-11-07→2027-03-30
Completion date2029-11-07→2027-10-30
2024-11-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-01-01→confirmed 2024-11-19
Study sites0→1
2024-11-04
Study Status v1
Start date2024-10-01→2025-01-01
2024-09-10
Original filing
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
Trial Details
NCT Number NCT06594445
Lead Sponsor Masonic Cancer Center, University of Minnesota
Conditions Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes
Enrollment 45 participants
Start Date 2024-11-19
Primary Completion 2027-03-30 (estimated)
Study Completion 2027-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-14