Actively Recruiting
HM2023-05: GTB-3650 Tri-Specific Killer Engager for Treatment of High Risk Myelodysplastic Syndromes and Relapsed/Refractory Acute Myeloid Leukemia
Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-06-29
45
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating GTB-3650, a Tri-Specific Killer Engager (TriKE®), in adults aged 18 and older with select CD33-expressing refractory or relapsed myeloid malignancies who are not candidates for curative therapies such as stem cell transplantation. This Phase I study aims to find the appropriate dose of GTB-3650, which is designed to activate natural killer (NK) cells to target malignant cells and certain immune-suppressing cells in these blood cancers. GTB-3650 is given as a continuous infusion during an inpatient stay, with each treatment cycle lasting 28 days and consisting of two 72-hour infusion periods called "blocks" followed by about 18 days without treatment. Patients may receive up to four cycles, with doses increasing across seven levels from 1.25 to 100 micrograms per kilogram per day. Safety criteria must be met before starting each infusion block, and treatment continues only if disease response and eligibility criteria are satisfied. Participants will stay in the hospital during infusions and be closely monitored for safety and response. Researchers will assess the highest tolerated dose, adverse events, event-free survival, and overall survival over six months. The study includes laboratory tests, physical exams, and monitoring of immune cell counts. Participants will be followed through the treatment cycles to evaluate the effects and safety of GTB-3650.
CONDITIONS
Brief Title
HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of high risk myelodysplastic syndromes (MDS), treatment-related MDS, or relapsed/refractory acute myeloid leukemia (AML)
- Absolute lymphocyte count of at least 200 cells/µL or NK cell count over 25 cells/µL within 14 days before treatment
- Peripheral blasts count less than or equal to 20,000 at treatment start
- Karnofsky performance status of 70% or higher
- Adequate organ function within 14 days (30 days for cardiac) before treatment
- Agreement to use effective contraception during treatment and for 4 months after
- Agreement to stay within 60 minutes of the study center through the first 29 days of treatment
- Voluntary written consent before any research activities
- Pulmonary oxygen saturation of at least 95% on room air
You will not qualify if you...
- Pregnant or breastfeeding individuals
- Candidates for hematopoietic stem cell transplant or newly relapsed after transplant
- Diagnosis of bi-phenotypic acute leukemia, mixed lineage leukemia, or acute promyelocytic leukemia
- Recent anticancer therapy within 14 days before treatment or unresolved side effects
- New or worsening lung infiltrates unless stable after treatment
- Active systemic infections needing intravenous antibiotics
- Known HIV infection
- Active hepatitis B or C virus detectable by PCR
- Positive tests for chronic hepatitis B or C
- Prior malignancy except certain treated skin or cervical cancers or cancers in remission for at least 1 year
- Active central nervous system malignancy or recent intrathecal chemotherapy
- Symptomatic extramedullary disease involving CNS or spinal canal
- Autoimmune disease needing active steroid or immunosuppressive treatment within 14 days before treatment
- Use of systemic steroids over 10 mg prednisone equivalent within 14 days before treatment
- QTc interval over 480 msec or family history of long QT syndrome
- Psychiatric or social conditions limiting study compliance
- Other illnesses or medical issues judged to exclude participation by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 cycles of 28 days each
Participants receive the study drug GTB-3650 by continuous infusion during inpatient stays. Each treatment cycle lasts 28 days and consists of two 72-hour infusion blocks followed by about 18 days without treatment. Treatment may continue for up to four cycles if participants meet safety and response criteria.
Inpatient stays for each 72-hour infusion block, 2 blocks per cycle
Trial Site Locations
Total: 1 location
1
Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
M
Mark Juckett, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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