Actively Recruiting
HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML
Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-06-29
45
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 myelogenous leukemia (AML)
- Absolute lymphocyte count (ALC) ≥ 200 cells/µL or absolute circulating CD56+/CD3- NK cell count > 25 cells/µL within 14 days before treatment
- Peripheral blasts ≤ 20,000 at treatment start; hydroxyurea may be used up to Day 1 of first cycle and during first two weeks to maintain this
- Karnofsky performance status ≥ 70%
- Adequate organ function within 14 days (30 days for cardiac) of treatment start
- Agree to use highly effective contraception during treatment and for at least 4 months after last dose if sexually active and of childbearing potential
- For dose finding only: agree to stay within 60-minute drive of study center through Day 29 of first cycle
- Provide voluntary written consent before any research activities
- Pulmonary room air oxygen saturation ≥ 95%
You will not qualify if you...
- Pregnant or breastfeeding
- Candidate for hematopoietic stem cell transplant or newly relapsed after transplant with no post-transplant therapy
- Bi-phenotypic acute leukemia or mixed lineage leukemia
- Acute promyelocytic leukemia (APL)
- No anticancer therapy within 14 days before treatment start; prior therapy adverse events must be resolved to Grade 1 or baseline
- New or progressive pulmonary infiltrates unless infection is stable/improving after appropriate therapy
- Active systemic infection requiring intravenous antibiotics
- Known HIV infection
- Active Hepatitis B or C virus detectable by PCR
- Positive chronic hepatitis B or hepatitis C antibody tests
- Prior malignancy except certain treated skin or cervical cancers or Stage I/II cancers in remission for at least 1 year
- Active central nervous system malignancy or symptoms or recent intrathecal chemotherapy
- Symptomatic extramedullary disease involving CNS or spinal canal
- Autoimmune disease requiring active immunosuppressive treatment within 14 days prior to treatment
- Systemic treatment with steroids > 10 mg prednisone equivalent within 14 days prior to treatment
- QTc interval > 480 msec or family history of long QT syndrome
- Psychiatric or social issues that limit compliance
- Other medical conditions judged by investigator to exclude participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
M
Mark Juckett, MD
CONTACT
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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