Myeloid MalignancyPhase 1NCT06594445
HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML
A Phase 1 study testing GTB-360 in people with Myeloid Malignancy and Acute Myeloid Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- GTB-360
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2024to 30 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 circulating CD56+/CD3- NK cell count >25 cells/µL within the 14 days prior to Cycle 1 Day 1.
- Peripheral blasts ≤20,000 at the time of treatment start. Hydroxyurea may be used up to Day 1 of the 1st cycle to achieve this threshold and 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) of Cycle 1 Day 1
- Sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the last dose of GTB-3650. Non-childbearing is defined as >1 year postmenopausal or surgically sterilized.
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- -For the Dose Finding Component Only: Must agree to stay within a 60- minute drive of the Study Center through the Cycle 1 Day 29 visit (end of the Dose Limiting Toxicity period).
- Provides voluntary written consent prior to the performance of any research related activity.
- Pulmonary: room air 0 2 saturation at ≥ 95%
Who cannot join
- Pregnant or breast-feeding. The effect of GTB-3650 TriKE on the fetus is unknown. Persons of childbearing potential must have a negative serum or urine test within 7 days prior to Cycle 1 Day 1 to rule out pregnancy.
- A candidate for hematopoietic stem cell transplant (HSCT) or newly relapsed after HSCT (e.g. no post-HSCT therapy given).
- Bi-phenotypic acute leukemia or mixed lineage leukemia.
- Acute promyelocytic leukemia (APL).
- No anticancer therapy within 14 days of Cycle 1 Day 1; any AEs from therapy given prior must have resolved to Grade 1 or baseline
- New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable/improving with associated clinical improvement after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).
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- Active systemic infection requiring parenteral antibiotic therapy. Any prior systemic infections must have resolved following optimal therapy.
- Known history of HIV.
- Active Hepatitis B or Hepatitis C (virus detectable by PCR) - chronic asymptomatic viral hepatitis is allowed.
- Positive test results from chronic hepatitis B infection (defined as positive HBsAg serology) and/or positive test results for hepatitis C (HCV antibody serology test).
- Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer currently in complete remission, or any other cancer from which the patient has been disease-free for 1 year
- Active central nervous system (CNS) malignancy or symptoms of CNS spread or administration of IT chemotherapy within 14 days prior to Day 1.
- Extramedullary disease causing symptoms and/or involving the CNS or spinal canal - asymptomatic extramedullary disease outside the CNS and spinal canal is eligible provided the marrow has measurable disease.
- Known autoimmune disease requiring active treatment with steroids or other immunosuppressive medications within 14 days before Cycle 1 Day. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Persons with a condition requiring systemic treatment with steroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before Cycle 1 Day 1.
- The potential risk of QT/QTc prolongation is unknown in humans receiving
- TriKE therefore either of the following is an exclusion criteria:
- QTc interval > 480 msec at screening
- A family history of long QT syndrome
- Psychiatric illness/social situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements.
- Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Masonic Cancer Center
Minneapolis, Minnesota, 55455
Mark Juckett, MD
About this study
Official title: HM2023-05: GTB-3650 (Anti-CD16/IL-15/Anti-CD33) Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (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 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
- Being tested
- GTB-360
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTB-360Drug
Also called anti-CD16/IL-15/anti-CD33
GTB-3650 is administered by a continuous infusion (CI). A patient's dose of GTB-3650 is calculated using their assigned Dose Level and their actual body weight (ABW) obtained within 5 days prior to or on Cycle 1, Day 1.
Dose Level 1: 1.25 ug/kg/day Dose Level 2: 2.5 ug/kg/day Dose Level 3: 5 ug/kg/day Dose Level 4: 10 ug/kg/day Dose Level 5: 25 ug/kg/day Dose Level 6: 50 ug/kg/day Dose Level 7: 100 ug/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Dose Level 1: 1.25 ug/kg/day | Experimental | GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block".
A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. Receives: Drug: GTB-360 |
| Arm 2: Dose Level 2: 2.5 ug/kg/day | Experimental | GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block".
A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. Receives: Drug: GTB-360 |
| Arm 3: Dose Level 3: 5 ug/kg/day | Experimental | GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block".
A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. Receives: Drug: GTB-360 |
| Arm 4: Dose Level 4: 10 ug/kg/day | Experimental | GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block".
A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. Receives: Drug: GTB-360 |
| Arm 5: Dose Level 5: 15 ug/kg/day | Experimental | GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block".
A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. Receives: Drug: GTB-360 |
| Arm 6: Dose Level 6: 22 ug/kg/day | Experimental | GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block".
A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. Receives: Drug: GTB-360 |
| Arm 7: Dose Level 7: 33 ug/kg/day | Experimental | GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block".
A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. Receives: Drug: GTB-360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD (ug/kg/day)
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.
Measured: 6 months
Secondary outcomes (3)
Number of Participants With Adverse Events as a Measure of Safety and Feasibility ofGTB-3650 TriKE.
Evaluate the safety and feasibility of GTB-3650 TriKE repeat dosing based on the incidence of adverse events (AEs) using CTCAE v5 grading unless otherwise indicated.
Measured: 6 months
Event free survival
Event free survival (EFS) defined as time to death, relapse after a complete remission (CR), or progression (no remission and requires a change in therapy for disease control)
Measured: 6 months
Overall survival (OS)
Overall survival (OS) at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Nov 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid MalignancyStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594445
- Sponsor's protocol ID
- 2023LS024
- Status last verified
- Jul 2026
- First submitted
- 10 Sep 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HM2023-05: GTB-3650 (Anti-CD16/IL-15/Anti-CD33) Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT06594445
- Acronym / sponsor ID
- 2023LS024
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Dose Level 1: 1.25 ug/kg/day | Experimental | Drug: GTB-360GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block". A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. |
| Arm 2: Dose Level 2: 2.5 ug/kg/day | Experimental | Drug: GTB-360GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block". A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. |
| Arm 3: Dose Level 3: 5 ug/kg/day | Experimental | Drug: GTB-360GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block". A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. |
| Arm 4: Dose Level 4: 10 ug/kg/day | Experimental | Drug: GTB-360GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block". A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. |
| Arm 5: Dose Level 5: 15 ug/kg/day | Experimental | Drug: GTB-360GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block". A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. |
| Arm 6: Dose Level 6: 22 ug/kg/day | Experimental | Drug: GTB-360GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block". A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. |
| Arm 7: Dose Level 7: 33 ug/kg/day | Experimental | Drug: GTB-360GTB-3650 is administered during an inpatient stay by continuous infusion (CI) consisting of three consecutive 24 hour infusion "bags" over a 72 hour period. Each 72-hour infusion period is designated a "block". A 28-day treatment cycle consists of two blocks followed by approximately 18 days of no treatment. Prior to each block start, the patient must meet the safety criteria.GTB-3650 may continue for up to four treatment cycles total provided disease based response criteria is met and the patient is otherwise eligible to continue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 circulating CD56+/CD3- NK cell count >25 cells/µL within the 14 days prior to Cycle 1 Day 1.
- Peripheral blasts ≤20,000 at the time of treatment start. Hydroxyurea may be used up to Day 1 of the 1st cycle to achieve this threshold and 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) of Cycle 1 Day 1
Key exclusion criteria (21 listed)
- Pregnant or breast-feeding. The effect of GTB-3650 TriKE on the fetus is unknown. Persons of childbearing potential must have a negative serum or urine test within 7 days prior to Cycle 1 Day 1 to rule out pregnancy.
- A candidate for hematopoietic stem cell transplant (HSCT) or newly relapsed after HSCT (e.g. no post-HSCT therapy given).
- Bi-phenotypic acute leukemia or mixed lineage leukemia.
- Acute promyelocytic leukemia (APL).
- No anticancer therapy within 14 days of Cycle 1 Day 1; any AEs from therapy given prior must have resolved to Grade 1 or baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTB-360Also: anti-CD16/IL-15/anti-CD33GTB-3650 is administered by a continuous infusion (CI). A patient's dose of GTB-3650 is calculated using their assigned Dose Level and their actual body weight (ABW) obtained within 5 days prior to or on Cycle 1, Day 1. Dose Level 1: 1.25 ug/kg/day Dose Level 2: 2.5 ug/kg/day Dose Level 3: 5 ug/kg/day Dose Level 4: 10 ug/kg/day Dose Level 5: 25 ug/kg/day Dose Level 6: 50 ug/kg/day Dose Level 7: 100 ug/kg/day | Drug | Arm 1: Dose Level 1: 1.25 ug/kg/day, Arm 2: Dose Level 2: 2.5 ug/kg/day, Arm 3: Dose Level 3: 5 ug/kg/day, Arm 4: Dose Level 4: 10 ug/kg/day, Arm 5: Dose Level 5: 15 ug/kg/day, Arm 6: Dose Level 6: 22 ug/kg/day, Arm 7: Dose Level 7: 33 ug/kg/day |
Primary outcome
MTD (ug/kg/day)
Time frame: 6 months
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.
3 secondary outcomes
Number of Participants With Adverse Events as a Measure of Safety and Feasibility ofGTB-3650 TriKE.
Time frame: 6 months
Event free survival
Time frame: 6 months
Overall survival (OS)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GTB-360 in people with Myeloid Malignancy and Acute Myeloid Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Juckett, MD (612-624-9452, juck0001@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (ug/kg/day) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.