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Tri-Specific Killer Engager
GTB-3650 for Myelodysplastic Syndrome and Acute Myeloid Leukemia
Phase 1
Recruiting
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Active systemic infection requiring parenteral antibiotic therapy. Any prior systemic infections must have resolved following optimal therapy
A candidate for hematopoietic stem cell transplant (HSCT) or newly relapsed after HSCT (e.g. no post-HSCT therapy given)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to test a new treatment called GTB-3650 for adults with certain types of blood cancer who have not responded to other treatments. The treatment works by activating natural killer cells to attack
Who is the study for?
This trial is for adults over 18 with certain types of myeloid leukemia or myelodysplastic syndrome who can't have curative therapy like a stem cell transplant. They must have an adequate number of lymphocytes or natural killer cells, not too many leukemia cells in the blood, and good organ function. Participants need to stay close to the Study Center for a month and use effective contraception if they can have children.
What is being tested?
The study tests GTB-3650 TriKE®, which aims to boost natural killer (NK) cell activity against CD33-expressing cancer cells and immune-suppressing cells in patients with refractory/relapsed myeloid malignancies. It's a Phase I trial focused on finding the right dose for this new treatment.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on IV antibiotics for an infection or have recovered from a recent infection with treatment.
Select...
I am eligible for a stem cell transplant or have recently relapsed after one without any further treatment.
Select...
My leukemia is of a mixed or dual type.
Select...
I have been diagnosed with acute promyelocytic leukemia.
Select...
I have a known history of HIV.
Select...
I do not have an active brain tumor or symptoms of cancer spread to the brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MTD (ug/kg/day)
Secondary study objectives
Event free survival
Number of Participants With Adverse Events as a Measure of Safety and Feasibility ofGTB-3650 TriKE.
Overall survival (OS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: Arm 7: Dose Level 7: 100 ug/kg/dayExperimental Treatment1 Intervention
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.
Group II: Arm 6: Dose Level 6: 50 ug/kg/dayExperimental Treatment1 Intervention
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.
Group III: Arm 5: Dose Level 5: 25 ug/kg/dayExperimental Treatment1 Intervention
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.
Group IV: Arm 4: Dose Level 4: 10 ug/kg/dayExperimental Treatment1 Intervention
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.
Group V: Arm 3: Dose Level 3: 5 ug/kg/dayExperimental Treatment1 Intervention
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.
Group VI: Arm 2: Dose Level 2: 2.5 ug/kg/dayExperimental Treatment1 Intervention
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.
Group VII: Arm 1: Dose Level 1: 1.25 ug/kg/dayExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
281 Previous Clinical Trials
15,562 Total Patients Enrolled