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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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⁃ 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.

• 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%

Locations
United States
Minnesota
Masonic Cancer Center
RECRUITING
Minneapolis
Contact Information
Primary
Mark Juckett, MD
juck0001@umn.edu
612-624-9452
Time Frame
Start Date: 2024-11-19
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 45
Treatments
Experimental: Arm 1: Dose Level 1: 1.25 ug/kg/day
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.
Experimental: Arm 2: Dose Level 2: 2.5 ug/kg/day
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.
Experimental: Arm 3: Dose Level 3: 5 ug/kg/day
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.
Experimental: Arm 4: Dose Level 4: 10 ug/kg/day
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.
Experimental: Arm 5: Dose Level 5: 25 ug/kg/day
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.
Experimental: Arm 6: Dose Level 6: 50 ug/kg/day
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.
Experimental: Arm 7: Dose Level 7: 100 ug/kg/day
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.
Related Therapeutic Areas
Acute Myeloid Leukemia (AML)
Leukemia
Myelodysplastic Syndrome (MDS)
Sponsors
Leads: Masonic Cancer Center, University of Minnesota

This content was sourced from clinicaltrials.gov

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