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HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML

ConditionsMyeloid MalignancyAcute Myeloid LeukemiaMyelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • GTB-360

    Drug

    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

Treatment groups

45 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Arm 1: Dose Level 1: 1.25 ug/kg/dayExperimental treatment 1 intervention
Group B: Arm 2: Dose Level 2: 2.5 ug/kg/dayExperimental treatment 1 intervention
Group C: Arm 3: Dose Level 3: 5 ug/kg/dayExperimental treatment 1 intervention
Group D: Arm 4: Dose Level 4: 10 ug/kg/dayExperimental treatment 1 intervention
Group E: Arm 5: Dose Level 5: 15 ug/kg/dayExperimental treatment 1 intervention
Group F: Arm 6: Dose Level 6: 22 ug/kg/dayExperimental treatment 1 intervention
Group G: Arm 7: Dose Level 7: 33 ug/kg/dayExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

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)

Time frame
6 months
3

Overall survival (OS)

Overall survival (OS) at 6 months

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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