TerminatedPhase 1/2

GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies

Stopped: Development of GTB-3550 halted due to development of the second generation camelid nanobody TriKE drug product, GTB-3650.

United States12 participantsStarted 2020-01-01

Plain-language summary

This is a multi-center Phase I/II clinical trial of GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE®) for the treatment of CD33-expressing high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis. The hypothesis is that GTB-3550 TriKE® will induce natural killer cell function by targeting malignant cells as well as CD33+ myeloid derived suppressor cells (MDSC) which contribute to tumor induced immunosuppression. Because CD16 is the most potent activating receptor on natural killer (NK) cells, this single agent may induce a targeted anti-CD33+ tumor response.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Eligible Diseases * Diagnosis of one of the following CD33-expressing myeloid malignancies with greater than or equal to 50% CD33+ target cells with no good standard of care treatment options including: * High Risk Myelodysplastic Syndromes (MDS) progressive on two or more prior regimens and requiring treatment that meets at least one of the following: * Revised International Prognostic Scoring System (IPSS-R) High or Very High Risks * World Health Organization (WHO) Classification: Refractory anemia with excess blasts-1 (RAEB-1) or RAEB-2 * Poor and very-poor risk cytogenetic abnormality as defined by the IPSS-R cytogenetic classifications * WHO Based Prognostic Scoring System (WPSS): High or Very High Risk * Therapy related MDS and not a candidate for induction chemotherapy or had an inadequate treatment response after induction chemotherapy. * Refractory or Relapsed Acute Myelogenous Leukemia (AML) meeting at least one of the following: * Refractory AML defined as failure to achieve remission after at least 3 induction attempts \*\* Elderly AML not fit for induction therapy can be enrolled after 2 failed inductions * Relapsed AML * Not a candidate for hematopoietic stem cell transplant (HSCT), at least one re-induction attempt required * Prior HSCT relapse beyond 3 months may be included only if off immunosuppression for a minimum of 4 weeks and do not have graft-versus-host disease (GVHD) * Advanced systemic mastocytosis (d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

GTB-3550 Dosing Summary

Timeframe: Day 1 (start of GTB-3550 therapy)

GTB-3550 Extent of Treatment (Summary)

Timeframe: Day 28 relative to the start of GTB-3550 therapy

Trial details

NCT IDNCT03214666

SponsorGT Biopharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-02

Results submitted2022-09-07

View on ClinicalTrials.gov More High-risk Myelodysplastic Syndromes trials