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

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMark B Juckett, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: GT Biopharma, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mark B Juckett, MD

Principal Investigator

Masonic Cancer Center, University of Minnesota

Eligibility Criteria

Inclusion Criteria

Not a candidate for hematopoietic stem cell transplant (HSCT), at least one re-induction attempt required

Inclusion Criteria: Eligible Diseases

Revised International Prognostic Scoring System (IPSS-R) High or Very High Risks

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Treatment Details

Interventions

GTB-3550 Tri-Specific Killer Engager (TriKE®) (CAR T-cell Therapy)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: GTB-3550 TriKE® Only (Phase II: Extended Component)Experimental Treatment1 Intervention

The treatment schedule is identical to the dose finding component. The extended component uses a Simon's MiniMax two-stage design for continued enrollment using the maximum tolerated dose (MTD) established during Phase I with monitoring guidelines to stop the study early for excessive toxicity.

Group II: GTB-3550 TriKE® (Phase I: Dose Finding Component)Experimental Treatment1 Intervention

Patients receive a single course of GTB-3550 TriKE® at their assigned dose as 3 weekly treatment blocks. Each block consists of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment is given as an inpatient. The assigned dose will be calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose is not be recalculated for subsequent treatment blocks.