NIS793 for Myelodysplastic Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Myelodysplastic Syndromes+2 More
NIS793 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety and tolerability of different cancer drugs in patients with low-risk blood disorders.

Eligible Conditions
  • Myelodysplastic Syndromes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

4 Primary · 14 Secondary · Reporting Duration: 30 Months

30 Months
Characterize pharmacokinetics for single agents and combinations: Cmax
Characterize pharmacokinetics for single agents and combinations: Ctrough
Characterize pharmacokinetics for single agents and combinations: Tmax
Characterize the prevalence of immunogenicity
Dose intensity
Dose interruption reduction
Efficacy of single agents and combinations in patients who are transfusion independent: Best Overall Response (BOR)
Efficacy of single agents and combinations in patients who are transfusion independent: Duration of Response (DOR)
Efficacy of single agents and combinations in patients who are transfusion independent: Overall Response Rate (ORR)
Efficacy of single agents and combinations in patients who are transfusion independent: Progression Free Survival (PFS)
Efficacy of single agents and combinations in patients who are transfusion independent: Time to Progression (TTP)
Efficacy of single agents and combinations on transfusion dependent patients: Best Overall Response (BOR)
Efficacy of single agents and combinations on transfusion dependent patients: Duration of Response (DOR)
Efficacy of single agents and combinations on transfusion dependent patients: Overall Response Rate (ORR)
Efficacy of single agents and combinations on transfusion dependent patients: Progression free survival (PFS)
Efficacy of single agents and combinations on transfusion dependent patients: Time to progression (TTP)
Incidence of DLTs
30 months
AE and SAE indicence

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

5 Treatment Groups

Arm 1: MBG453 single agent
1 of 5
Arm 4: MBG453 + NIS793 combination
1 of 5
Arm 3: canakinumab single agent
1 of 5
Arm 2: NIS793 single agent
1 of 5
Arm 5: MBG453 + canakinumab combination
1 of 5

Experimental Treatment

90 Total Participants · 5 Treatment Groups

Primary Treatment: NIS793 · No Placebo Group · Phase 1

Arm 1: MBG453 single agent
Drug
Experimental Group · 1 Intervention: MBG453 · Intervention Types: Drug
Arm 4: MBG453 + NIS793 combinationExperimental Group · 2 Interventions: NIS793, MBG453 · Intervention Types: Drug, Drug
Arm 3: canakinumab single agent
Drug
Experimental Group · 1 Intervention: canakinumab · Intervention Types: Drug
Arm 2: NIS793 single agent
Drug
Experimental Group · 1 Intervention: NIS793 · Intervention Types: Drug
Arm 5: MBG453 + canakinumab combinationExperimental Group · 2 Interventions: MBG453, canakinumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NIS793
2017
Completed Phase 1
~120
Canakinumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 months

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,694 Previous Clinical Trials
3,522,969 Total Patients Enrolled
36 Trials studying Myelodysplastic Syndromes
3,470 Patients Enrolled for Myelodysplastic Syndromes

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Anemia that is causing symptoms and has a hemoglobin level of less than 10 grams per deciliter, and has not responded to or has stopped responding to erythropoietin stimulators (ESA) therapy, or the patient is not able to tolerate ESA therapy.
) People who have symptomatic anemia and a hemoglobin level of less than 10 g/dL and have never been treated with ESA therapy and have an EPO level of at least 500/uL are candidates for EPO therapy.
The patient has neutropenia with an ANC of <500 or 1000/ µL and recurrent and/or severe infections
or pomalidomide are potential candidates for carfilzomib For patients who are not responding to, intolerant of, or ineligible/ unable to receive standard of care therapeutic options including lenalidomide or pomalidomide, carfilzomib may be a potential treatment option.
This text is about a condition called thrombocytopenia, which is a decrease in the number of platelets in the blood
Before you take part in the study, you must agree to give your informed consent
You must be at least 18 years old in order to sign the informed consent form.
The patient must be eligible for serial bone marrow aspirate and/or biopsy according to the study's guidelines, and be willing to undergo a bone marrow aspirate and/or biopsy at screening, during and at the end of therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.