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Anti-metabolites

IO-202 + Azacitidine/Venetoclax for AML and CMML

Phase 1
Recruiting
Research Sponsored by Immune-Onc Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For the Part 1 Dose-Escalation Phase, patients must be diagnosed with relapsed or refractory AML with myelomonocytic or monoblastic/monocytic differentiation according to the World Health Organization 2016 criteria and has failed treatment with available therapies known to be active for AML
For the Part 1 Dose-Escalation Phase, patients must be diagnosed with relapsed or refractory CMML and has failed treatment with available therapies known to be active for CMML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing a new drug for people with relapsed or refractory AML with monocytic differentiation and CMML. They are trying to find the best dose of the new drug.

Who is the study for?
This trial is for adults (18+) with certain types of blood cancer: relapsed or refractory Acute Myeloid Leukemia (AML) with specific differentiation, or Chronic Myelomonocytic Leukemia (CMML). Participants must have failed previous treatments and be in good enough health to give consent and undergo regular bone marrow/blood tests. Pregnant women, those with other severe illnesses, recent transplants, or known allergies to similar drugs cannot join.Check my eligibility
What is being tested?
The study is testing IO-202 alone and combined with Azacitidine ± Venetoclax in patients with AML and CMML. It aims to find the safest high dose (MTD/MAD) for future studies by gradually increasing amounts in different groups of participants until they reach a level that's effective but tolerable.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system due to the drug's targeting properties, as well as typical chemotherapy-related issues like fatigue, digestive problems, increased risk of infection, possible liver or kidney function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have AML that didn't respond to treatment and fits specific types.
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I have CMML that didn't respond to treatment or has come back.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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My AML has returned or didn't respond to treatment, and it's a specific type with high LILRB4.
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My liver is working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of IO-202 and IO-202 plus azacitidine ± venetoclax as measured by incidence of adverse events.
Tolerability of IO-202 and IO-202 plus azacitidine ± venetoclax as measured by incidence and duration of dose interruptions and dose reductions of study treatment.
Secondary outcome measures
To characterize the PK of IO-202 and IO-202 IO-202 plus azacitidine ± venetoclax as defined by area under the curve (AUC)
To characterize the pharmacokinetics (PK) of IO-202 and IO-202 plus azacitidine ± venetoclax and as defined by maximum plasma concentration (Cmax)
To evaluate the incidence of anti-drug antibodies against IO-202
+1 more
Other outcome measures
To correlate target expression with rates of adverse events
To correlate target expression with response rates
To evaluate immunophenotype of leukemic blasts after study treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Dose Expansion of IO-202 plus Azacitidine CMMLExperimental Treatment1 Intervention
To enroll hypomethylating-agent naive CMML patients.
Group II: Dose Expansion of IO-202 plus Azacitidine AMLExperimental Treatment1 Intervention
To enroll high LILRB4 expression monocytic AML patients refractory to or relapsed after available therapies known to be active in AML.
Group III: Dose Expansion of IO-202 plus Azacitidine + Venetoclax (Ven)Experimental Treatment1 Intervention
To enroll newly diagnosed high LILRB4 expression AML patients who are unfit for intensive induction chemotherapy.
Group IV: Dose Escalation of IO-202 Plus AzacitidineExperimental Treatment1 Intervention
AZA Dose cohorts treated with intravenous (IV) IO-202 in ascending doses plus Azacitidine (IV or SC) on days 1-7 of each 28-day cycle.
Group V: Dose Escalation of IO-202Experimental Treatment1 Intervention
Dose cohorts treated with intravenous (IV) IO-202 monotherapy in ascending doses.

Find a Location

Who is running the clinical trial?

Immune-Onc Therapeutics IncLead Sponsor
2 Previous Clinical Trials
509 Total Patients Enrolled
Immune-Onc TherapeuticsLead Sponsor
3 Previous Clinical Trials
598 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
63 Previous Clinical Trials
3,048 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04372433 — Phase 1
Chronic Myelomonocytic Leukemia Research Study Groups: Dose Expansion of IO-202 plus Azacitidine AML, Dose Expansion of IO-202 plus Azacitidine CMML, Dose Expansion of IO-202 plus Azacitidine + Venetoclax (Ven), Dose Escalation of IO-202 Plus Azacitidine, Dose Escalation of IO-202
Chronic Myelomonocytic Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04372433 — Phase 1
Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04372433 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on the potential hazards of IO-202?

"Limited safety and efficacy data for IO-202 warrants a score of 1 on our team's assessment scale. As this is a Phase 1 trial, the risks associated with participating are relatively high."

Answered by AI

What primary goals has this experiment been designed to accomplish?

"The primary goal of this medical experiment, which will be observed from the first dose to 30 days following the last treatment instance, is assessing safety as indicated by adverse events. Secondary objectives include quantifying IO-202's PK through AUC measurement, gauging response rates in patients with anti-drug antibodies, and determining Cmax for IO-202."

Answered by AI

In what geographical locations is this experiment taking place?

"The list of medical centres offering this clinical trial are numerous. Winship Cancer Institute at Emory University in Atlanta, the University of California San Francisco and Davis, as well as other twelve sites across the nation all provide access to this treatment."

Answered by AI

Are there still opportunities for individuals to participate in this experiment?

"The trial, initially posted on September 14th 2020 and last revised on May 3rd 2022, is still seeking participants. This fact can be confirmed by visiting clinicaltrials.gov."

Answered by AI

What is the maximum number of individuals eligible for this experiment?

"Affirmative. According to clinicaltrials.gov, the research in question is currently seeking volunteers and opened recruitment on September 14th 2020. As of May 3rd 2022, 119 participants need to be recruited at a dozen different sites for this study."

Answered by AI
~36 spots leftby Jan 2026