67 Participants Needed

IO-202 + Azacitidine/Venetoclax for AML and CMML

Recruiting at 25 trial locations
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Overseen ByYasuhiro Tabata, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with AML with monocytic differentiation and CMML in order to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D)

Research Team

HX

Hong Xiang, PhD

Principal Investigator

Immune-Onc Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

I have CMML and have never been treated with hypomethylating agents.
I have AML that didn't respond to treatment and fits specific types.
I have CMML that didn't respond to treatment or has come back.
See 11 more

Exclusion Criteria

I currently have an active infection.
Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol
Patients who are pregnant or breastfeeding
See 20 more

Treatment Details

Interventions

  • Azacitidine
  • IO-202
  • Venetoclax
Trial OverviewThe 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.
Participant Groups
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.

Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Vidaza for:
  • Acute myeloid leukemia
  • Chronic myelomonocytic leukemia
  • Myelodysplastic syndromes
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Approved in United States as Vidaza for:
  • Myelodysplastic syndromes
  • Chronic myelomonocytic leukemia
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Approved in Canada as Vidaza for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia
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Approved in Japan as Vidaza for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Immune-Onc Therapeutics Inc

Lead Sponsor

Trials
3
Recruited
180+

Immune-Onc Therapeutics

Lead Sponsor

Trials
5
Recruited
740+

California Institute for Regenerative Medicine (CIRM)

Collaborator

Trials
70
Recruited
3,300+