IO-202 + Azacitidine/Venetoclax for AML and CMML

Recruiting in Cleveland (>99 mi)

+25 other locations

Overseen By Yasuhiro Tabata, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Immune-Onc Therapeutics Inc

Must not be taking: Monoclonal antibodies, Corticosteroids

Disqualifiers: Pregnancy, Active infection, CHF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

67 Participants Needed

What You Need to Know Before You Apply

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)

Who Is on the Research Team?

Hong Xiang, PhD

Principal Investigator

Immune-Onc Therapeutics

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive IO-202 monotherapy or IO-202 plus Azacitidine in ascending doses to assess safety and tolerability

28-day cycles

Multiple visits per cycle

Dose Expansion

Participants receive IO-202 plus Azacitidine ± Venetoclax to further evaluate safety and clinical activity

28-day cycles

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Azacitidine
• IO-202
• Venetoclax

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose Expansion of IO-202 plus Azacitidine CMML Experimental Treatment 1 Intervention

To enroll hypomethylating-agent naive CMML patients.

Group II: Dose Expansion of IO-202 plus Azacitidine AML Experimental Treatment 1 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 Treatment 1 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 Azacitidine Experimental Treatment 1 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-202 Experimental Treatment 1 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

Approved in United States as Vidaza for:

• Myelodysplastic syndromes
• Chronic myelomonocytic leukemia

Approved in Canada as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

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+