IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

Sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study ID
NCT06647862
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronic Myelomonocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMM01 — DRUG
    IV infusion
  • Azacitidine — DRUG
    subcutaneous injection
  • Placebo — DRUG
    IV infusion

Study Details

This study is a randomized, controlled, double-blind, multicenter, phase Ⅲ clinical study to evaluate the efficacy of IMM01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (CMML1-2).Primary endpoint are Complete remission rate and Overall survival.

Key Dates

First listed
Oct 18, 2024
Start date
Nov 11, 2024
Status verified
Nov 2025
Primary completion
Apr 24, 2026
Completion
Oct 24, 2029

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IMM01 in combination with azacitidine
    One treatment cycle consists of 4 weeks (28 days). IMM01(timdarpacept) will be administered once weekly, and azacitidine will be administered from Day 1 to Day 7 of each cycle.
  • Placebo Comparator: placebo in combination with azacitidine
    One treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and azacitidine will be administered on days 1-7 of each cycle.

Primary Outcome Measure

Complete remission( CR) rate [ Time Frame: approximately 24 months ]

Central Contacts

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