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

StatusRecruiting
PhasePhase 3
Started2024-11-11
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 25, 2025 (before its estimated April 24, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-11-23
Study Status, Eligibility v3
Eligibility criteria-5 characters
[...] th the study drug (hydroxyurea and leukapheresis are allowed, but not within 3 days prior to the first treatment with the study drug). Patients must be treatment-naïve to any hypomethylatingsystemic agents for CMML (e.g., azacitidine, decitabine,chemotherapy<1 cycle, and the washout period should be more than 28 days, which is acceptable.), chemotherapy or allogeneic stem cell transplant for CMML. Immunomodulators ( lenalidomide), immunosuppressants (antithymocyte globulin, cyclosporine), targeted agents (ruxolitinib), etc. are also excluded, as these agents are considered disease-modifying t [...] [...]
2025-03-13
Study Status, Eligibility, Contacts/Locations v2
Primary completion date2026-10-24→2026-04-24
Start dateestimated 2024-10-24→confirmed 2024-11-11
Study sites22→43
Eligibility criteria-13 characters
[...] allogeneic stem cell transplant for CMML. Immunomodulators (thalidomide, lenalidomide), immunosuppressants (antithymocyte globulin, [...] e undergone autologous haematopoietic stem cell transplant; No priorPrior diagnosis of: therapy-related myelodysplastic syndrome(t-MD [...] ents positive for BCR-ABL fusion genes, PDGFRA, PDGFRB, and FGF1FGFR1 rearrangements need to be excluded; Current or history of c [...] loid sarcoma; Diagnosis of other malignant neoplasms within 53 years prior to the first dose. Exceptions: a. Radically tre [...] at has been curatively treated and has no recurrence within fivethree years;
2024-10-18
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v1
Eligibility criteria+20 characters
[...] tem cell transplant; No prior diagnosis of: therapy-related MDSmyelodysplastic syndrome(t-MDS); MDS evolved from a pre-existing myeloproliferative [...]
Secondary endpoints8 entries, revised
Event-free survival(EFS) Progression-free survival(PFS) Time to response (TTR) ORR DOR CRoverall response rate(ORR) Duration of response(DOR) Complete remission(CR) rate
Primary endpoints2 entries, revised
Complete remission( CR) rate Overall survival (OS)
Study title-30 characters
AIMM01+Azacitidine PhaseVS ⅢPlacebo Study of IMM01 (Timdarpacept) in Combination With +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
2024-10-16
Original filing
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.
Trial Details
NCT Number NCT06647862
Lead Sponsor ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Conditions Chronic Myelomonocytic Leukemia
Enrollment 170 participants
Start Date 2024-11-11
Primary Completion 2026-04-24 (estimated)
Study Completion 2029-10-24 (estimated)
Updated on ClinicalTrials.gov 2025-11-25