10 recruiting, 6 active not recruiting, 5 not yet recruiting, 4 completed. 18 Phase 2, 11 Phase 1, 3 Phase 3.
Follow axatilimab: new trials by email Literature Review of axatilimab trials Research Report on axatilimab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML Decitabine, Venetoclax, Axatilimab - Acute Myeloid Leukemia, TP53 Gene Mutation | Phase 1 | Not yet recruiting | Northside Hospital, Inc. | 32 | 2027-01-31 | 2026-10-16 |
| Axatilimab + CAR-T for High-Risk Lymphoma Axatilimab - Diffuse Large B Cell Lymphoma (DLBCL), Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma | Phase 1 | Not yet recruiting | Northside Hospital, Inc. | 29 | 2026-12-31 | 2026-10-16 |
| CSF-1R Inhibitor, Axatilimab, for Prevention of Acute and Chronic GVHD After HLA-Matched Related and Unrelated Donor Allogeneic Stem Cell Transplantation Hematopoietic Cell Transplantation, Cyclophosphamide, Tacrolimus - Graft -Versus-host-disease | Phase 2 | Not yet recruiting | Medical College of Wisconsin | 72 | 2026-11-01 | 2026-09-08 |
| Effects of Axatilimab on Skin in Chronic Graft-versus-Host Disease Axatilimab - Chronic Graft vs. Host Disease, GVHD | Not yet recruiting | Northwestern University | 15 | 2026-11-01 | 2026-09-22 | |
| ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation Pembrolizumab, Radiotherapy, Axatilimab - TNBC - Triple-Negative Breast Cancer, Breast Cancer | Phase 2 | Not yet recruiting | Stephen Shiao | 34 | 2026-06-01 | 2026-04-20 |
| Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial Allogeneic Hematopoietic Stem Cell Transplantation, Axatilimab, Biospecimen Collection - Hematopoietic and Lymphatic System Neoplasm | Phase 2 | Withdrawn | Mayo Clinic | 2026-06-01 | 2026-09-03 | |
| A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) INCA034176, Best available Treatment (BAT) - Chronic Graft-versus-host-disease | Phase 2 | Recruiting | Incyte Corporation | 60 | 2026-05-20 | 2026-10-09 |
| Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML) Axatilimab (SNDX-6352), Ruxolitinib - Myelofibrosis (MF), Chronic Myelomonocytic Leukemia (CMML) | Phase 1 / Phase 2 | Recruiting | M.D. Anderson Cancer Center | 66 | 2026-01-02 | 2026-10-09 |
| A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC) Cyclophosphamide, Axatilimab (SNDX-6352), Retifanlimab - Breast Cancer | Phase 1 | Suspended | M.D. Anderson Cancer Center | 24 | 2025-08-13 | 2026-10-05 |
| Axatilimab for Sclerotic Chronic Graft-versus-Host Disease Axatilimab, Biospecimen Collection, Questionnaire Administration - Chronic Graft Versus Host Disease | Phase 2 | Recruiting | Fred Hutchinson Cancer Center | 50 | 2025-08-06 | 2026-09-24 |
| A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD INCA034176 - Chronic Graft-versus-host-disease | Phase 1 / Phase 2 | Active not recruiting | Incyte Corporation | 32 | 2025-06-25 | 2026-08-10 |
| A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy INCA034176, Best Available Therapy (BAT) - Chronic Graft-versus-host-disease | Phase 3 | Active not recruiting | Incyte Corporation | 9 | 2025-06-04 | 2026-08-25 |
| Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease Axatilimab, Extracorporeal Photopheresis - Chronic Graft Versus Host Disease, cGVHD | Phase 2 | Recruiting | University of Miami | 49 | 2025-05-05 | 2026-06-22 |
| A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease INCA034176, Placebo, Corticosteroids - Chronic Graft-versus-host-disease | Phase 3 | Recruiting | Incyte Corporation | 240 | 2025-01-21 | 2026-10-30 |
| A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants Axatilimab - Healthy Participants | Phase 1 | Completed | Incyte Corporation | 72 | 2025-01-14 | 2025-06-25 |
| A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease Axatilimab, Ruxolitinib, Corticosteroids - Chronic Graft-versus-host-disease | Phase 2 | Active not recruiting | Incyte Corporation | 130 | 2024-10-11 | 2026-10-15 |
| Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer Axatilimab, Olaparib - Breast Cancer, PALB2-Mutated Breast Carcinoma | Phase 1 | Recruiting | Dana-Farber Cancer Institute | 20 | 2024-08-13 | 2026-09-02 |
| Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia Axatilimab, Azacitidine, Biospecimen Collection - Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia | Phase 1 / Phase 2 | Recruiting | Uma Borate | 49 | 2024-08-02 | 2026-08-27 |
| A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease INCA034176 - Chronic Graft-versus-host-disease | Phase 3 | Active not recruiting | Incyte Biosciences Japan GK | 21 | 2024-07-30 | 2026-10-05 |
| Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors Axatilimab, Biopsy, Biospecimen Collection - Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm | Phase 1 / Phase 2 | Recruiting | OHSU Knight Cancer Institute | 38 | 2024-05-21 | 2026-07-08 |
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Bronchiolitis Obliterans Syndrome (10) · Breast Neoplasms (4) · Graft vs Host Disease (2) · Leukemia, Myelomonocytic, Chronic (2) · Neoplasm Metastasis (2) · Triple Negative Breast Neoplasms (2) · Cholangiocarcinoma (1) · Coronavirus Infections (1) · Cytokine Release Syndrome (1) · Hematologic Neoplasms (1) · Hodgkin Disease (1) · Idiopathic Pulmonary Fibrosis (1) · Leukemia, Myeloid, Acute (1) · Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative (1) · Lymphoma, Follicular (1)
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