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NCT05367401
A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants
Phase 1, PHASE2 trial testing Sabatolimab in Myelodysplastic Syndromes. Withdrawn.
26 October 2029
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Start date | 20 December 2024 |
| Primary completion | 26 October 2029 |
| Estimated completion | 26 October 2029 |
Drugs / interventions tested
- Sabatolimab — full drug profile →
- Magrolimab — full drug profile →
- Azacitidine (azacitidine) — full drug profile →
Conditions studied
- Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Myelodysplastic Syndromes or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is to determine the safety and preliminary efficacy of sabatolimab in combination with magrolimab and azacitidine in adult participants with 1L unfit Acute Myeloid Leukemia (AML) or with 1L higher risk Myelodysplastic Syndromes (MDS), and sabatolimab in combination with magrolimab in participants with relapsed or refractory (R/R) AML.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy.
Cai L, Li Y, Tan J, Xu L, et al · · 2023 · cited 232× · PMID 37670328 · DOI 10.1186/s13045-023-01499-1 -
Emerging phagocytosis checkpoints in cancer immunotherapy.
Liu Y, Liu Y, Wang Y, Yang Y, et al · · 2023 · cited 186× · PMID 36882399 · DOI 10.1038/s41392-023-01365-z -
LAG-3, TIM-3, and TIGIT: Distinct functions in immune regulation.
Joller N, Anderson AC, Kuchroo VK. · · 2024 · cited 159× · PMID 38354701 · DOI 10.1016/j.immuni.2024.01.010 -
Recent advances in targeted therapies in acute myeloid leukemia.
Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6 -
Targeting macrophages in hematological malignancies: recent advances and future directions.
Li W, Wang F, Guo R, Bian Z, et al · · 2022 · cited 126× · PMID 35978372 · DOI 10.1186/s13045-022-01328-x -
Drug Resistance Mechanisms of Acute Myeloid Leukemia Stem Cells.
Niu J, Peng D, Liu L. · · 2022 · cited 49× · PMID 35865470 · DOI 10.3389/fonc.2022.896426 -
Deciphering the role of CD47 in cancer immunotherapy.
Liu Y, Liu Y, Weng L, Wang Y, et al · · 2024 · cited 41× · PMID 39167629 · DOI 10.1016/j.jare.2023.10.009 -
Targeting immune checkpoints on tumor-associated macrophages in tumor immunotherapy.
Xu S, Wang C, Yang L, Wu J, et al · · 2023 · cited 40× · PMID 37313405 · DOI 10.3389/fimmu.2023.1199631
Verify or expand the search:
- PubMed search for NCT05367401
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sabatolimab
Trials testing the same drug.
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- NCT04266301 — Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High · Phase 3 · terminated
- NCT04097821 — Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients · Phase 1, PHASE2 · terminated
Other recruiting trials for Myelodysplastic Syndromes
Currently open trials in the same condition.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT06303193 — Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or · Phase 1, PHASE2 · recruiting
- NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting
- NCT07283900 — Ascorbate in Myelodysplastic Syndrome · Phase 2 · recruiting
- NCT06487247 — HEME Home Transfusion Program · NA · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
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- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05367401 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 11 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05367401.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing