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NCT04810611
Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS
Phase 1 trial testing MBG453 in Myelodysplastic Syndromes in 33 participants. Terminated before completion.
19 April 2024
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 18 June 2021 |
| Primary completion | 19 April 2024 |
| Estimated completion | 19 April 2024 |
| Sites | 13 locations across Italy, Israel, South Korea, Australia, Singapore, United States, Spain |
Drugs / interventions tested
- MBG453 — full drug profile →
- NIS793 — full drug profile →
- canakinumab (CANAKINUMAB) — full drug profile →
Conditions studied
- Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study was to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) MDS.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting TGF-β signal transduction for fibrosis and cancer therapy.
Peng D, Fu M, Wang M, Wei Y, et al · · 2022 · cited 752× · PMID 35461253 · DOI 10.1186/s12943-022-01569-x -
TGF-β signaling in health, disease, and therapeutics.
Deng Z, Fan T, Xiao C, Tian H, et al · · 2024 · cited 737× · PMID 38514615 · DOI 10.1038/s41392-024-01764-w -
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 -
Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0 -
TGF-beta signal transduction: biology, function and therapy for diseases.
Tie Y, Tang F, Peng D, Zhang Y, et al · · 2022 · cited 97× · PMID 36534225 · DOI 10.1186/s43556-022-00109-9 -
TIM-3 as a promising target for cancer immunotherapy in a wide range of tumors.
Sauer N, Janicka N, Szlasa W, Skinderowicz B, et al · · 2023 · cited 89× · PMID 37567938 · DOI 10.1007/s00262-023-03516-1 -
Immune Checkpoint Inhibition in Acute Myeloid Leukemia and Myelodysplastic Syndromes.
Abaza Y, Zeidan AM. · · 2022 · cited 61× · PMID 35883692 · DOI 10.3390/cells11142249 -
Involvement of inflammasomes in tumor microenvironment and tumor therapies.
Zhang Z, Li X, Wang Y, Wei Y, et al · · 2023 · cited 55× · PMID 36932407 · DOI 10.1186/s13045-023-01407-7
Verify or expand the search:
- PubMed search for NCT04810611
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MBG453
Trials testing the same drug.
- NCT04878432 — STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS · Phase 2 · terminated
- NCT04823624 — MBG453 in Lower Risk MDS · Phase 2 · terminated
- NCT04283526 — Study of Select Combinations in Adults With Myelofibrosis · Phase 1 · withdrawn
- NCT04150029 — A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy · Phase 2 · terminated
- NCT03940352 — HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplast · Phase 1 · 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.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- 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 NCT04810611 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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: 10 October 2025
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/NCT04810611.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing