Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.
TerminatedPhase 1, PHASE2Results postedLast updated 16 October 2025
What this trial tests
Phase 1, PHASE2 trial testing Sabatolimab in Acute Myeloid Leukemia in 24 participants. Terminated before completion.
Adults 12 to 99, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of Dose Limiting Toxicities (Safety Run-in in Adult Sabatolimab 400mg & 800mg Only)Primary· From Cycle 1 Day 1 to end of Cycle 2; Cycle =28 Days
Assessment of tolerability of sabatolimab in adults and adolescents in the post allogenic stem cell transplantation setting. This was determined by the number of participants with at least one event - All grades. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value considered by the Investigator to be at least possibly related to sabatolimab as a single contributor that occurs during the DLT observation period and meets the severity criteria as per protocol.
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
0
Sabatolimab 800mg Mono Adults
1
Percentage of Adult Subjects With Absence of Hematologic Relapse Per Investigator Assessment (Safety Run-in and Expansion)Primary· From Cycle 1 Day 1 to end of Cycle 6; Cycle = 28 Days
The percentage of adult participants for whom no evidence of hematologic relapse (no evidence of bone marrow blasts ≥5%, no evidence of reappearance of blasts in the blood; no evidence of development of extramedullary disease) has been documented after 6 cycles of study treatment or earlier discontinuation at the recommended dose of sabatolimab 800 mg.
Group
Value
95% CI
Sabatolimab 800mg Mono Adults
36.4
10.9 – 69.2
Rate of Dose Limiting Toxicities (Safety Confirmation in Adolescent Cohort Only)Primary· From Cycle 1 Day 1 to end of Cycle 2; Cycle =28 Days
Assessment of tolerability of sabatolimab in adolescent participants in the post allogeneic stem cell transplantation setting. This was determined by the number of participants with at least one event - All grades. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value considered by the Investigator to be at least possibly related to sabatolimab as a single contributor that occurs during the DLT observation period and meets the severity criteria as per protocol.
Group
Value
95% CI
Sabatolimab 800mg Mono Adolescent
0
Incidence of Grade III or IV Acute Graft Versus Host Disease (aGvHD)Secondary· From start of treatment to up to 36 months from last patient first treatment.
Assessment of the treatment emergent grade III or IV aGvHD. Acute GvHD: Grade IV acute GvHD, Stage ≥3 lower GI acute GvHD (consistent with Grade III acute GvHD) or Stage ≥3 liver acute GvHD (consistent with Grade III GvHD).
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
0
Sabatolimab 800mg Mono Adults
0
Sabatolimab 800mg + Azacitidine Adults
0
Sabatolimab 800mg Mono Adolescent
0
Incidence of Moderate to Severe Chronic GVHD (cGvHD)Secondary· From start of treatment to up to 36 months from last patient first treatment.
Assessment of the treatment emergent moderate or severe cGvHD. Chronic GvHD: Moderate chronic GvHD of the lungs, Severe chronic GvHD.
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
0
Sabatolimab 800mg Mono Adults
1
Sabatolimab 800mg + Azacitidine Adults
0
Sabatolimab 800mg Mono Adolescent
0
Peak of Serum Concentration (Cmax) SabatolimabSecondary· Cycle 1 Day 5 (end of infusion) and Cycle 3 Day 1 or Day 5 (end of infusion) and Cycle 24 Day 1 (end of infusion); Cycle =28 Days
Cmax is the maximal serum concentration of sabatolimab.
Cycle 1 Day 5 at 2 hours (hr) (end of infusion)
Group
Value
95% CI
Sabatolimab 800mg + Azacitidine Adults
256
± 0.0
Cycle 3 Day 1 at 2 hr (end of infusion)
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
137
± 52.7
Sabatolimab 800mg Mono Adults
304
± 31.4
Cycle 3 Day 5 at 2 hr (end of infusion)
Group
Value
95% CI
Sabatolimab 800mg + Azacitidine Adults
315
± 0.0
Cycle 24 Day 1 at 2 hr (end of infusion)
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
163
± 23.7
Trough Serum Concentration of (Cmin) SabatolimabSecondary· Adult cohorts: Pre-dose on Day 1 (safety run-in) or Day 5 (expansion) of Cycle 1, 3, 6 and 24 (safety run-in only); Adolescent cohort: Pre-dose on Day 1 of Cycle 1, 2, 3 and 6; Cycle = 28 Days
Cmin is the concentration of sabatolimab prior to next dosing or after end of treatment.
0-hour (hr) Pre-dose at Cycle 1 Day 1
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
0.00
± 0.0
Sabatolimab 800mg Mono Adults
0.00
± 0.0
Sabatolimab 800mg Mono Adolescent
0.00
± 0.0
0 hr (pre-dose) at Cycle 1 Day 5
Group
Value
95% CI
Sabatolimab 800mg + Azacitidine Adults
0.00
± 0.0
0 hr (pre-dose) at Cycle 2 Day 1
Group
Value
95% CI
Sabatolimab 800mg Mono Adolescent
70.7
± 0.0
0 hr (pre-dose) at Cycle 3 Day 1
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
40.4
± 20.2
Sabatolimab 800mg Mono Adults
70.7
± 47.5
Sabatolimab 800mg Mono Adolescent
129
± 0.0
0 hr (pre-dose) at Cycle 3 Day 5
Group
Value
95% CI
Sabatolimab 800mg + Azacitidine Adults
42.9
± 0.0
0 hr (pre-dose) at Cycle 6 Day 1
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
46.4
± 66.4
Sabatolimab 800mg Mono Adults
99.8
± 52.1
Sabatolimab 800mg Mono Adolescent
219
± 0.0
0 hr (pre-dose) at Cycle 6 Day 5
Group
Value
95% CI
Sabatolimab 800mg + Azacitidine Adults
71.9
± 0.0
0 hr (pre-dose) at Cycle 24 Day 1
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
49.7
± 44.1
Graft Versus Host Disease (GvHD)-Free/Relapse-free Survival (GRFS)Secondary· From start of treatment to up to 36 months from last patient first treatment
Time from start of treatment to the date of first documented occurrence or worsening of treatment emergent grade III or IV aGvHD or moderate to severe cGvHD requiring initiation of systemic treatment, morphologic/hematologic relapse, or death due to any cause, whichever occurs first
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
NA
NA – NA
Sabatolimab 800mg Mono Adults
NA
NA – NA
Sabatolimab 800mg + Azacitidine Adults
NA
NA – NA
Sabatolimab 800mg Mono Adolescent
NA
NA – NA
Relapse-free Survival (RFS)Secondary· From start of treatment to up to 36 months from last patient first treatment
Time from start of treatment to the date of first documented hematologic relapse or death due to any cause, whichever occurs first.
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
2.56
0.95 – NA
Sabatolimab 800mg Mono Adults
6.74
0.95 – NA
Sabatolimab 800mg + Azacitidine Adults
NA
NA – NA
Sabatolimab 800mg Mono Adolescent
7.16
NA – NA
Percentage of Participants With Measurable Residual Disease (MRD) Positive at Baseline Who Become MRD NegativeSecondary· From start of treatment until end of Cycle 6 (Cycle = 28 Days)
Percentage of participants with centrally confirmed MRD+ status at baseline converting to MRD- within the first 6 cycles of study treatment.
Group
Value
95% CI
Sabatolimab 400mg Mono Adults
0
0.0 – 30.8
Sabatolimab 800mg Mono Adults
0
0.0 – 28.5
Sabatolimab 800mg + Azacitidine Adults
0
0.0 – 84.2
Sabatolimab 800mg Mono Adolescent
0
0.0 – 97.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary purpose of this study was to test the hypothesis that preemptive treatment with sabatolimab, alone or in combination with azacitidine, when administered to participants with Acute myeloid leukemia (AML)/secondary AML who were in complete remission with positive measurable residual disease post-allogeneic hematopoietic stem cell transplantation (Minimal residual disease (MRD)+ post- Allogeneic hematopoietic stem cell transplantation (aHSCT)), could enhance the graft versus leukemia (GvL) response and prevent or delay hematologic relapse without an unacceptable level of treatment-emergent toxicities, including clinically significant acute and/or chronic graft-versus-host disease (GvHD) and immune-related adverse events
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05367401 — A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants
· Phase 1, PHASE2
· withdrawn
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
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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: 16 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/NCT04623216.