Phase 1 dose escalation and expansion trial of the bispecific CD47 inhibitor and CD40 agonist Fc-fusion protein SL-172154 (SIRPα-Fc-CD40L) in patients with higher-risk myelodysplastic syndrome or acute myeloid leukemia.
Naval G Daver, Amer M Zeidan, Anthony S Stein et al.
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In 30 seconds
This Phase I clinical trial evaluated the safety and efficacy of the bispecific CD47 inhibitor SL-172154 combined with azacitidine (AZA) in patients with higher-risk myelodysplastic syndrome (HR-MDS) or acute myeloid leukemia (AML). Among 81 enrolled patients, complete remission (CR) was achieved in 43% of HR-MDS and 29% of TP53 mutant AML patients, with a median overall survival of 11.0 months for HR-MDS and 11.7 months for TP53m AML.
Key findings
- Complete remission (CR) was achieved in 10 of 24 (43%) HR-MDS patients.
- Complete remission (CR) was achieved in six of 21 (29%) TP53m AML patients.
- Median overall survival (OS) was 11.0 months for HR-MDS and 11.7 months for TP53m AML.
- Infusion-related reactions were the most common toxicity, leading to dose limiting toxicity at 6 mg/kg.
Why it matters
The findings suggest that SL-172154 combined with AZA may offer a tolerable treatment option with promising remission rates for patients with higher-risk MDS and AML, particularly those with TP53 mutations, highlighting the need for further investigation.