NCT05622591

ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML

Dose Escalation Study to Evaluate the Safety and Tolerability of ELU001 in Pediatric Patients Who Have Relapsed and/or Refractory CBFA2T3::GLIS2 Positive Acute Myeloid Leukemia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Elucida Oncology · Industry
• Sex: All
• Age: 1 Month – 9 Years
• Healthy volunteers: Not accepted

Summary

This research study was planned to focus on a rare type of acute myeloid leukemia (with the subtype CBFA2T3::GLIS2 that overexpresses folate receptor alpha (FRα) (a protein on the surface of leukemia cells)) that has relapsed or is refractory. Relapse means the cancer has come back after treatment. Refractory means the cancer does not respond to treatment.

Detailed description

This study was planned as a Dose Escalation Safety Study to identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D). This study will also evaluate the tolerability of ELU001. ELU001 is not a drug approved by the FDA (Food and Drug Administration) yet.

Conditions

• Acute Myeloid Leukemia
• AML, Childhood
• Relapsed Pediatric AML
• Refractory Pediatric AML

Interventions

Type	Name	Description
DRUG	ELU001	Folic-acid functionalized C'Dot-Drug-Conjugate (FA-CDC)

Timeline

• Start date: 2024-06-07
• Primary completion: 2024-06-07
• Completion: 2024-06-07
• First posted: 2022-11-18
• Last updated: 2024-08-07

Regulatory

• FDA-regulated drug study