NCT06234904

Study of IBR733 Cell Injection in Acute Myeloid Leukemia

An Open-label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR733 Cell Injection in Acute Myeloid Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Imbioray (Hangzhou) Biomedicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label clinical study: phase Ia is the dose-escalation part, and phase Ib is the dose-expansion part. The phase Ia study is to evaluate the safety, tolerability, recommended phase II dose, pharmacokinetics, immunogenicity and preliminary efficacy of IBR733 cell injection in relapsed/refractory acute myeloid leukemia (AML).

Detailed description

Phase Ia is the dose escalation part which adopts the "3+3" dose escalation design protocol. The dose is respectively 5.0×10\^9 cells, 7.5×10\^9 cells and 10.0×10\^9 cells. 3-6 subjects will be enrolled at every dose level. Subjects who have signed the Informed Consent Form (ICF) will be reviewed for inclusion/exclusion criteria (this process is called "screening"), and eligible subjects will be treated with IBR733 cell injection after lymphodepletion therapy. The administration of IBR733 cell injection is performed on day 1 and day 8 of each cycle (21 days). The first and second subjects in the same group shall be enrolled at an interval of at least 21 days, for the purpose of ensuring their safety.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	IBR733 Cell Injection	The minimum initial dose is 5.0×10\^9 cells and then escalate to 7.5×10\^9 cells and 10.0×10\^9 cells. Every 21 days is one cycle, and intravenous infusion is performed on day 1 and day 8 of each cycle.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-02-01
• Completion: 2025-08-01
• First posted: 2024-01-31
• Last updated: 2024-01-31

Locations

1 site across 1 country: China