NCT07185490

IASO104 for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Exploratory Clinical Study Protocol on the Safety and Efficacy of Fully Human BCMA-Targeted Chimeric Antigen Receptor Autologous T-Cell Injection (IASO104) for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, open-label, dose-exploration trial designed to evaluate the tolerability and safety of different doses of IASO104 in patients with relapsed/refractory plasma cell neoplasms, determine the recommended dose of IASO104, and assess its pharmacokinetic and pharmacodynamic characteristics. Additionally, the study will preliminarily observe the efficacy of the investigational drug in a small sample of subjects with relapsed/refractory multiple myeloma.

Detailed description

This study adopts a "3+3" dose-escalation design, with three predefined dose levels: 0.5×10⁶ CAR-T cells/kg, 1.0×10⁶ CAR-T cells/kg, and 3.0×10⁶ CAR-T cells/kg, administered as a single infusion.For each dose group, the first subject must be observed for at least 2 weeks after infusion before subsequent subjects can be treated. If stable biological activity or clinical benefit is observed at a lower dose level, the study may proceed with 1-2 expanded dose groups at lower levels after discussion between the investigator and sponsor, without requiring MTD determination.During the dose-escalation phase, 2-3 subjects will be enrolled per dose level, with the total number of subjects depending on the escalation progression (estimated 4-6 subjects in this phase). Treatment in the next dose group may only begin after all subjects in the current group have completed DLT assessment post-infusion.

Conditions

• Relapsed/Refractory Multiple Myeloma (RRMM)
• Plasma Cell Leukemia (PCL)

Interventions

Type	Name	Description
BIOLOGICAL	IASO104	IASO104 is a personalized, BCMA-targeted, genetically modified autologous T-cell immunotherapy product.

Timeline

• Start date: 2026-02-15
• Primary completion: 2027-08-15
• Completion: 2029-08-15
• First posted: 2025-09-22
• Last updated: 2026-01-20