NCT07210047

Study of HuL001 in Relapsed/Refractory Multiple Myeloma Patients

A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of HuL001 in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

• Status: Enrolling By Invitation
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: HuniLife Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the antibody drug HuL001, combined with Lenalidomide/Dexamethasone works to treat Multiple Myeloma patients. It will also learn about the safety and tolerability of the therapeutic combination. The objectives of this study are: 1. To evaluate the safety and tolerability of HuL001 (in combination with Len/Dex). 2. To evaluate the efficacy of HuL001 (in combination with Len/Dex). Researchers will use the antibody drug HuL001, combined with Len/Dex, to see if this works for Multiple Myeloma therapy. Participants will: * Receive HuL001 antibody injections every 2 weeks * Take Lenalidomide for 21 consecutive days each month * Take Dexamethasone every 1 week * Visit the clinic on scheduled days for checkups and tests * Keep a diary of their symptoms and Myeloma responses.

Conditions

• Multiple Myeloma Refractory

Interventions

Type	Name	Description
BIOLOGICAL	HuL001-10 mg/kg	Anti-ENO1 monoclonal antibody
BIOLOGICAL	HuL001-15 mg/kg	Anti-ENO1 monoclonal antibody
DRUG	Lenalidomide and Dexamethasone	Lenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM)

Timeline

• Start date: 2025-08-18
• Primary completion: 2027-11-30
• Completion: 2028-01-31
• First posted: 2025-10-07
• Last updated: 2025-10-07

Locations

1 site across 1 country: Taiwan