Study of HuL001 in Relapsed/Refractory Multiple Myeloma Patients

NCT07210047 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: HuL001-CT-102
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Myeloma responses

  Myeloma responses as assessed by the investigator according to the IMWG criteria

  From enrollment to the end of treatment at 8 months

Secondary Outcomes (7)

• Safety parameters

  From enrollment to the end of treatment at 8 months

• PK parameter: Cmax

  From enrollment to the end of treatment at 8 months

• PK parameter: Tmax

  From enrollment to the end of treatment at 8 months

• PK parameter: AUCtau

  From enrollment to the end of treatment at 8 months

• PK parameter: AUCinf

  From enrollment to the end of treatment at 8 months

Study Arms (3)

Dose escalation Cohort 1

ACTIVE COMPARATOR

HuL001, Lenalidomide and Dexamethasone

Biological: HuL001-10 mg/kg; Drug: Lenalidomide and Dexamethasone

Dose escalation Cohort 2

ACTIVE COMPARATOR

HuL001, Lenalidomide and Dexamethasone

Biological: HuL001-15 mg/kg; Drug: Lenalidomide and Dexamethasone

Dose expansion Cohort 3

ACTIVE COMPARATOR

HuL001, Lenalidomide and Dexamethasone

Biological: HuL001-10 mg/kg; Biological: HuL001-15 mg/kg; Drug: Lenalidomide and Dexamethasone

Interventions

HuL001-10 mg/kg BIOLOGICAL

Anti-ENO1 monoclonal antibody

Also known as: Anti-ENO1 monoclonal antibody

Dose escalation Cohort 1; Dose expansion Cohort 3

HuL001-15 mg/kg BIOLOGICAL

Anti-ENO1 monoclonal antibody

Dose escalation Cohort 2; Dose expansion Cohort 3

Lenalidomide and Dexamethasone DRUG

Lenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM)

Dose escalation Cohort 1; Dose escalation Cohort 2; Dose expansion Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18 (inclusive) or older.
• Confirmed diagnosis of RRMM according to the IMWG guidelines (International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma, 2016).
• Subjects must have one or more of the following measurable disease criteria:
• Serum M-protein level ≥ 0.5 g/dL.
• Urine M-protein level ≥ 200 mg/24 hours.
• Light chain MM without measurable M-protein in the serum or urine: Serum immunoglobulin free light chain ≥ 10 mg/dL (local lab) and abnormal serum immunoglobulin kappa lambda free light chain ratio (per normal ranges of local lab).
• Subjects have disease progression on, refractory to, or intolerant to at least 3 prior lines of anti-myeloma therapies or 2 prior lines of therapies with three different drugs, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory drug, and are refractory to at least one of these drugs, or who are unwilling to receive or ineligible for other standard therapies according to local medical practice.
• There must be a time interval ≥ 3 months between the prior hematopoietic cell transplantation (HCT, counted as 1 prior line of therapy) and the first dose of HuL001.
• All toxicities associated with the prior anti-myeloma therapy have recovered to Grade 1 or baseline at the screening.
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
• Life expectancy ≥ 6 months in the opinion of the investigator.
• Adequate organ functions are defined as follows.
• Hemoglobin ≥ 8.5 g/dL.
• White blood cell (WBC) count ≥ 2.5 x 103/μL.
• Neutrophil count ≥ 1.5 × 103/μL.

You may not qualify if:

• Suspected or known contraindication or intolerant reaction to lenalidomide and/or dexamethasone.
• Suspected or known hypersensitivity (including allergy) to any of the components of the HuL001, lenalidomide, or dexamethasone.
• Previous history of anaphylaxis and severe allergic reaction, generation of neutralizing antibodies, or hypersensitivity to albumin or a protein-based therapeutic, or any other mAb.
• Planning to receive the HCT during the study period (approximately 6 months following the first dose of HuL001).
• Active graft versus host diseases (GvHD) following the prior HCT.
• Will be on digoxin therapy throughout the study period.
• Presence of multiple primary cancers with the exception of carcinoma in situ and skin cancers after curative surgery.
• Central nervous system (CNS) or meningeal involvement of MM by clinical signs or imaging studies.
• Significant infections requiring systemic treatment within 1 month prior to the first dose of HuL001.
• History of active tuberculosis in line with local medical practice.
• Major surgery within 4 weeks prior to the first dose of HuL001. Subjects should be fully recovered from any surgically related complications.
• Receipt of radiation therapy or systemic anti-MM treatments within 2 weeks prior to the first dose of HuL001.
• Receipt of any live or live attenuated vaccine (e.g., varicella, pneumococcus) within 4 weeks prior to the first dose of HuL001 or planning to receive live vaccine during the study period. Seasonal flu and COVID-19 vaccines not containing live virus are permitted.
• Any known active gastrointestinal dysfunction interfering with subject's ability to swallow tablets or any known active gastrointestinal dysfunction that could interfere with absorption of study drugs as judged by the investigator.
• Myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the screening visit.

Sponsors & Collaborators

• HuniLife Biotechnology, Inc.: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Maisie Huang, PhD

  HuniLife Biotechnology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 7, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)