Multiple Myeloma RefractoryPhase 1/2NCT07210047
Study of HuL001 in Relapsed/Refractory Multiple Myeloma Patients
A Phase 1/2 study testing HuL001 and Lenalidomide/Dexamethasone in people with Multiple Myeloma Refractory, run by HuniLife Biotechnology, Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma Refractory
- What is being tested?
- HuL001 and Lenalidomide/Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Aug 2025to 31 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet ALL inclusion criteria will be included.
- 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.
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- 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.
- Platelet count ≥ 80 × 103/μL.
- Aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN).
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Total bilirubin ≤ 2 × ULN.
- Creatinine clearance (CrCl) ≥ 60 mL/min, calculated using Cockcroft-Gault formula.
- Notes:
- Subjects receiving hematopoietic growth factor support, e.g., erythropoietin, granulocyte-colony stimulating factor, platelet stimulator, etc. must have a 2-week interval between growth factor support and the screening evaluation. They may receive growth factor support after the DLT assessment period during the study.
- There must be at least a 2-week interval between the last red blood cell (RBC) transfusion and hemoglobin assessment at the screening and at least a 1-week interval between the last platelet transfusion and the platelet assessment at the screening. Subjects may receive RBC and platelet transfusion after the DLT assessment period during the study.
- Negative serology test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) infection. Note: If a subject with positive anti-HCV Ab, the subject must be with negative HCV RNA for enrollment. If a subject with positive HBsAg, the subject must be with undetectable HBV DNA for enrollment.
- Female subject with reproductive potential must have a negative result of serum pregnancy test at the screening visit and urine pregnancy test before each cycle of HuL001 administration.
- Female subject with reproductive potential and male subject with reproductive potential must agree to refrain from unprotected sex and use 2 methods of highly effective contraception with their partner (e.g., barrier contraceptives [male condom, female condom, or diaphragm plus spermicide], intrauterine device, hormonal methods [hormone shot or injection, implants, combination oral contraceptives, or patches]) for ≥ 6 months after the last dose of HuL001.
- Physically and mentally capable of participating in the study and willing to adhere to study procedures.
- Provision of signed informed consent.
Who cannot join
- Subjects who meet ANY exclusion criteria will be excluded.
- 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.
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- 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.
- Evidence or history of severe intercurrent medical conditions or clinically significant comorbidities that may interfere with optimal participation in the study or place the subject at increased risk of adverse events, including but not limited to psychiatric, ophthalmic, hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunologic, metabolic, urologic, dermatologic, neurologic, or allergic diseases, or other significant clinical findings within 3 months prior to the screening, as judged by the Investigator.
- Receipt of any investigational drug or device or participation in a clinical study within 28 days prior to the V2(C1D1).
- History of substance or alcohol abuse within 6 months prior to the screening visit.
- Female subjects who are pregnant, breastfeeding, or planning to be pregnant or breastfeeding during the screening and study period.
- Subject who is considered unfit to participate in the clinical study as assessed by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
Taipei
MIN-CHI HSU, Bachelor of Science in Nursing, minchishiu@gmail.com
YUAN-PIN YU, Doctor of Medicine
About this study
Official title: 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
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:
Read more
- To evaluate the safety and tolerability of HuL001 (in combination with Len/Dex).
- 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
- Being tested
- HuL001, Lenalidomide/Dexamethasone
- Keywords
- Relapsed/Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuL001Drug
Anti-ENO1 monoclonal antibody
Lenalidomide/DexamethasoneDrug
Lenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM)
| Study group | Role | What they receive |
|---|---|---|
| HuL001 with Lenalidomide/Dexamethasone | Experimental | (Phase 1b)Dose escalation phase: Two to three cohorts of escalating dose levels of HuL001 from 10mg/kg to 15 mg/kg.
(Phase2)Dose expansion phase: Single cohort at Recommended Phase 2 Dose (RP2D) of HuL001 with Lenalidomide/Dexamethasone . Receives: Drug: HuL001; Drug: Lenalidomide/Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myeloma responses, including sCR, CR, VGPR, PR, MR, SD, PD, clinical relapse, ORR, CBR, DoR, time to sCR, time to CR, time to VGPR, time to PR, time to MR, as assessed by the investigator according to the IMWG criteria.
Complete Response (CR): Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in the bone marrow.
Very Good Partial Response (VGPR): ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hours (or ≥ 90% reduction in serum free light chain difference if serum/urine M-proteins are unmeasurable).
Partial Response (PR): ≥ 50% reduction in serum M-protein and reduction in 24-hour urine M-protein by ≥ 90% (or to <200 mg/24 hours). If M-protein is unmeasurable, a ≥ 50% reduction in the difference between involved and uninvolved serum free light chains or bone marrow plasma cells.
Minimal Response (MR): 25% to 49% reduction in serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%.
Stable Disease (SD): Does not meet criteria for PR, VGPR, CR, or progressive disease (not changing significantly).
Progressive Disease (PD): Increase of >25% from lowest response value in M-protein, serum fr
Measured: From enrollment to the end of treatment at 8 months
Secondary outcomes (2)
Safety parameters, including occurrence, severity, and relationship of the TEAEs, as assessed by the NCI-CTCAE version 5.0 during the study period.
All AEs and toxicities are evaluated based on the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 5.0. The 5 general grades are Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, and Grade 5: Death (outcome of AE).
Measured: From enrollment to the end of treatment at 8 months
Immunogenicity
Immunogenicity: Anti-HuL001 antibodies (ADA).
Measured: From enrollment to the end of treatment at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start18 Aug 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma RefractoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HuniLife Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maisie Huang, PhD, Study director, HuniLife Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210047
- Sponsor's protocol ID
- HuL001-CT-102
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no current plans to prepare IPD for sharing due to resource limitations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07210047
- Acronym / sponsor ID
- HuL001-CT-102
- Conditions
- Multiple Myeloma Refractory
- Keywords
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- HuniLife Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the safety and tolerability of HuL001 (in combination with Len/Dex).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HuL001 with Lenalidomide/Dexamethasone | Experimental | Drug: HuL001, Drug: Lenalidomide/Dexamethasone(Phase 1b)Dose escalation phase: Two to three cohorts of escalating dose levels of HuL001 from 10mg/kg to 15 mg/kg. (Phase2)Dose expansion phase: Single cohort at Recommended Phase 2 Dose (RP2D) of HuL001 with Lenalidomide/Dexamethasone . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Subjects who meet ALL inclusion criteria will be included.
- 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:
- 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.
Key exclusion criteria (21 listed)
- Subjects who meet ANY exclusion criteria will be excluded.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HuL001Anti-ENO1 monoclonal antibody | Drug | HuL001 with Lenalidomide/Dexamethasone |
| Lenalidomide/DexamethasoneLenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM) | Drug | HuL001 with Lenalidomide/Dexamethasone |
Primary outcome
Myeloma responses, including sCR, CR, VGPR, PR, MR, SD, PD, clinical relapse, ORR, CBR, DoR, time to sCR, time to CR, time to VGPR, time to PR, time to MR, as assessed by the investigator according to the IMWG criteria.
Time frame: From enrollment to the end of treatment at 8 months
Complete Response (CR): Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in the bone marrow. Very Good Partial Response (VGPR): ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hours (or ≥ 90% reduction in serum free light chain difference if serum/urine M-proteins are unmeasurable). Partial Response (PR): ≥ 50% reduction in serum M-protein and reduction in 24-hour urine M-protein by ≥ 90% (or to <200 mg/24 hours). If M-protein is unmeasurable, a ≥ 50% reduction in the difference between involved and uninvolved serum free light chains or bone marrow plasma cells. Minimal Response (MR): 25% to 49% reduction in serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Stable Disease (SD): Does not meet criteria for PR, VGPR, CR, or progressive disease (not changing significantly). Progressive Disease (PD): Increase of >25% from lowest response value in M-protein, serum fr
2 secondary outcomes
Safety parameters, including occurrence, severity, and relationship of the TEAEs, as assessed by the NCI-CTCAE version 5.0 during the study period.
Time frame: From enrollment to the end of treatment at 8 months
Immunogenicity
Time frame: From enrollment to the end of treatment at 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. There are no current plans to prepare IPD for sharing due to resource limitations.
Related trials for Multiple Myeloma Refractory
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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
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A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
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Active, not recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maisie Huang, PhD study director
HuniLife Biotechnology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HuL001 and Lenalidomide/Dexamethasone in people with Multiple Myeloma Refractory, run by HuniLife Biotechnology, Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Chan, master (886-2-26579668, zoechan@hunilife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myeloma responses, including sCR, CR, VGPR, PR, MR, SD, PD, clinical relapse, ORR, CBR, DoR, time to sCR, time to CR, time to VGPR, time to PR, time to MR, as assessed by the investigator according to the IMWG criteria. (time frame: From enrollment to the end of treatment at 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.