Multiple MyelomaPhase 1NCT07400744
A Study to Compare the PK , Safety, and Immunogenicity of QL2109 With Daratumumab in Male Subjects
A Phase 1 study testing QL2109 and Darzalex in people with Multiple Myeloma, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety and immunogenicity profiles of QL2109 and Darzalex following a single intravenous infusion in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- QL2109 and Darzalex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Oct 2026
- Phase
- Phase 1
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject should be a voluntary participant who has understood and signed the ICF.
- Age ≥ 18 years and ≤ 50 years, male (including the boundary values).
- Body weight ≥ 55 kilograms (kg), body mass index (BMI) = weight (kg) / height² (m²), with BMI within the range of 18-28 (including the boundary values).
- The subject agrees to use reliable contraceptive measures (such as abstinence, sterilization surgery, oral contraceptives, injectable contraceptives like medroxyprogesterone, or subcutaneous contraceptive implants) for themselves and their partner during the study and for 6 months after the trial drug infusion.
- No history of diseases, or any past medical history abnormalities are deemed clinically insignificant and judged by the study physician to have no impact on the trial.
Who cannot join
- Individuals with a history or current diagnosis of any clinically significant disease that may interfere with the trial results, including but not limited to disorders of the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, or metabolic systems, or those with clinically significant allergic reactions or allergic predisposition, angioedema, interstitial pneumonia, or acute respiratory distress syndrome.
- Individuals with acute, chronic, or potential infectious diseases within 1 month prior to dosing.
- Individuals with known immune system disorders (autoimmune diseases or immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia.
- Individuals with ocular diseases, including a history of intraocular surgery or laser eye surgery.
- Individuals with a history of localized cutaneous herpes zoster within 6 months prior to dosing.
- Individuals with disseminated cutaneous herpes zoster or herpes zoster involving the central nervous system, either currently or historically.
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- Individuals with a positive blood group antibody screening (indirect antiglobulin test).
- Individuals who have used monoclonal antibodies, cell therapies, or similar treatments within 6 months prior to dosing, or have previously received daratumumab or its analogues, or drugs targeting CD38.
- Individuals who have taken any medications (except premedication for QL2109 injection/DARZALEX®) within 2 weeks prior to dosing, including prescription drugs, over-the-counter drugs, and herbal medicines.
- Individuals with a history of drug or food allergies, including allergies to any drug or excipient used in the clinical trial.
- Individuals with a history of needle or blood phobia, or difficulty with venous blood collection (e.g., history of difficult blood draws or symptoms/signs indicating intolerance to venipuncture).
- Individuals who have donated blood or experienced blood loss totaling 200 mL or more within 3 months prior to dosing.
- Individuals who have participated in any other drug or medical device clinical trials within 3 months prior to dosing (or within 5 half-lives of the investigational drug if the half-life exceeds 3 months).
- Individuals who have undergone major surgery within 3 months prior to signing the informed consent form (ICF).
- Individuals who are positive for hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and/or hepatitis B core antibody (HBcAb); positive for hepatitis C virus antibody (HCV); positive for Treponema pallidum antibody; or positive for human immunodeficiency virus (HIV) antibody.
- Individuals with a history of drug abuse or substance dependence, or those with a positive urine drug screen.
- Individuals who have received live attenuated or live virus vaccines (e.g., Bacille Calmette-Guérin [BCG]) or viral vector vaccines within 12 months prior to the first dose, or plan to receive such vaccines within 12 months after dosing.
- Individuals who have received other vaccines, such as inactivated vaccines or recombinant subunit vaccines, within 1 month prior to the first dose, excluding the aforementioned live attenuated or live virus vaccines and viral vector vaccines.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity (Randomized, Double-blind, Single Dose, Parallel Controlled) of QL2109 With Daratumumab Injection in Healthy Chinese Male Subjects
The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety and immunogenicity profiles of QL2109 and Darzalex following a single intravenous infusion in healthy male subjects.
- Conditions
- Multiple Myeloma
- Being tested
- QL2109, Darzalex
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL2109Drug
Recombinant anti-CD38 fully human monoclonal antibody.
DarzalexDrug
Daratumumab injection
| Study group | Role | What they receive |
|---|---|---|
| QL2109 | Experimental | Not described Receives: Drug: QL2109 |
| Darzalex | Active comparator | Not described Receives: Drug: Darzalex |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞
Area under the serum concentration-time curve from time 0 to infinity
Measured: Up to Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400744
- Sponsor's protocol ID
- QL2109-102
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity (Randomized, Double-blind, Single Dose, Parallel Controlled) of QL2109 With Daratumumab Injection in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT07400744
- Acronym / sponsor ID
- QL2109-102
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Feb 2026 (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 study is to establish the comparability of the pharmacokinetics and similarity of the safety and immunogenicity profiles of QL2109 and Darzalex following a single intravenous infusion in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL2109 | Experimental | Drug: QL2109 |
| Darzalex | Active comparator | Drug: Darzalex |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject should be a voluntary participant who has understood and signed the ICF.
- Age ≥ 18 years and ≤ 50 years, male (including the boundary values).
- Body weight ≥ 55 kilograms (kg), body mass index (BMI) = weight (kg) / height² (m²), with BMI within the range of 18-28 (including the boundary values).
- The subject agrees to use reliable contraceptive measures (such as abstinence, sterilization surgery, oral contraceptives, injectable contraceptives like medroxyprogesterone, or subcutaneous contraceptive implants) for themselves and their partner during the study and for 6 months after the trial drug infusion.
- No history of diseases, or any past medical history abnormalities are deemed clinically insignificant and judged by the study physician to have no impact on the trial.
Key exclusion criteria (18 listed)
- Individuals with a history or current diagnosis of any clinically significant disease that may interfere with the trial results, including but not limited to disorders of the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, or metabolic systems, or those with clinically significant allergic reactions or allergic predisposition, angioedema, interstitial pneumonia, or acute respiratory distress syndrome.
- Individuals with acute, chronic, or potential infectious diseases within 1 month prior to dosing.
- Individuals with known immune system disorders (autoimmune diseases or immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia.
- Individuals with ocular diseases, including a history of intraocular surgery or laser eye surgery.
- Individuals with a history of localized cutaneous herpes zoster within 6 months prior to dosing.
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 |
|---|---|---|
| QL2109Recombinant anti-CD38 fully human monoclonal antibody. | Drug | QL2109 |
| DarzalexDaratumumab injection | Drug | Darzalex |
Primary outcome
AUC0-∞
Time frame: Up to Day 71
Area under the serum concentration-time curve from time 0 to infinity
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 10 Feb 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QL2109 and Darzalex in people with Multiple Myeloma, run by Qilu Pharmaceutical Co., Ltd..
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 5 inclusion and 18 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 Huan Zhou, Ph.D. (13665527160, zhouhuanbest@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-∞ (time frame: Up to Day 71). 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 10 Feb 2026.