Primary Plasma Cell LeukemiaPhase 2CAREMM-014NCT07903623
QLS4131 Plus Isatuximab in Newly Diagnosed Primary Plasma Cell Leukemia
A Phase 2 study testing QLS4131 and Isatuximab in people with Primary Plasma Cell Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether QLS4131, a BCMA/GPRC5D/CD3 trispecific antibody, can improve treatment outcomes when combined with isatuximab in adults with newly diagnosed primary plasma cell leukemia (pPCL). The study will also evaluate the safety of this treatment combination. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Plasma Cell Leukemia
- What is being tested?
- QLS4131 and Isatuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2026to 30 Dec 2031
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must understand the study requirements and voluntarily provide written informed consent.
- Age between 18 and 75 years.
- Newly diagnosed primary plasma cell leukemia (pPCL) according to International Myeloma Working Group (IMWG) criteria, defined as malignant plasma cells accounting for ≥5% of circulating leukocytes on a peripheral blood smear or an absolute circulating malignant plasma cell count >2 × 10^9/L. Patients who have received no more than one cycle of prior anti-myeloma therapy are eligible.
- Measurable disease meeting at least one of the following criteria:
- Serum M-protein ≥10 g/L by serum protein electrophoresis (SPEP). For IgA- or IgD-type disease, quantitative IgA or IgD levels may be used.
- Urinary M-protein ≥200 mg/24 hours.
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- If serum and urine M-protein levels do not meet these criteria, an abnormal serum free light chain (FLC) ratio (normal range: 0.26-1.65) with an involved serum FLC level ≥100 mg/L.
- Adequate hepatic function, defined as total bilirubin <1.5 × the upper limit of normal (ULN), except for patients with Gilbert syndrome, for whom total bilirubin must be <3 × ULN; and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN.
- Creatinine clearance ≥30 mL/min, calculated using the Cockcroft-Gault formula.
- Hematologic parameters within seven days before screening assessment meeting the following criteria: white blood cell count ≥1.5 × 10^9/L, absolute neutrophil count ≥1.0 × 10^9/L, hemoglobin ≥70 g/L, and platelet count ≥50 × 10^9/L; or considered eligible by the investigator based on the clinical circumstances.
- For patients receiving hematopoietic growth factor support, including erythropoietin, G-CSF, GM-CSF, thrombopoietin receptor agonists, or other platelet-stimulating agents, at least two weeks must elapse between the last administration and screening assessment.
- For patients receiving blood product transfusions, at least two weeks must elapse between the last red blood cell transfusion and screening hemoglobin assessment, and at least one week between the last platelet transfusion and screening platelet assessment.
- Participants must be able to receive the recommended prophylactic anticoagulation therapy.
- Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use effective contraception from the time of informed consent throughout study treatment and for three months after the last dose of study treatment. Male participants, including those who have undergone vasectomy, must agree to use condoms during sexual intercourse with women of childbearing potential and must have no intention of fathering a child during the same period.
Who cannot join
- Diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance, Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or secondary plasma cell leukemia.
- Central nervous system involvement or clinical evidence of meningeal involvement.
- Known intolerance, hypersensitivity, or contraindication to QLS4131 or isatuximab.
- Severe or uncontrolled cardiovascular disease, including unstable angina, symptomatic congestive heart failure, myocardial infarction within six months before enrollment, severe uncontrolled arrhythmia, or other cardiovascular or cerebrovascular conditions considered unsuitable for participation by the investigator.
- Active infections, including HIV infection, active hepatitis B (positive HBV DNA), active hepatitis C (positive HCV RNA), active or latent syphilis infection (positive Treponema pallidum antibody), active pulmonary tuberculosis indicated by chest imaging or other relevant tests within three months before or during screening, or other infections considered unsuitable for participation by the investigator.
- Concurrent malignancy or serious concomitant disease that, in the investigator's opinion, may compromise participant safety or interfere with study completion.
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- Pregnant or breastfeeding women.
- Life expectancy of less than six months.
- Active gastrointestinal disorders that impair the ability to swallow tablets or may interfere with the absorption of study medications.
- Major surgery requiring general anesthesia within two weeks before enrollment, incomplete recovery from major surgery, or planned major surgery during study participation. Kyphoplasty or vertebroplasty is not considered major surgery. Procedures under local anesthesia are permitted.
- Receipt of a live attenuated vaccine within four weeks before the first administration of study treatment.
- Active severe psychiatric illness, medical condition, or other circumstances that, in the investigator's judgment, may interfere with treatment, protocol compliance, or the ability to provide informed consent.
- Inability or unwillingness to provide written informed consent.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000
Gang An, +0086 13502181109, angang@ihcams.ac.cn
About this study
Official title: A Prospective, Single-Arm, Single-Center Clinical Study of QLS4131 Combined With Isatuximab in Patients With Newly Diagnosed Primary Plasma Cell Leukemia
The goal of this clinical trial is to learn whether QLS4131, a BCMA/GPRC5D/CD3 trispecific antibody, can improve treatment outcomes when combined with isatuximab in adults with newly diagnosed primary plasma cell leukemia (pPCL). The study will also evaluate the safety of this treatment combination.
The main questions it aims to answer are:
Read more
- How many participants achieve measurable residual disease (MRD) negativity after 9 treatment cycles?
- What side effects occur during treatment with QLS4131 combined with isatuximab?
- How many participants respond to treatment, and how many achieve a complete response?
- How many participants achieve sustained MRD negativity?
- How long do participants remain free from disease progression, and how long do they survive after starting treatment?
All participants will receive the study treatment. There is no comparison group in this study.
Participants will:
- Receive QLS4131 by subcutaneous injection together with intravenous isatuximab in 28-day treatment cycles.
- Undergo regular blood tests, bone marrow examinations, and disease assessments to monitor treatment response and safety.
- Undergo peripheral blood stem cell mobilization and collection after the first 3 treatment cycles, if appropriate.
- Be monitored throughout the study for side effects, including adverse events and serious adverse events.
- Conditions
- Primary Plasma Cell Leukemia
- Being tested
- QLS4131, Isatuximab
- Keywords
- BCMA/GPRC5D/CD3 trispecific antibody, QLS4131, Primary plasma cell leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS4131Drug
QLS4131 is administered subcutaneously (SC) using a step-up dosing regimen, followed by a target dose of 12 mg. During Cycle 1, QLS4131 is administered every 2 weeks; from Cycle 2 through Cycle 18, it is administered every 4 weeks.
IsatuximabDrug
Isatuximab is administered intravenously (IV) at 10 mg/kg. It is given weekly during Cycle 1, every 2 weeks during Cycles 2-12, and every 4 weeks during Cycles 13-18.
| Study group | Role | What they receive |
|---|---|---|
| QLS4131 Plus Isatuximab | Experimental | Participants will receive QLS4131 in combination with isatuximab for up to 18 cycles, with each cycle lasting 28 days. Receives: Drug: QLS4131; Drug: Isatuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal residual disease (MRD) negative rate
Measured: After 9 cycles (each cycle is 28 days)
Secondary outcomes (6)
Incidence and severity of adverse events (AEs)
Measured: From the first dose of QLS4131 through 30 days after the last dose of QLS4131, up to approximately 18 months
Duration of MRD negativity
Measured: From the date of first documented MRD negativity until disease progression, death, or end of follow-up, whichever occurs first, assessed up to approximately 36 months.
Overall Response Rate (ORR)
Measured: Up to 18 treatment cycles, each cycle is 28 days
Complete Response Rate (CRR)
Measured: Up to 18 treatment cycles, each cycle is 28 days
Progression-free survival (PFS)
Measured: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, up to approximately 36 months.
Overall survival (OS)
Measured: From the first dose of study treatment until death from any cause, up to approximately 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start25 Oct 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Plasma Cell LeukemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903623
- Sponsor's protocol ID
- IIT2026112
- Acronym
- CAREMM-014
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Single-Center Clinical Study of QLS4131 Combined With Isatuximab in Patients With Newly Diagnosed Primary Plasma Cell Leukemia
- ClinicalTrials.gov ID
- NCT07903623
- Acronym / sponsor ID
- CAREMM-014 / IIT2026112
- Conditions
- Primary Plasma Cell Leukemia
- Keywords
- BCMA/GPRC5D/CD3 trispecific antibody, QLS4131, Primary plasma cell leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 29 Oct 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 trial is to learn whether QLS4131, a BCMA/GPRC5D/CD3 trispecific antibody, can improve treatment outcomes when combined with isatuximab in adults with newly diagnosed primary plasma cell leukemia (pPCL). The study will also evaluate the safety of this treatment combination.
The main questions it aims to answer are:
- How many participants achieve measurable residual disease (MRD) negativity after 9 treatment cycles?
- What side effects occur during treatment with QLS4131 combined with isatuximab?
- How many participants respond to treatment, and how many achieve a complete response?
- How many participants achieve sustained MRD negativity?
- How long do participants remain free from disease progression, and how long do they survive after starting treatment?
All participants will receive the study treatment. There is no comparison group in this study.
Participants will:
- Receive QLS4131 by subcutaneous injection together with intravenous isatuximab in 28-day treatment cycles.
- Undergo regular blood tests, bone marrow examinations, and disease assessments to monitor treatment response and safety.
- Undergo peripheral blood stem cell mobilization and collection after the first 3 treatment cycles, if appropriate.
- Be monitored throughout the study for side effects, including adverse events and serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS4131 Plus Isatuximab | Experimental | Drug: QLS4131, Drug: IsatuximabParticipants will receive QLS4131 in combination with isatuximab for up to 18 cycles, with each cycle lasting 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants must understand the study requirements and voluntarily provide written informed consent.
- Age between 18 and 75 years.
- Newly diagnosed primary plasma cell leukemia (pPCL) according to International Myeloma Working Group (IMWG) criteria, defined as malignant plasma cells accounting for ≥5% of circulating leukocytes on a peripheral blood smear or an absolute circulating malignant plasma cell count >2 × 10^9/L. Patients who have received no more than one cycle of prior anti-myeloma therapy are eligible.
- Measurable disease meeting at least one of the following criteria:
- Adequate hepatic function, defined as total bilirubin <1.5 × the upper limit of normal (ULN), except for patients with Gilbert syndrome, for whom total bilirubin must be <3 × ULN; and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN.
Key exclusion criteria (14 listed)
- Diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance, Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or secondary plasma cell leukemia.
- Central nervous system involvement or clinical evidence of meningeal involvement.
- Known intolerance, hypersensitivity, or contraindication to QLS4131 or isatuximab.
- Severe or uncontrolled cardiovascular disease, including unstable angina, symptomatic congestive heart failure, myocardial infarction within six months before enrollment, severe uncontrolled arrhythmia, or other cardiovascular or cerebrovascular conditions considered unsuitable for participation by the investigator.
- Active infections, including HIV infection, active hepatitis B (positive HBV DNA), active hepatitis C (positive HCV RNA), active or latent syphilis infection (positive Treponema pallidum antibody), active pulmonary tuberculosis indicated by chest imaging or other relevant tests within three months before or during screening, or other infections considered unsuitable for participation by the investigator.
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 |
|---|---|---|
| QLS4131QLS4131 is administered subcutaneously (SC) using a step-up dosing regimen, followed by a target dose of 12 mg. During Cycle 1, QLS4131 is administered every 2 weeks; from Cycle 2 through Cycle 18, it is administered every 4 weeks. | Drug | QLS4131 Plus Isatuximab |
| IsatuximabIsatuximab is administered intravenously (IV) at 10 mg/kg. It is given weekly during Cycle 1, every 2 weeks during Cycles 2-12, and every 4 weeks during Cycles 13-18. | Drug | QLS4131 Plus Isatuximab |
Primary outcome
Minimal residual disease (MRD) negative rate
Time frame: After 9 cycles (each cycle is 28 days)
6 secondary outcomes
Incidence and severity of adverse events (AEs)
Time frame: From the first dose of QLS4131 through 30 days after the last dose of QLS4131, up to approximately 18 months
Duration of MRD negativity
Time frame: From the date of first documented MRD negativity until disease progression, death, or end of follow-up, whichever occurs first, assessed up to approximately 36 months.
Overall Response Rate (ORR)
Time frame: Up to 18 treatment cycles, each cycle is 28 days
Complete Response Rate (CRR)
Time frame: Up to 18 treatment cycles, each cycle is 28 days
Progression-free survival (PFS)
Time frame: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, up to approximately 36 months.
Overall survival (OS)
Time frame: From the first dose of study treatment until death from any cause, up to approximately 36 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 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QLS4131 and Isatuximab in people with Primary Plasma Cell Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 14 inclusion and 14 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 29 Oct 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 China. 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 phase mean?
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 Gang An (+86 13502181109, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal residual disease (MRD) negative rate (time frame: After 9 cycles (each cycle is 28 days)). 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 29 Oct 2026.