Plasmablastic LymphomaPhase 2PBL-001NCT07921615
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
A Phase 2 study testing QLS4131 combined with Isa-V-CHOP in people with Plasmablastic Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This is a single-center, single-arm, open-label, phase II exploratory clinical study designed to evaluate the efficacy and safety of QLS4131 combined with the Isa-V-CHOP regimen in patients with treatment-naive, HIV-negative plasmablastic lymphoma. The study plans to enroll 10 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasmablastic Lymphoma
- What is being tested?
- QLS4131 combined with Isa-V-CHOP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understands and voluntarily signs the informed consent form (ICF);
- Age ≥18 years;
- Histopathologically confirmed plasmablastic lymphoma (PBL);
- Positive BCMA or GPRC5D expression: BCMA or GPRC5D expression on tumor cells confirmed by immunohistochemistry (IHC) or flow cytometry;
- Treatment-naive or having received no more than 1 cycle of prior systemic therapy (e.g., CHOP, EPOCH);
- Measurable disease (unless only bone marrow lesions are present), defined as at least one lesion with a longest diameter ≥1.5 cm as measured by CT or PET-CT;
Show all 10Show fewer
- ECOG performance status 0-2 (may be relaxed to 3 for elderly/frail patients if organ function permits);
- Liver function tests meeting the following criteria: total bilirubin ≤1.5× upper limit of normal (ULN), unless due to Gilbert's syndrome or of non-hepatic origin; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN (except for liver function impairment caused by tumor invasion);
- Renal function tests meeting the following criterion: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula);
- Blood routine tests within 14 days before the start of screening meeting the following criteria (except in patients with bone marrow involvement): absolute neutrophil count ≥1.0×10⁹/L and platelet count ≥75×10⁹/L; Expected life expectancy ≥2 months as judged by the investigator.
Who cannot join
- Diagnosis or treatment of a malignancy other than PBL within 1 year before enrollment (except for cases treated with surgery alone and considered cured);
- Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT) or CAR-T therapy;
- History of epilepsy or other central nervous system disorders;
- Other severe medical conditions that could affect the study (e.g., myocardial infarction within 6 months, uncontrolled diabetes, other severe cardiopulmonary diseases, etc.); the determination is at the investigator's discretion;
- Human immunodeficiency virus (HIV) infection;
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV-DNA or HCV-RNA above the upper limit of detection, with or without abnormal liver function. If a patient had active HBV infection at initial diagnosis and converted to inactive HBV infection after anti-HBV treatment, the patient may be enrolled in this study provided adequate anti-HBV therapy;
Show all 10Show fewer
- Pregnant or lactating women, or women of childbearing potential not using contraceptive measures;
- Major surgery (e.g., requiring general anesthesia) within 2 weeks before enrollment, or not expected to fully recover from surgery, or surgery planned during the planned study participation period. Note: subjects with planned surgical procedures under local anesthesia may participate in the study;
- Hypersensitivity to the drugs used;
- Any active severe psychiatric illness, medical illness, or other symptoms/conditions that, as judged by the investigator, may affect treatment, compliance, or the ability to provide informed consent.
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: A Single-Center, Single-Arm, Phase II Study Evaluating the Efficacy and Safety of QLS4131 in Combination With Isa-V-CHOP in Previously Untreated, HIV-Negative Patients With Plasmablastic Lymphoma (PBL)
This is a single-center, single-arm, open-label, phase II exploratory clinical study designed to evaluate the efficacy and safety of QLS4131 combined with the Isa-V-CHOP regimen in patients with treatment-naive, HIV-negative plasmablastic lymphoma. The study plans to enroll 10 patients.
The study consists of a screening period, a study treatment period, and a follow-up period. The screening period will last up to 21 days. The study treatment period will run from C1D1 to the end of Cycle 6, or until early termination due to disease progression, toxicity, or other reasons. After the end of study treatment, patients will be followed for 24 months.
- Conditions
- Plasmablastic Lymphoma
- Being tested
- QLS4131 combined with Isa-V-CHOP
- Keywords
- QLS4131, trispecific antibody
- Medical subject headings
- Plasmablastic Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS4131 combined with Isa-V-CHOPDrug
This study uses QLS4131 combined with the Isa-V-CHOP regimen for a total of 6 study cycles, with each cycle lasting 21 days. Vincristine and bortezomib will be administered at the adjusted doses and frequencies listed below; the doses will not be routinely escalated to the original high-intensity regimen merely because of good early tolerability. The treatment components are as follows:
QLS4131 + Isa + V-CHOP regimen
QLS4131: C1, 0.6 mg on d1, 3 mg on d4, 12 mg on d8; C2-6, 12 mg on d1
Isatuximab: 10 mg/kg in C1 on d1 and d8; C2-6, on d1
Bortezomib: 1.3 mg/m², SC, on d1 and d8
Cyclophosphamide: 750 mg/m², IV, on d1
Doxorubicin: 40-50 mg/m² or liposomal doxorubicin 30-40 mg/m², IV, on d1
Vincristine: 1.0 mg/m² (maximum dose 1.5 mg), IV, on d1
Prednisone: 60 mg/m² (maximum dose 100 mg), d1-5
| Study group | Role | What they receive |
|---|---|---|
| TsAb-treatment group | Experimental | Eligible patients who meet the inclusion/exclusion criteria will receive QLS4131 combined with the Isa-V-CHOP regimen after enrollment, with each cycle lasting 21 days; efficacy will be assessed after Cycles 2 and 4 and after completion of Cycle 6. After completing 6 cycles and the primary endpoint assessment, patients with advanced-stage disease (Ann Arbor stage III-IV) may receive autologous hematopoietic stem cell transplantation or QLS4131 monotherapy maintenance for 6 cycles; patients with limited-stage disease (stage I-II) may be considered for local radiotherapy. Receives: Drug: QLS4131 combined with Isa-V-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate (CRR)
Measured: 6 months
Secondary outcomes (1)
Overall response rate (ORR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion9 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmablastic LymphomaStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921615
- Sponsor's protocol ID
- IIT2026107
- Acronym
- PBL-001
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm, Phase II Study Evaluating the Efficacy and Safety of QLS4131 in Combination With Isa-V-CHOP in Previously Untreated, HIV-Negative Patients With Plasmablastic Lymphoma (PBL)
- ClinicalTrials.gov ID
- NCT07921615
- Acronym / sponsor ID
- PBL-001 / IIT2026107
- Conditions
- Plasmablastic Lymphoma
- Keywords
- QLS4131, trispecific antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 9 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 6 Nov 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.
This is a single-center, single-arm, open-label, phase II exploratory clinical study designed to evaluate the efficacy and safety of QLS4131 combined with the Isa-V-CHOP regimen in patients with treatment-naive, HIV-negative plasmablastic lymphoma. The study plans to enroll 10 patients.
The study consists of a screening period, a study treatment period, and a follow-up period. The screening period will last up to 21 days. The study treatment period will run from C1D1 to the end of Cycle 6, or until early termination due to disease progression, toxicity, or other reasons. After the end of study treatment, patients will be followed for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TsAb-treatment group | Experimental | Drug: QLS4131 combined with Isa-V-CHOPEligible patients who meet the inclusion/exclusion criteria will receive QLS4131 combined with the Isa-V-CHOP regimen after enrollment, with each cycle lasting 21 days; efficacy will be assessed after Cycles 2 and 4 and after completion of Cycle 6. After completing 6 cycles and the primary endpoint assessment, patients with advanced-stage disease (Ann Arbor stage III-IV) may receive autologous hematopoietic stem cell transplantation or QLS4131 monotherapy maintenance for 6 cycles; patients with limited-stage disease (stage I-II) may be considered for local radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Understands and voluntarily signs the informed consent form (ICF);
- Age ≥18 years;
- Histopathologically confirmed plasmablastic lymphoma (PBL);
- Positive BCMA or GPRC5D expression: BCMA or GPRC5D expression on tumor cells confirmed by immunohistochemistry (IHC) or flow cytometry;
- Treatment-naive or having received no more than 1 cycle of prior systemic therapy (e.g., CHOP, EPOCH);
Key exclusion criteria (10 listed)
- Diagnosis or treatment of a malignancy other than PBL within 1 year before enrollment (except for cases treated with surgery alone and considered cured);
- Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT) or CAR-T therapy;
- History of epilepsy or other central nervous system disorders;
- Other severe medical conditions that could affect the study (e.g., myocardial infarction within 6 months, uncontrolled diabetes, other severe cardiopulmonary diseases, etc.); the determination is at the investigator's discretion;
- Human immunodeficiency virus (HIV) infection;
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 |
|---|---|---|
| QLS4131 combined with Isa-V-CHOPThis study uses QLS4131 combined with the Isa-V-CHOP regimen for a total of 6 study cycles, with each cycle lasting 21 days. Vincristine and bortezomib will be administered at the adjusted doses and frequencies listed below; the doses will not be routinely escalated to the original high-intensity regimen merely because of good early tolerability. The treatment components are as follows: QLS4131 + Isa + V-CHOP regimen QLS4131: C1, 0.6 mg on d1, 3 mg on d4, 12 mg on d8; C2-6, 12 mg on d1 Isatuximab: 10 mg/kg in C1 on d1 and d8; C2-6, on d1 Bortezomib: 1.3 mg/m², SC, on d1 and d8 Cyclophosphamide: 750 mg/m², IV, on d1 Doxorubicin: 40-50 mg/m² or liposomal doxorubicin 30-40 mg/m², IV, on d1 Vincristine: 1.0 mg/m² (maximum dose 1.5 mg), IV, on d1 Prednisone: 60 mg/m² (maximum dose 100 mg), d1-5 | Drug | TsAb-treatment group |
Primary outcome
Complete response rate (CRR)
Time frame: 6 months
1 secondary outcome
Overall response rate (ORR)
Time frame: 6 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 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Plasmablastic Lymphoma
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
RecruitingEarly Phase 1
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Plasmablastic Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
Active, not recruitingPhase 2
Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
ALK-Positive Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma Activated B-Cell Type
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 2 study testing QLS4131 combined with Isa-V-CHOP in people with Plasmablastic Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, 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 10 inclusion and 10 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 6 Nov 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 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 (86-022-23909171, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (CRR) (time frame: 6 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 6 Nov 2026.