QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study (PBL-001)

November 2, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Understands and voluntarily signs the informed consent form (ICF);
  2. Age ≥18 years;
  3. Histopathologically confirmed plasmablastic lymphoma (PBL);
  4. Positive BCMA or GPRC5D expression: BCMA or GPRC5D expression on tumor cells confirmed by immunohistochemistry (IHC) or flow cytometry;
  5. Treatment-naive or having received no more than 1 cycle of prior systemic therapy (e.g., CHOP, EPOCH);
  6. 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;
  7. ECOG performance status 0-2 (may be relaxed to 3 for elderly/frail patients if organ function permits);
  8. 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);
  9. Renal function tests meeting the following criterion: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula);
  10. 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.

Exclusion Criteria:

  1. Diagnosis or treatment of a malignancy other than PBL within 1 year before enrollment (except for cases treated with surgery alone and considered cured);
  2. Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT) or CAR-T therapy;
  3. History of epilepsy or other central nervous system disorders;
  4. 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;
  5. Human immunodeficiency virus (HIV) infection;
  6. 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;
  7. Pregnant or lactating women, or women of childbearing potential not using contraceptive measures;
  8. 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;
  9. Hypersensitivity to the drugs used;
  10. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TsAb-treatment group

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.
Drug: QLS4131 combined with Isa-V-CHOP

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Complete response rate (CRR)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall response rate (ORR)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT2026107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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