Relapsed/Refractory Hematological MalignanciesPhase 1NCT07294300
A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological Malignancies
A Phase 1 study testing QLS2313 in people with Relapsed/Refractory Hematological Malignancies, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary antitumor activity of QLS2313 as a monotherapy in patients with relapsed/refractory hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Hematological Malignancies
- What is being tested?
- QLS2313
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Feb 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged ≥ 18 years；
- Patients with relapsed/refractory hematological malignancies, specifically patients with B-cell NHL or CLL/small lymphocytic lymphoma (SLL) as defined by the 2022 World Health Organization (WHO) classification, who are relapsed/refractory and have no standard of care available as judged by the investigator;
- Having a measurable disease defined by appropriate disease response criteria;
- Subjects with sufficient organ function prior to the first dose of the investigational drug
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1
Who cannot join
- Previous treatment with a CD79b/CD3/CD20 trispecific antibody；
- Known central nervous system (CNS) involvement；
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation/bone marrow transplantation；
- Treatment with autologous stem cell transplantation within 3 months;
- Prior genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T cells [CAR-T] and natural killer cells [CAR-NK]) within 3 months
- Presence of viral, bacterial or uncontrolled fungal infection requiring intravenous drug infusion within 1 week prior to the first dose
- Presence of chronic or acute active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV-5 test at screening indicating active infection (positive HBsAg and/or positive HBcAb) with HBV-DNA > ULN, or positive HCVAb and positive HCV-RNA, allowed for antiviral therapy.
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
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS2313 for Injection in Patients With Relapsed/Refractory Hematological Malignancies
This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary antitumor activity of QLS2313 as a monotherapy in patients with relapsed/refractory hematological malignancies.
- Being tested
- QLS2313
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS2313Drug
CD79b/CD3/CD20;first in human; subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| QLS2313 | Experimental | Not described Receives: Drug: QLS2313 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT, MTD, RPIbD, and RP2D
To evaluate the tolerability and safety of subcutaneously administered QLS2313 for Injection in patients with hematological malignancies, and to determine the MTD, RPIbD, and RP2D.
Measured: to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Hematological MalignanciesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 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
- NCT07294300
- Sponsor's protocol ID
- QLS2313-101
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS2313 for Injection in Patients With Relapsed/Refractory Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07294300
- Acronym / sponsor ID
- QLS2313-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 19 Dec 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.
This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary antitumor activity of QLS2313 as a monotherapy in patients with relapsed/refractory hematological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS2313 | Experimental | Drug: QLS2313 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females aged ≥ 18 years；
- Patients with relapsed/refractory hematological malignancies, specifically patients with B-cell NHL or CLL/small lymphocytic lymphoma (SLL) as defined by the 2022 World Health Organization (WHO) classification, who are relapsed/refractory and have no standard of care available as judged by the investigator;
- Having a measurable disease defined by appropriate disease response criteria;
- Subjects with sufficient organ function prior to the first dose of the investigational drug
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1
Key exclusion criteria (7 listed)
- Previous treatment with a CD79b/CD3/CD20 trispecific antibody；
- Known central nervous system (CNS) involvement；
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation/bone marrow transplantation；
- Treatment with autologous stem cell transplantation within 3 months;
- Prior genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T cells [CAR-T] and natural killer cells [CAR-NK]) within 3 months
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 |
|---|---|---|
| QLS2313CD79b/CD3/CD20;first in human; subcutaneous injection | Drug | QLS2313 |
Primary outcome
DLT, MTD, RPIbD, and RP2D
Time frame: to 2 years
To evaluate the tolerability and safety of subcutaneously administered QLS2313 for Injection in patients with hematological malignancies, and to determine the MTD, RPIbD, and RP2D.
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 19 Dec 2025.
- 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 1 study testing QLS2313 in people with Relapsed/Refractory Hematological Malignancies, run by Qilu Pharmaceutical Co., Ltd. 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 5 inclusion and 7 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 19 Dec 2025. 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 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 Weili Zhao, PhD (15214370575, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT, MTD, RPIbD, and RP2D (time frame: to 2 years). 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 19 Dec 2025.