New shot for tough blood cancers enters first human tests
NCT ID NCT07294300
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug called QLS2313 in 124 adults with blood cancers (like lymphoma or leukemia) that returned or didn't respond to standard treatments. The main goal is to check safety and find the right dose, not to cure the disease. Participants receive the drug as a shot under the skin.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 124 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males or females aged ≥ 18 years; 2. 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; 3. Having a measurable disease defined by appropriate disease response criteria; 4. Subjects with sufficient organ function prior to the first dose of the investigational drug 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1 Exclusion Criteria: 1. Previous treatment with a CD79b/CD3/CD20 trispecific antibody; 2. Known central nervous system (CNS) involvement; 3. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation/bone marrow transplantation; 4. Treatment with autologous stem cell transplantation within 3 months; 5. Prior genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T cells \[CAR-T\] and natural killer cells \[CAR-NK\]) within 3 months 6. Presence of viral, bacterial or uncontrolled fungal infection requiring intravenous drug infusion within 1 week prior to the first dose 7. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can engineered cells beat blood cancers that Won't quit?
- Can a new pill outsmart Treatment-Resistant blood cancer?
- Immune cells engineered to fight lymphoma enter human testing
- New combo therapy shows promise for tough lymphoma cases
- New cell therapy takes aim at Hard-to-Treat blood cancers
- New study aims to crack the code of treatment resistance in lymphoma