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Not yet recruitingNCT07294300Updated Dec 19, 2025

A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological Malignancies

A Phase 1 interventional study of QLS2313 in Relapsed/Refractory Hematological Malignancies, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
124
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Relapsed/Refractory Hematological Malignancies
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In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's planned enrollment of 124 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    QLS2313

    Drug: QLS2313

Interventions

  • DrugQLS2313

    CD79b/CD3/CD20;first in human; subcutaneous injection

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: to 2 years

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Study locations

1 site
  • Shanghai Jiaotong University School of Medicine Ruijin Hospital
    Shanghai, Shanghai Municipality, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07294300
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 19, 2025
Start date
Jan 2026 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Dec 19, 2025

Study contacts

Weili Zhao, PhD
Contact
zwl_trial@163.com
15214370575

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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