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NCT Number: NCT07173595

A Phase I Study of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies

This is a single-arm, open-label, multicenter, dose-escalation, dose-expansion and efficacy-expansion phase I clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary antitumor activity of QLS2309 injection in patients with CD70+ relapsed/refractory hematologic malignancies.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100032, China

Location status: Recruiting

Location contact

Cuicui Cong

CONTACT

[email protected]

0088601088324516

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Subjects voluntarily participated and signed a written informed consent form
  • Age ≥ 18 years, male or female
  • ECOG performance status of 0-2
  • Expected life-expectancy ≥ 3 months
  • CD70+ relapsed/refractory hematologic malignancies
  • Adequate organ function prior to QLS2309 administration
  • Female patients with fertility must agree to the use of effective contraceptive methods during the study period and within 35 days of discontinuation of the trial drug.
  • Male patients whose sexual partners are women of childbearing age must agree to use condoms during the study period and within 35 days of discontinuation of the trial drug during sexual intercourse.

Exclusion criteria

  • Prior treatment with CD70-related antibodies, antibody-conjugated drugs (ADCs) or cell therapy products
  • Symptomatic central nervous system (CNS) involvement, leptomeningeal metastasis or spinal cord compression caused by metastasis
  • An active autoimmune diseases or known history of ≥ grade 3 irAE due to prior immunotherapy
  • Known history of other active malignant tumor within 3 years
  • Known history of chemotherapy, biological therapy, endocrine therapy, immunotherapy, monoclonal antibodies, etc. within 4 weeks
  • Known history of active hepatitis B/C infection, HIV infection, Treponema pallidum infection

Treatment and study plan

QLS2309

Drug

initial dose - MTD; QW; intravenous infusion

Primary outcomes

  1. Dose-limiting toxicity(DLT)

    Time frame: 28 days

    To evaluate the safety and tolerability of QLS2309

  2. Recommended Phase Ib Dose (RPIbD)

    Time frame: up to 2 years

    The Safety Monitoring Committee (SMC) will select RP1bD based on the safety, tolerability, PK parameters, pharmacodynamics, preliminary effectiveness and other data of subjects in different dose groups

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaojun Huang, MD

CONTACT

[email protected]

01088316617

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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