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

NCT ID: NCT07173595

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-05

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsed or Refractory Hematologic Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QLS2309

Group Type EXPERIMENTAL

QLS2309

Intervention Type DRUG

initial dose - MTD; QW; intravenous infusion

Interventions

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QLS2309

initial dose - MTD; QW; intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaojun Huang, MD

Role: CONTACT

01088316617

Facility Contacts

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Cuicui Cong

Role: primary

0088601088324516

Other Identifiers

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QLS2309-101

Identifier Type: -

Identifier Source: org_study_id

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