Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07173595

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

Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-01-02

186

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects voluntarily participated and signed a written informed consent form
  • Age 18 years or older, male or female
  • ECOG performance status of 0-2
  • Expected life expectancy of at least 3 months
  • Diagnosed with CD70-positive relapsed or refractory hematologic malignancies
  • Adequate organ function before receiving QLS2309
  • Female patients with fertility must agree to use effective contraception during the study and for 35 days after stopping the drug
  • Male patients with female partners of childbearing age must agree to use condoms during the study and for 35 days after stopping the drug
Not Eligible

You will not qualify if you...

  • Previous treatment with CD70-related antibodies, antibody-conjugated drugs, or cell therapy products
  • Symptomatic central nervous system involvement, leptomeningeal metastasis, or spinal cord compression caused by metastasis
  • Active autoimmune diseases or history of grade 3 or higher immune-related adverse events from prior immunotherapy
  • History of other active malignant tumors within the past 3 years
  • Received chemotherapy, biological therapy, endocrine therapy, immunotherapy, or monoclonal antibodies within the past 4 weeks
  • Known active hepatitis B or C infection, HIV infection, or Treponema pallidum infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100032

Actively Recruiting

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Research Team

X

Xiaojun Huang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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