QLS2309 injections for adults with CD70-positive relapsed or refractory blood cancers.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label, multicenter Phase I trial using dose-escalation followed by dose-expansion and efficacy-expansion cohorts to define tolerability, safety, pharmacokinetics and preliminary antitumor activity of QLS2309. Eligible participants are adults with relapsed or refractory hematologic malignancies that express CD70 and who meet performance status and organ-function requirements. The trial excludes patients with prior CD70-targeted therapies, symptomatic CNS involvement, or active autoimmune disease, among other criteria. Serial safety monitoring and pharmacokinetic sampling will be performed alongside tumor response assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaojun Huang, MD
• Email: xjhrm@medmail.com.cn
• Phone: 01088316617

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.