Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT07173595
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07173595
Study Brief:
Protocol Section:
NCT07173595