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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07338604
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥ 18 years, regardless of gender.
* Expected survival time ≥ 3 months.
* ECOG performance status score of 0-1.
* Confirmed diagnosis of relapsed/refractory CD7-positive hematolymphoid malignancies at screening.
* Coagulation function, liver and kidney function, and cardiopulmonary function meeting the requirements.
* Ability to understand the trial and signed informed consent form.
Exclusion Criteria:
* A history of malignant tumors other than hematolymphoid malignancies within 5 years prior to screening, excluding carcinoma in situ.
* Positive results for virological tests or syphilis.
* Severe cardiac diseases.
* Unstable systemic diseases as determined by the investigator.
* Active or uncontrolled infections requiring systemic treatment within 7 days prior to screening, excluding mild urinary and reproductive system infections and upper respiratory tract infections.
* Pregnant or lactating women; female subjects planning to become pregnant within 2 years after cell infusion; or male subjects whose partners plan to become pregnant within 2 years after the subject's cell infusion.
* Subjects receiving systemic corticosteroid therapy within 7 days prior to screening, or those judged by the investigator to require long-term systemic corticosteroid therapy during the trial period, excluding inhaled or topical administration.
* Participation in other clinical studies within 1 month prior to screening.
* Evidence of central nervous system (CNS) involvement at screening, such as detection of tumor cells in cerebrospinal fluid (CSF) or imaging findings suggestive of CNS infiltration.
* Patients requiring long-term use of immunosuppressants as determined by the investigator at screening.
* A history of epilepsy or other central nervous system diseases.
* Patients with primary immunodeficiency diseases.
* Other circumstances deemed inappropriate for enrollment by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07338604
Study Brief:
Protocol Section:
NCT07338604