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 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07330895
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years, regardless of race.
2. Expected survival time exceeds 12 weeks.
3. ECOG score 0-2.
4. Meets the NCCN/CSCO guideline-defined criteria for relapsed/refractory disease and confirmed CD19-positive hematologic malignancy.
5. Liver, kidney, heart, and lung functions meet the following requirements:
* Creatinine ≤1.5×ULN;
* Left ventricular ejection fraction ≥45%;
* Oxygen saturation \>91%;
* Total bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN.
6. Absolute lymphocyte count ≥0.5×10⁹/L; platelet count ≥50×10⁹/L; CD3-positive T cells ≥150/uL.
7. Prophylactic anti-allergy medications (e.g., promethazine, diphenhydramine) should be administered 15-30 minutes before investigational drug infusion to prevent cryoprotectant (e.g., DMSO)-related infusion reactions.
8. Subjects must have a body temperature ≤38°C within 24 hours before investigational drug infusion (excluding tumor fever).
9. Within 5 days prior to investigational drug infusion, subjects must not receive therapeutic doses of corticosteroids (\>5mg/day prednisone or equivalent) or other immunosuppressive drugs.
10. Before investigational drug infusion, subjects must meet the required washout period per Appendix 3 (Drug/Treatment Discontinuation Schedule). (11) Capable of understanding the trial and having signed informed consent.
Exclusion Criteria:
1. Patients judged by investigators to require long-term use of immunosuppressants during screening.
2. Occurrence of cerebrovascular accident or seizure within 3 months prior to signing informed consent.
3. Presence of other active malignancies besides the studied disease, excluding carcinoma in situ.
4. Peripheral blood hepatitis B virus (HBV) DNA titer exceeding normal reference range.
5. Severe cardiac diseases including but not limited to: unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA class ≥III), severe arrhythmia.
6. Unstable systemic diseases judged by investigators including but not limited to severe hepatic, renal or metabolic diseases requiring medication.
7. Patients whose acute toxic effects from prior treatment have not yet resolved.
8. Active or uncontrolled infections requiring systemic treatment (excluding mild genitourinary and upper respiratory infections).
9. Female subjects of childbearing potential planning pregnancy within 2 years after investigational drug infusion; or male subjects whose partners plan pregnancy within 2 years after infusion.
10. Prohibited use of investigational drug when following complications exist: clinical evidence of active infection, fluid overload or congestive heart failure, drug-uncontrolled arrhythmia, hypotension requiring vasopressor support.Other situations deemed unsuitable for enrollment/investigational drug infusion by investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT07330895
Study Brief:
Protocol Section:
NCT07330895