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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT06596057
Eligibility Criteria:
Inclusion criteria 1) CD19-positive recurrent, refractory, drug-resistant B-cell lymphoma and acute B-lymphoblastic leukemia. 2) Recurrent MRD-positive refractory acute B lymphoblastic leukemia, extramedullary leukemia lesions. 3) Age over 15 and under 80. 4) KPS≥50 or ECOG score ≤2 and expected survival greater than 3 months. 5) At least 2 weeks prior to apheresis or at least 5 drug half-lives (whichever is shorter) without systemic therapy (except systemic immune checkpoint suppression or activation therapy). 6) The absolute number of neutrophils is greater than 1.5x109 /L. 7) The absolute number of platelets is greater than 50x109 /L. 8) The absolute number of lymphocytes is greater than or equal to 0.15x109 /L. 9) ALT/AST is less than 3 times the normal value. 10) Total bilirubin less than 1.5mg/dl. 11) Creatinine less than 2.5mg/dl, or creatinine clearance ≥60 mL/min/1.73 m2. 12) The ejection fraction of the heart was greater than or equal to 45%, no pericardial effusion was found without echocardiography (ECHO), and electrocardiogram (ECG) was normal. 14) Blood oxygen saturation is greater than or equal to 92% under normal conditions. 15) No central nervous system metastasis was found in patients with central nervous system leukemia and lymphoma (symptoms, signs, imaging, cerebrospinal fluid). 16) Women of childbearing age who had a negative urine pregnancy test before dosing began and agreed to take effective contraception during the trial until the last follow-up visit. 17) Volunteer to participate in this experiment and sign the informed consent.
Exclusion criteria
1. Patients with expected survival of less than 3 months.
2. Clinical findings (symptoms, signs, imaging, cerebrospinal fluid) of central nervous system leukemia.
3. Patients with hyperleukocytoemia (white blood cell count ≥50 x109 /L) or patients whose disease is progressing rapidly at the time of enrollment, as determined by the investigator, to be unable to ensure the completion of a full treatment cycle.
4. Patients with skin cancer other than melanoma or other primary tumors (such as cervical cancer, bladder cancer, breast cancer) (unless cured for more than 3 years).
5. Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.
6. Patients who test positive for HIV, HBV, HCV.
7. Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases.
8. Myocardial infection, cardiac angiography or stenting, active angina pectoris or other obvious clinical symptoms, or cardiac asthma or cardiovascular lymphocyte infiltration in the 12 months prior to enrollment.
9. Those who are receiving anticoagulation therapy or have severe coagulation dysfunction.
10. According to the investigator's judgment, the drug treatment the patient is receiving will affect the safety and efficacy study of this project.
11. Patients with allergy or history of allergy to the biologics used in this project.
12. Pregnant or lactating women.
13. Systematic use of systemic or systemic steroid drugs within 2 weeks prior to treatment (except those who have recently or currently used inhaled steroids).
14. The efficiency of T cell transduction by replication-deficient lentivirus is less than 30%, or the ability to expand in response to CD3 / CD28 costimulatory signals is insufficient (\<5 times).
15. Those who have other uncontrolled diseases that the researchers consider unsuitable for enrollment.
16. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.
17. Patients who are also participating in other clinical studies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
80 Years
Study:
NCT06596057
Study Brief:
Protocol Section:
NCT06596057