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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT04037566
Eligibility Criteria:
Inclusion Criteria:
* Subject must meet all the following criteria to be selected:
1. Willing to provide consent/assent for participation in the study by patient or his/her legal guardian;
2. Male or Female subjects age ≥18 and ≤55 years;
3. Evidence of relapsed/refractory CD19+ B cell hematological malignancies. The most common relapsed/refractory B cell hematological malignancies include: (1) B cell acute lymphoblastic leukemia (B-ALL); (2) B cell lymphomas, including indolent B cell lymphoma (CLL, FL, MZL, LPL, HCL) and aggressive B cell lymphoma (DLBCL, BL, MCL)；
4. Subjects (20 subjects of B cell acute lymphoblastic leukemia and 20 subjects of B cell lymphoma) with the following conditions:
1. Failure to achieve complete remission (CR) after at least two lines of standard chemotherapy while not suitable for HSCT (auto/allo-HSCT)；
2. Relapse after CR, but not eligible for HSCT (auto/allo-HSCT);
3. Failure to achieve remission or relapse after HSCT;
5. Leukemia patient confirmed by bone marrow aspiration that has not been alleviated; lymphoma patient with measurable or assessable lesions;
6. Adequate organ function:
1. Liver: ALT/AST ≥ 3 × ULN, total bilirubin ≤34.2 mol/L;
2. Kidney: Creatinine\<220 µmol/L, creatinine clearance rate (CCR) ≥ 60 mL/min;
3. Lung: arterial oxygen saturation ≥95%;
4. Heart: Left ventricular ejection fraction (LVEF) ≥40%;
5. Absolute lymphocyte count (ALC) ≥ 100/μL, absolute neutrophil count (ANC) ≥ 1,000/μL, platelets (PLT) ≥ 75,000/μL;
7. No prior anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy (immunosuppression) within 4 weeks prior to enrollment, and toxic reactions of all prior treatments recovered to grade ≤1 at the time of enrollment (except for low toxicity such as alopecia);
8. Presence of smooth peripheral superficial venous blood flow to fulfill intravenous infusion;
9. Karnofsky performance score ≥60; ECOG ≤2; estimated survival ≥3 months.
Exclusion Criteria:
* Subjects meeting one or more of the following criteria will be excluded:
1. Female patient who is pregnant or breastfeeding ;
2. Male or Female patient within Pregnancy Program in 1 year;
3. Unwilling or unable to guarantee effective contraceptive measures (condoms or contraceptives) within 1 year after enrollment;
4. Presence of uncontrolled infectious disease within 4 weeks prior to enrollment:
5. Active hepatitis B or hepatitis C infection;
6. HIV infection;
7. Active TB;
8. Presence of active malignancy other than disease under study, confirmed by pathology;
9. Severe autoimmune diseases or immunodeficiency;
10. Suffering from allergies;
11. Joining another clinical trial within 6 weeks prior to enrollment;
12. Using systemic corticosteroid within 4 weeks prior to enrollment (except for those who use inhaled steroids);
13. Psychiatric disorders;
14. History of epilepsy and seizures or other CNS pathology;
15. Addiction to or abuse of drugs;
16. Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04037566
Study Brief:
Protocol Section:
NCT04037566