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 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT06231368
Eligibility Criteria:
Inclusion Criteria:
* Subject and/or subject's legal personal representative fully understand and voluntarily sign informed consent forms
* Male or female age ≥ 12 years
* Subjects with autoimmune hemolytic anemia or Evans syndrome after Failure ≥3 lines of therapy. The Failure of ≥3 lines of therapy meets all the following conditions: Hemoglobin less than 10g/dl and symptoms of anemia; Failure of first-line corticosteroid therapy; Failure of second-line rituximab therapy; Failure of any one or more of the third-line treatments (splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, fludarabine, bortezomib, etc.)
* Female subjects of childbearing potential must have a negative Serum HCG test within 7 days before enrollment. Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the 1-year follow-up after cell infusion
* Laboratory tests of adequate organ function: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; and have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and the blood oxygen saturation in a non-oxygenated state is \>93%
* ECOG performance status ≤2
* Subject with a life expectancy of more than 3 months
Exclusion Criteria:
* History of other lymphoproliferative neoplasms
* Secondary AIHA caused by drugs or infection
* Platelets in subjects with Evans syndrome\<30×10\^9/L
* Pregnant or breast-feeding subjects
* Treatment with any of the following within the noted period prior to study entry: a.anti-CD20 monoclonal antibodies \<12 weeks, b.sutimlimab or other marketed biologics \<5 half-lives; c.plasma exchange \<4 weeks; d.post-splenectomy \<12 weeks
* Previously received organ or stem cell transplantation
* History of new thrombosis or organ infarction in the past 6 months
* Diagnosis of the active stage of the connective tissue disease
* Had other inherited or acquired hemolytic diseases
* Have active infections, such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection and active tuberculosis, etc.
* Positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is above the lower limit of the measurable capacity; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis test
* Received major surgery within 4 weeks before screening that was assessed by the researcher as unsuitable for enrollment
* Have malignant tumors within 5 years before enrollment, except tumors with negligible risk of metastasis or death and curable tumors, such as adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma, etc.
* Have any of the following cardiovascular diseases: a.Left ventricular ejection fraction (LVEF) ≤45%, b. presence of active heart disease or congestive heart failure (New York Heart Association \[NYHA\] Class III or IV)), c.severe arrhythmias requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia), d.QTcB interval ≥450ms for men and ≥470ms for women, e.have myocardial infarction, bypass surgery, or stent placement within the 6 months before the study, f.other heart diseases judged by the researcher to be unsuitable for enrollment
* Have a history of live attenuated vaccines within 6 weeks before enrollment
* Participate in other interventional clinical studies during CNCT19 CAR T-Cell therapy, and the drug has a half-life of \<5. Subjects treated with active investigational drugs or intend to participate in another clinical trial or receive treatment other than that specified in the protocol throughout the study period
* Have a history of epilepsy or other active central nervous system diseases
* Have an allergy to the ingredients of the medicine used in this study
* Previously received CAR-T cell therapy
* Patients considered to be ineligible for the study by the investigator for reasons other than the above
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT06231368
Study Brief:
Protocol Section:
NCT06231368