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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT05523661
Eligibility Criteria:
Inclusion Criteria:
* (1)55 to 70 Years Old, Male and female;
* (2) Newly diagnosed Ph-positive ALL
* (3) ECOG score 0-1;
* (4) The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
* (5) Liver, kidney and cardiopulmonary functions meet the following requirements:
1. Creatinine is in the normal range;
2. Left ventricular ejection fraction \>50%;
3. Baseline oxygen saturation\>92%;
4. Total bilirubin ≤ 1.5×ULN;
5. ALT and AST ≤ 2.5×ULN;
* (6) Able to understand and sign the Informed Consent Document
Exclusion Criteria:
* (1) Disease relapse;
* (2) Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
* （3) ECOG \>=2 during CAR-T therapy
* (4) Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease; Heart disease including the following condition
1. Ultrasound shows left ventricular ejection fraction \<50%;
2. stable/unstable angina,myocardia infarction
3. Baseline oxygen saturation\>92%;
4. history of pacemaker inplantation
5. more than 2 leads ST segments decrease\>1mm,or more than 2 consecutive leads T wave inversion;
6. Long QT syndrom
7. A severe arrhythmia requiring medical treatments
8. bradycardia,HR\<50BPM I.QTc\>450ms
* (5)Uncontrolled infection during screening peroid; Hemodynamic instability associated with infection,a new infection or aggravation of the original infection;new lesions on imaging;fever of unkown cause
* (6) Patients with symptoms of central nervous system;greater than grade 2 requring treatment,paralysis,aphasia,acute cerebral infarction,severe traumatic brain injury,schizophrenia
* (7)Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
* (8) HIV infection
* (9)Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
* (10) Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
* (11) allergy to Dasatinib
* (12) history of autoimmune disaese
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT05523661
Study Brief:
Protocol Section:
NCT05523661