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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT06027957
Eligibility Criteria:
Inclusion criteria:
* B-cell acute lymphoblastic leukemia: refractory to two cycles of chemotherapy, relapsed after chemotherapy, or hematopoietic stem cell transplantation.
* B-cell non-Hodgkin lymphoma: refractory to two lines of chemotherapy, relapsed after chemotherapy, or hematopoietic stem cell transplantation.
* Age: From 1 to 60 years old (both males and females)
* Adequate organ functions:
* Serum creatinine ≤ 1.5 x ULN or eGFR ≥ 60 mL/min/1.73 m2
* ALT and AST ≤ 5 x ULN; Bilirubin ≤ 2.0 mg/dl
* No chronic lung diseases, such as obstructive pulmonary disease or bronchial asthma, required continuous medications without respiratory failure (SpO2 oxygen saturation \> 92% at room temperature).
* No arrhythmia, no intracardiac thrombus or vascular wall, no heart failure, LVEF ≥ 45%
* Blood test:
* Absolute neutrophil count (ANC) ≥ 1,000/mm3 (1 G/l) without filgrastim
* Absolute lymphocyte count ≥ 100/mm3 (0.1 G/l)
* Absolute platelet count ≥ 75,000/mm3 (75 G/l)
* Hemoglobin ≥ 8.0 g/dl
* Positive for CD19 measured by immunohistochemistry or flow cytometry.
* Agree to participate in the study
* Agree to use safe methods of contraception for female patients.
Exclusion criteria:
* Involved central nervous system invasion at the time of screening.
* Medical history of veno-occlusive disease (VOD).
* Required acute treatment due to tumors such as intestinal obstructions, vascular compression, or respiratory failure.
* Having active hemolytic anemia.
* Diagnosed with primary immunodeficiency.
* Medical history of autoimmune neurological diseases or neuromyelitis.
* Receiving immunosuppressive medication, except for ≤ 30 mg prednisolone or equivalent at the time of CAR-T-cell transfusion.
* Having acute, progressive, or chronic graft-versus-host disease (GvHD).
* Having active infectious diseases determined by clinical, imaging, or other laboratory tests (blood culture, PCR, etc.)
* Patients who are critically ill or at risk of premature death characterized by:
* Acute liver failure requiring dialysis
* Heart failure requiring vasopressors
* Systemic infection unresponsive to antibiotics
* ECOG performance status ≥ 3 points at the time of screening
* Having other severe concomitant diseases (e.g., uncontrolled arterial hypertension, heart failure NYHA III-IV).
* Unstable angina within 3 months prior to screening.
* Any previous or concurrent malignancy was not B-cell lymphoma or B-ALL.
* Medical history of clinically relevant central nervous system disease, such as epilepsy, convulsions, paralysis, aphasia, uncontrolled cerebrovascular disease, traumatic brain injury, and Parkinson's disease.
* Intolerance to excipients from cellular products.
* Pregnant women or those who expect to be pregnant or reastfeeding.
* Other diseases or other conditions and circumstances that, according to the investigator's assessment, make it difficult to ensure compliance with study treatment.
* Participation in another clinical trial at the time of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
60 Years
Study:
NCT06027957
Study Brief:
Protocol Section:
NCT06027957