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:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT04303520
Eligibility Criteria:
Inclusion Criteria:
1. 13 Years to 70 Years, Male and female;
2. Expected survival \> 12 weeks;
3. Clinical performance status of ECOG score 0-2;
4. Histologically confirmed as CD19-positive lymphoma and who meet one of the following conditions:
* Patients received at least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
* Disease recurrence after stem cell transplantation.
5. Accessible to intravenous injection, and no white blood cell collection contraindications
6. Patients who meet the following conditions:
* Creatinine \< 2.5 mmol/l;
* Cardiac ejection fraction\>50%, no pericardial effusion and no pleural effusion (ECHO examination);
* Baseline oxygen saturation\>92%;
* Total bilirubin≤1.5xULN;
* ALT/AST≤2.5x normal.
7. Able to understand and sign the Informed Consent Document.
Exclusion Criteria:
1. Accompanied by other malignant tumor
2. Active hepatitis B, hepatitis C, syphilis, HIV infection
3. Suffering severe cardiovascular or respiratory disease
4. Any other diseases could affect the outcome of this trial
5. Any affairs could affect the safety of the subjects or outcome of this trial
6. Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment
7. Occurrence of infection uncontrolled or requiring systemic treatment 14 days prior to assignment
8. Patients who are accounted by researchers to be not appropriate for this test
9. Received CAR-T treatment or other gene therapies before assignment
10. Patients with symptoms of central nervous system
11. Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
70 Years
Study:
NCT04303520
Study Brief:
Protocol Section:
NCT04303520