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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT04008394
Eligibility Criteria:
Inclusion Criteria:
1. Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
2. Male or female patients aged 18 to 70 years (including 18 and 70 years old).
3. Pathological and histological examination confirmed CD30+ lymphocyte malignancies, and patients currently have no effective treatment options, such as chemotherapy or recurrence after hematopoietic stem cell transplantation; or patients voluntarily choose Anti-CD30 CAR-T as rescue treatment.
4. CD30+ lymphocyte malignancies:
1. Adult T-cell leukemia/lymphoma
2. Anaplastic large cell lymphoma (ALCL);
3. Angioimmunoblastic T-cell Lymphoma (AITL);
4. NK/T-cell lymphoma;
5. Peripheral T-cell lymphoma (PTCL);
6. Hodgkin lymphoma;
5. Subjects:
1. There are still residual lesions after major treatment, and they are not suitable for HSCT (auto/allo-HSCT);
2. Recurrence occurs after CR1, and HSCT (auto/allo-HSCT) is not selected or suitable because of self-willingness;
3. After hematopoietic stem cell transplantation or cellular immunotherapy, the patient suffered relapse or did not remission.
6. Having a measurable or evaluable lesion.
7. Patient's main organs function well：
1. Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and
2. total bilirubin≤34.2μmol/L
3. Renal function: Creatinine \< 220μmol/L.
4. Pulmonary function: Indoor oxygen saturation≥95%.
5. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%.
8. The patients did not receive any anticancer treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before admission, and the toxicity related to previous treatments had returned to \< 1 level at admission (except for low toxicity such as alopecia).
9. The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.
10. Patient ECOG score≤2, Estimated survival time≥3 months.
Exclusion Criteria:
1. Women who are pregnant (urine/blood pregnancy test positive) or lactating.
2. Male or female with a conception plan in the past 1 years.
3. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
4. Uncontrolled infectious disease within 4 weeks prior to enrollment.
5. Active hepatitis B/C virus.
6. HIV infected patients.
7. Suffering from a serious autoimmune disease or immunodeficiency disease.
8. The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
9. The patient participated in other clinical trials within 6 weeks prior to enrollment.
10. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
11. Have a history of epilepsy or other central nervous system diseases.
12. Having drug abuse/addiction.
13. According to the researcher's judgment, the patient has other unsuitable grouping conditions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04008394
Study Brief:
Protocol Section:
NCT04008394