Last updated: November 11, 2022
Sponsor: Shenzhen University General Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Lymphoma
Leukemia
Treatment
N/AClinical Study ID
NCT05620680
HEM-ONCO-017
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;
- The subject voluntarily participates in the research and signs the "Informed Consent"by himself or his legal guardian;
- According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)/acute lymphoblastic leukemia (2020. V1) practice guidelines, diagnosed withT-cell lymphoma;
- Meet the diagnostic criteria for relapsed/refractory T-cell lymphoma, including any ofthe following:
- Failure to obtain CR at the end of induction therapy; 2) Patients who have obtained CRhave blasts in peripheral blood or bone marrow (proportion >5%), or extramedullarydiseases; 5. Have not received antibody therapy within 2 weeks before cell therapy; 6. ECOGscore of 0-2; 7. The subject has no contraindications to peripheral apheresis; 8. Expectedsurvival time of more than 3 months.
Exclusion
Exclusion Criteria:
- Those who have a history of allergy to any of the ingredients in cell products;
- Laboratory tests for the following: including but not limited to, total serumbilirubin≧ 1.5mg/dl; Serum ALT or AST greater than 2.5 times the upper limit ofnormal; Blood creatinine≧ 2.0mg/dl; Platelet count≦ 10×109/L;
- Patients with cardiac insufficiency who belong to class III or IV according to the NewYork Cardiology Association (NYHA) cardiac function grading standards; orechocardiography with left ventricular ejection fraction (LVEF) < 50%;
- Abnormal lung function, blood oxygen saturation under indoor air < 92%;
- Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or otherserious clinical heart disease within 12 months before enrollment;
- Grade 3 hypertension with poor control of blood pressure with medication;
- Patients with other advanced tumors (those who are assessed as stable after treatmentof other tumors can be enrolled);
- Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemiaor cerebral hemorrhage disease;
- Known central nervous system leukemia (CNS2 or CNS3), resistance to intrathecalchemotherapy injections and/or ongoing head and/or spinal radiation therapy; PreviousCNS history but has been effectively controlled to allow enrollment;
- Patients with autoimmune diseases, immunodeficiency or other patients requiringimmunosuppressant therapy;
- presence of uncontrolled, active infection;
- Have previously used any CAR-T cell product or other genetically modified T celltherapy;
- Live vaccination within 4 weeks prior to enrollment;
- HIV, HBV, HCV and TPPA/RPR infections, and HBV carriers;
- Subject has a history of alcoholism, drug addiction or mental illness;
- The subject has participated in any other clinical research within 3 months beforejoining this clinical study;
- Female subjects have any of the following conditions: a) are pregnant/lactating; or b)have plans to become pregnant during the trial; or c) are of childbearing potentialand unable to use effective contraception;
- There are other circumstances in which the investigator believes that the subject isnot suitable for this study.
Study Design
Total Participants: 20
Study Start date:
October 01, 2022
Estimated Completion Date:
October 31, 2028
Study Description
Connect with a study center
Li Yu
Shenzhen, Guangdong 518000
ChinaActive - Recruiting
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