Overview
A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-lymphoma
Description
In this study, 30 patients with relapsed refractory T-lymphoma were proposed to undergo CD5 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD5 CAR-T Cells therapy for relapsed refractory T-lymphoma; At the same time, on the basis of expanding the sample size, more safety data on CD5 CAR-T Cells treatment for relapsed refractory T-lymphoma were accumulated.
Eligibility
Inclusion Criteria:
- 1. According to the 2016 WHO classification of lymphocyte tumors, histologically confirmed CD5-positive T-cell non-Hodgkin lymphoma (T-NHL),
R/R T-NHL(meets one of the following conditions) :
- Subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments;
- Primary drug resistance;
- Relapse after autologous hematopoietic stem cell transplantation;
- 2.CD5 expression rate was >90%;
- 3. According to Lugano 2014, there should be at least one evaluable tumor lesion;
- 4. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);
- 5. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
- 6. Refers to the pulse oxygen saturation 92% or higher oxygen (state);
- 7. Estimated life expectancy of minimum of 12 weeks;
- 8. ECOG 0-2;
- 9. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
- 10. Those who voluntarily participated in this trial and provided informed consent;
Exclusion Criteria:
- 1. History of epilepsy or other central nervous system disorders;
- 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- 3. Active infection of hepatitis B virus, C virus or hepatitis E virus;
- 4. Active infected persons who are not cured;
- 5. Before using any gene therapy products;
- 6. Received anti-tumor therapy before infusion, should meet the following any one
should be ruled out:
- treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone < 10 mg/d or an equivalent dose of the drug);
- received within 72 hours of small molecule targeted therapy;
- 2 weeks received systemic chemotherapy except (pretreatment);
- four weeks received radiotherapy;
- 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation
signal;
- 8. Any unsuitable to participate in this trial judged by the investigator;
- 9. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.