A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-lymphoma

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.

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) :

1. Subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments;

2. Primary drug resistance;

3. 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:

  1. 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);
  2. received within 72 hours of small molecule targeted therapy;
  3. 2 weeks received systemic chemotherapy except (pretreatment);
  4. 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.