CELL INTELLIGENCE · 肿瘤细胞治疗研究

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.

主要终点：Dose-limiting toxicity (DLT) · Adverse events assessed according to NCI-CTCAE v5.0 criteria · Up to 28 days after Treatment；Incidence of treatment-emergent adverse events (TEAEs) · Incidence of treatment-emergent adverse events \[Safety and Tolerability\] · Up to 2 years after Treatment
次要终点：Overall response rate ,ORR；Duration of remission ,DOR；Progression Free Survival, PFS；Overall survival, OS

• Administration of CD5+ T-lymphoma Targeted CAR T-cells · EXPERIMENTAL · Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

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