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

In this study, 30 patients with relapsed refractory T-ALL 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-ALL; 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-ALL were accumulated.

Inclusion Criteria:

• 1. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;

• 2. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:

  1. No CR after standard chemotherapy;
  2. The first induction reaches CR, but CR ≤ 12 months;
  3. Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;

  c.Multiple recurrences.

• 3. CD5 expression rate was >90%;

• 4. Number of blasts in the bone marrow (protolychic + larvae) >5% (morphology) and/or >1% (flow cytometry);

• 5. 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);

• 6. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;

• 7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);

• 8.Estimated life expectancy of minimum of 12 weeks;

• 9.ECOG 0-2;

• 10.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;

• 11. Those who voluntarily participated in this trial and provided informed consent;

Exclusion Criteria:

• 1.Patients with the history of epilepsy or other CNS disease;

• 2. Patients with prolonged QT interval time or severe heart disease;

• 3. Active infection of hepatitis B virus, C virus or hepatitis E virus;

• 4. Active infection with no cure;

• 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.