Overview
A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL
Description
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.
Eligibility
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:
- No CR after standard chemotherapy;
- The first induction reaches CR, but CR ≤ 12 months;
- 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:
- 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.
