Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

Recruitment & 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;
1. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:
2. No CR after standard chemotherapy;
3. The first induction reaches CR, but CR ≤ 12 months;
4. Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;
c.Multiple recurrences.
1. CD5 expression rate was >90%;
1. Number of blasts in the bone marrow (protolychic + larvae) >5% (morphology) and/or >1% (flow cytometry);
1. 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);
1. 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;
1. Those who voluntarily participated in this trial and provided informed consent;

Exclusion Criteria

1.Patients with the history of epilepsy or other CNS disease;
1. Patients with prolonged QT interval time or severe heart disease;
1. Active infection of hepatitis B virus, C virus or hepatitis E virus;
1. Active infection with no cure;
1. Before using any gene therapy products;
1. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:
2. 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);
3. received within 72 hours of small molecule targeted therapy;
4. 2 weeks received systemic chemotherapy except (pretreatment);
5. four weeks received radiotherapy;
1. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
1. Any unsuitable to participate in this trial judged by the investigator;
1. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

Study & Design

Arm && Interventions

Group	Intervention	Description
Administration of CD5+ T-ALL Targeted CAR T-cells	CD5 CAR T-cells	Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	Up to 28 days after Treatment	Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)	Up to 2 years after Treatment	Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Secondary Outcome Measures

Name	Time	Method
Overall response rate ,ORR	Up to 12 weeks after CAR-T infusion	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Duration of remission ,DOR	Up to 1 years after CAR-T infusion	The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Progression Free Survival, PFS	Up to 2 years after Treatment	The time from randomization or start of study treatment until objective tumor progression or death
Overall survival, OS	Up to 1 years after CAR-T infusion	The time from CAR-T infusion to death due to any cause

Recruitment & Eligibility