T-Acute Lymphoblastic Leukemia
Conditions
Keywords
CD5 CAR-T
Brief summary
A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL
Detailed 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.
Interventions
BIOLOGICALCD5 CAR T-cells
Each subject receive CD5+ T-ALL Targeted CAR T-cells by intravenous infusion
Sponsors
Yake Biotechnology Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactHe Huang, MD
Backup ContactYongxian Hu, MD
Outcome results
None listed