T-lymphoblastic Lymphoma
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-lymphoma
Detailed description
In this study, 30 patients with relapsed refractory T-lymphoma 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-lymphoma; 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-lymphoma were accumulated.
Interventions
BIOLOGICALCD5 CAR T-cells
Each subject receive CD5+ T-lymphoma 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 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.
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