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Trial Title:
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma
NCT ID:
NCT06633341
Condition:
T-lymphoblastic Lymphoma
Conditions: Official terms:
Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Conditions: Keywords:
CD5 CAR-T
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CD5 CAR T-cells
Description:
Each subject receive CD5+ T-lymphoma Targeted CAR T-cells by intravenous infusion
Arm group label:
Administration of CD5+ T-lymphoma Targeted CAR T-cells
Other name:
CD5+ T-lymphoma Targeted CAR T-cells injection
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The first affiliated hospital of medical college of zhejiang university
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
He Huang, PhD
Phone:
057187233772
Email:
hehuangyu@126.com
Contact backup:
Last name:
Yongxian Hu, PhD
Phone:
057187233772
Email:
huyongxian2000@aliyun.com
Start date:
October 20, 2024
Completion date:
October 20, 2027
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Shanghai YaKe Biotechnology Ltd.
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06633341
