Clinical Trials in China / NCT06633341
Recruiting
Early Phase 1
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma
NCT06633341 · tracked via the Priya Life Science China tracker
Condition(s) studied
T-lymphoblastic Lymphoma
Investigational drug(s) / intervention(s)
CD5 CAR T-cells
CD5 CAR T-cells: Each subject receive CD5+ T-lymphoma Targeted CAR T-cells by intravenous infusion
Study summary
A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-lymphoma
Eligibility
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.
Primary outcome measure(s)
- 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 \[Safety and Tolerability\]
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The first affiliated hospital of medical college of zhejiang university | Hangzhou | Zhejiang | Recruiting |
More Zhejiang University trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06633341 on ClinicalTrials.gov ↗ ← All trials in China