NCT06633341 Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma
| NCT ID | NCT06633341 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Zhejiang University |
| Condition | T-lymphoblastic Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-10-20 |
| Primary Completion | 2027-10-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-10-20 with a primary completion date of 2027-10-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
He Huang, MD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT06633341 clinical trial?
This trial is open to participants of all sexes, studying T-lymphoblastic Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06633341 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06633341 currently recruiting?
Yes, NCT06633341 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT06633341 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06633341 clinical trial?
NCT06633341 is sponsored by Zhejiang University. The principal investigator is He Huang, MD at First Affiliated Hospital of Zhejiang University. The trial plans to enroll 30 participants.