Using CD5 CAR-T Cells to treat relapsed T-lymphoma

A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma

This study is testing a new type of CAR-T cell therapy to see if it can help people with relapsed T-lymphoma feel better and improve their health.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, CAR-T
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06633341 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of CD5 CAR-T cell therapy in patients with relapsed or refractory CD5-positive T-lymphoma. A total of 30 patients will receive this innovative treatment, which has shown promise in previous studies. The trial aims to gather more safety data and assess the therapeutic impact of this approach on the target population. Participants will be closely monitored for their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are individuals with relapsed or refractory CD5-positive T-lymphoma who have not responded to previous treatments.

Not a fit: Patients without CD5 expression or those with other types of lymphoma may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat T-lymphoma.

How similar studies have performed: Previous studies have indicated potential success with CAR-T cell therapies, making this approach promising yet still under evaluation.

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.

Where this trial is running

Hangzhou, Zhejiang

• The first affiliated hospital of medical college of zhejiang university — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: He Huang, MD — First Affiliated Hospital of Zhejiang University
• Study coordinator: He Huang, MD

Conditions T-lymphoblastic Lymphoma; CD5 CAR-T