Production and expansion of CAR-NK cells from patients and healthy donors
Production and Expansion of Chimeric Antigen Receptor (CAR)-Natural Killer (NK) Cells From Patients Affected by Lympho or Myeloproliferative Disorders and From Healthy Donors
This study is testing how to grow special immune cells from the blood of patients with blood disorders and healthy donors to see if they can be used to fight cancer more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Milano) |
| Trial ID | NCT06727383 on ClinicalTrials.gov |
What this trial studies
This study focuses on the manufacturing and expansion of CAR-NK cells from peripheral blood mononucleated cells and CD34+ cells of individuals with myelo or lymphoproliferative disorders, as well as healthy donors. The process involves collecting blood samples, selecting specific cell types, and expanding NK cells using various supportive supplements. The primary goal is to evaluate the cytotoxic activity of these engineered cells in preclinical models, which could lead to advancements in immunotherapy for hematological diseases.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with myelo or lymphoproliferative diseases.
Not a fit: Patients with psychiatric disorders or active viral and bacterial infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of immunotherapy for patients with certain blood disorders.
How similar studies have performed: Other studies have shown promising results with similar CAR-NK cell approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects over the age of 18 capable of understanding and willing * Subjects affected by myelo/lymphoproliferative diseases Exclusion Criteria: * Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study. * Patients affected by lympho or myeloproliferative disorders and Healthy Donors with known acute and chronic viral and bacterial infections :HIV, HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), syphilis
Where this trial is running
Milano
- Istituto Europeo di Oncologia — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Enrico Derenzini, MD — Istituto Europeo di Oncologia
- Study coordinator: Enrico Derenzini
- Email: enrico.derenzini@ieo.it
- Phone: +390257489538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.