RecruitingPhase 2NCT05281809

Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia

A Feasibility Study Following a Phase 2a Design to Demonstrate Successful Local Manufacture of Chimeric Antigen Receptor (CAR) T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia


Sponsor

John Lister

Enrollment

30 participants

Start Date

Apr 19, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This trial aims to demonstrate the feasibility of this approach to reliably generate product and to safely administer the product to patients who have B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study offers locally made CAR T-cell therapy — a cutting-edge treatment that re-engineers your own immune cells to attack cancer — for adults with B-cell lymphoma or B-cell acute lymphoblastic leukemia (B-ALL) who have already tried multiple other treatments. The cells are manufactured on-site rather than through commercial manufacturers. **You may be eligible if...** - You are 18–79 years old with B-cell lymphoma or B-ALL that has not responded to at least 2 prior treatments (1 prior treatment for B-ALL) - Your cancer expresses the CD19 protein on its surface - You are not eligible for (or cannot access) commercially available CAR T-cell therapy - Your heart and lung function are adequate, and your performance score is reasonably good **You may NOT be eligible if...** - You have active HIV, hepatitis B, or hepatitis C infection - You have active brain or spinal cord involvement by your cancer (unless previously treated and stable) - You have had a recent heart attack or serious active infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGChimeric Antigen Receptor (CAR) T-Cell Product (Autologous)

This protocol describes the use of an automated cell processor and culture system, the CliniMACS Prodigy device sold by Miltenyi Biotec, for the local manufacture of CAR T-cells targeting the CD19 antigen. The manufacturing process will use a lentiviral vector (CAR19) provided by Lentigen, a wholly owned subsidiary of Miltenyi Biotec, to transfect T-cells collected from eligible patients. Live cells will be harvested by the device after culture and infused intravenously to the patient from whom the cells were originally obtained.


Locations(1)

AHN Cancer Institute - West Penn Hospital

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05281809


Related Trials