RecruitingPhase 1NCT06080191

Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL

Phase I Clinical Trial on the Use of Fresh, Allogeneic, Second-generation CD19-CAR T Cells for Treatment of Children With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia


Sponsor

Bambino Gesù Hospital and Research Institute

Enrollment

24 participants

Start Date

Apr 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I, open label study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of allogeneic, CD19-directed Chimeric Antigen Receptor T (alloCAR-T) cells in pediatric and young adults patients with relapsed/refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL).


Eligibility

Min Age: 1 YearMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is testing allogeneic (donor-derived) second-generation CD19-CAR T cells — genetically engineered immune cells designed to seek out and destroy cancer cells carrying the CD19 protein — in children with B-cell acute lymphoblastic leukemia (B-ALL) that has come back or has not responded to treatment. **You may be eligible if...** - You are a child with B-ALL that has relapsed after a stem cell transplant from a donor, OR your cancer has relapsed/not responded after standard treatment and at least 2 rescue therapies including a CD19/CD22-targeted antibody treatment - Your cancer cells have CD19 expression (at least 50 CD19+ cells per microliter or detectable minimal residual disease) - A fully matched related donor is available **You may NOT be eligible if...** - Your cancer does not express CD19 - You have not yet tried the required prior treatments - A fully matched related donor is not available 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

DRUGCD19-CAR_Lenti_ALLO

Biological/Vaccine: CD19-CAR\_Lenti\_ALLO A single infusion of CD19-CAR\_Lenti\_ALLO on Day 0


Locations(1)

Ospedale Pediatrico Bambino Gesù

Rome, Italy, Italy

View Full Details on ClinicalTrials.gov

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

Visit

NCT06080191


Related Trials