RecruitingPhase 1Phase 2NCT06064903

CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL

Phase I/II Study of Anti-CD7 Chimeric Antigen Receptor-Expressing T Cells in Pediatric Patients Affected by Relapsed/Refractory CD7+ T-cell Acute Lymphoblastic Leukemia/Lymphoma


Sponsor

Bambino Gesù Hospital and Research Institute

Enrollment

26 participants

Start Date

Apr 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The main purpose of this study is to evaluate the safety, to establish the recommended dose, and to evaluate the antitumor effect of CD7-CART01 in pediatric patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LL).


Eligibility

Min Age: 6 MonthsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a type of immune cell therapy called CAR-T cells for children with a rare and aggressive blood cancer called T-cell acute lymphoblastic leukemia or lymphoma (T-ALL/LL) that has come back or stopped responding to treatment. The CAR-T cells are engineered to target a protein called CD7 found on these cancer cells. **You may be eligible if...** - You are a child or young person with CD7-positive T-ALL or T-lymphoma - Your cancer has relapsed (come back) or is refractory (not responding) after at least one round of standard treatment - You have relapsed after a bone marrow transplant (at least 100 days post-transplant, no active graft-versus-host disease) - You may have cancer spread to the brain/spinal fluid or other sites outside the bone marrow **You may NOT be eligible if...** - Your cancer cells do not express the CD7 protein (less than 98%) - You are on immunosuppressants within 30 days - You have active graft-versus-host disease after transplant 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.

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Interventions

BIOLOGICALCD7-CART01

A single IV infusion of CD7-CART01 on Day 0


Locations(1)

Ospedale Pediatrico Bambino Gesù

Rome, Rome, Italy

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NCT06064903


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