RecruitingPhase 1NCT06709469

Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults

A Phase I Clinical Trial of CART Cell Therapy for Refractory/ Relapsed Acute Lymphoblastic Leukemia With Unmet Needs in Children, Adolescents and Young Adults: Feasibility and Safety Study (REALL_CART).


Sponsor

Instituto de Investigación Hospital Universitario La Paz

Enrollment

10 participants

Start Date

Jul 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test the feasibility and safety of an academic production of two different anti-CD19 chimeric antigen receptor T cells (CART) products according to the different biomarkers of the disease in children and young adults with relapsed/refractory CD19+ B cell acute lymphoblastic leukemia (r/r B-ALL) or relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). The main questions it aims to answer are: 1. The safety and feasibility of autologous CART-19/22 in children, adolescents and young adults with a CD19+/- CD22+ relapse/ refractory disease for a r/r B-ALL. 2. The safety and feasibility of allogeneic CART-NKG2D (chimeric-antigen receptor Natural-killer group 2, member D) in children, adolescents and young adults with r/r T-ALL.


Eligibility

Max Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing a new type of cell therapy called CAR-T cells in children, teenagers, and young adults with acute lymphoblastic leukemia (ALL) that has come back or stopped responding to standard chemotherapy. **You may be eligible if...** - You have B-cell or T-cell ALL that has relapsed (come back) or is refractory (not responding) to standard chemotherapy - No other standard curative treatment is available - You would be eligible for a stem cell transplant if the CAR-T treatment achieves remission - Your performance score indicates you are well enough to participate - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - Your leukemia has not been refractory or relapsed - You are not eligible for a stem cell transplant - You have conditions that would make CAR-T cell therapy unsafe - For the T-cell leukemia arm: there is no suitable matching donor 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.

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Interventions

BIOLOGICALAutologous CD19/CD22 CAR T cells

A total of two doses of autologous CD19/CD22 CAR T cells (first dose of up to 0.75x106/kg fresh cells), and a second infusion of unfrozen cells (same dose) if there has been no ≥ grade 1 cytokine-release syndrome (CRS) in the next 72 h; intravenously.

BIOLOGICALAllogeneic CART-NKG2D cells

A total of up to 3x106/kg allogeneic CART-NKG2D cells divided in three doses of up to 1x106/kg will be infused; intravenously. First infusion of fresh cells, and the 2nd and 3rd infusion of unfrozen cells (same dose) if there has been no ≥ grade 1 CRS (every 48 hours).


Locations(1)

Hospital Universitario La Paz

Madrid, Madrid, Spain

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NCT06709469


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