RecruitingPhase 1NCT06559189

CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL

Phase I Dose Escalation and Preliminary Efficacy Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Pediatric Patients With Relapsed and/or Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)


Sponsor

University of Colorado, Denver

Enrollment

53 participants

Start Date

Sep 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.


Eligibility

Min Age: 3 MonthsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR T-cell therapy — where a patient's own immune cells are engineered to attack cancer — that targets two proteins on cancer cells (CD19 and CD22) at the same time. It is designed for children and young adults with B-cell acute lymphoblastic leukemia (B-ALL) that has relapsed or stopped responding to standard treatments. **You may be eligible if...** - You are aged 3 months to 30 years with B-cell ALL that has relapsed or is treatment-resistant - Your leukemia has relapsed at least twice, relapsed after a bone marrow transplant, relapsed or failed after CAR T-cell therapy, or your doctors have determined standard therapy is not working - Your cancer still expresses CD19 and/or CD22 markers - You have adequate functional status (Lansky or Karnofsky ≥ 50%) **You may NOT be eligible if...** - You have active, uncontrolled central nervous system leukemia - You have received a prior CAR T infusion within the last 90 days - You have severe organ dysfunction - 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.

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Interventions

BIOLOGICALCD19x22 CAR T

The investigational product is an autologous, genetically modified CD19xCD22 CAR T cell product produced by the Gates Biomanufacturing Facility.


Locations(1)

Children's Hospital Colorado

Aurora, Colorado, United States

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NCT06559189


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