RecruitingPhase 1NCT05098613

Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients

Phase 1 Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Adolescent and Adult Patients With Relapsed and/or Refractory B-Non-Hodgkin's Lymphoma (B-NHL)


Sponsor

University of Colorado, Denver

Enrollment

68 participants

Start Date

Dec 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed/refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called CD19x22 CAR T cells — immune cells re-engineered to attack two targets on cancer cells at once — for people with B-cell blood cancers that have come back or stopped responding to prior treatments. **You may be eligible if...** - You are 16 years or older (first three participants must be 18+) - You have aggressive B-cell lymphoma (such as Diffuse Large B-Cell Lymphoma) that has relapsed or is treatment-resistant, OR B-cell cancer that has spread to the brain or spinal cord - You have received prior standard treatments that have not worked **You may NOT be eligible if...** - You have signs of active, uncontrolled disease in the central nervous system (for non-CNS group) - You have serious heart, lung, or kidney problems that could prevent safe treatment - You are pregnant or breastfeeding - Your blood counts are too low to safely undergo the therapy 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

DRUGCD19x22 CAR T Cells

Autologous peripheral blood mononuclear cells transduced with CD19x22 CAR T lentiviral vector.


Locations(1)

University of Colorado Hospital

Aurora, Colorado, United States

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NCT05098613


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