RecruitingNot ApplicableNCT06355739

CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+

Phase II Clinical Study on the Safety and Efficacy of Autotransfusion Agents Targeting CD19 Chimeric Antigen Receptor T Lymphocytes (BIC-19GG, BIC-2019,BIC-2219)in the Treatment of CD19-positive Children With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma


Sponsor

Zhu Xiaofan

Enrollment

60 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children


Eligibility

Min Age: 3 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR T-cell therapy — a cutting-edge treatment that re-engineers the patient's own immune cells to attack cancer — for children with relapsed or treatment-resistant B-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma that expresses the CD19 protein. **You may be eligible if...** - You are between 3 and 18 years old with a diagnosed relapsed or treatment-resistant B-cell leukemia or lymphoma - Your cancer has returned after chemotherapy, or did not go into remission after at least 2 rounds of standard treatment - Your cancer cells test positive for CD19 (and/or CD20 or CD22) - Your Lansky score (a measure of physical activity in children) is 60 or above - Your heart, liver, and kidney function meet the required levels - Your expected survival is more than 3 months from the time of consent **You may NOT be eligible if...** - Your cancer cells do not express CD19, CD20, or CD22 - Your organ function does not meet the required thresholds - Your physical condition falls below the minimum score 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

DEVICECAR T cell injection

intravenous injection


Locations(2)

Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

InstituteHBDH

Tianjin, Tianjin Municipality, China

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NCT06355739


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