RecruitingPhase 2NCT05334823

A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents

A Phase II Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of CD19-positive Relapsed/Refractory B-ALL

Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

100 participants

Start Date

Jan 26, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia Refractory Acute Lymphoblastic Leukemia Relapsed Pediatric ALL

Summary

This is a phase II clinical study to evaluate the safety and efficacy of pCAR-19 B cell autologous infusion preparation in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.

Eligibility

Min Age: 3 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR-T cell therapy called pCAR-19B in children and teenagers whose B-cell leukemia (B-ALL) has come back or didn't respond to standard treatment. CAR-T therapy involves reprogramming your own immune cells to find and kill cancer cells. **You may be eligible if...** - You are a child or adolescent diagnosed with CD19-positive B-ALL (a type of leukemia) - Your leukemia came back within 12 months of achieving remission (early relapse) - Your leukemia came back after 12+ months but didn't respond to standard retreatment - You failed to achieve complete remission after 2 standard chemotherapy courses - You or your guardian has agreed to participate and signed the consent form **You may NOT be eligible if...** - Your cancer does not express the CD19 protein - You do not meet the criteria for relapsed or refractory disease 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

BIOLOGICALpCAR-19B cells

Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Locations(10)

Beijing Children's Hospital.Capital Medical University

Beijing, Beijing Municipality, China

Beijing GoBroad Boren Hospital

Beijing, Beijing Municipality, China

Pediatric Hematology department of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiehe Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Children's Hospital Of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

West China Second University Hospital,Sichuan University

Chengdu, Sichuan, China

Institute Of Hematology&Blood Diseases Hospital,Chinese Academy Of Medicai Sciences

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05334823

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