RecruitingPhase 1Phase 2NCT05667506

A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)

A Phase Ib/II, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of CNCT19 in Children and Adolescent(Pediatric) Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)


Sponsor

Juventas Cell Therapy Ltd.

Enrollment

47 participants

Start Date

Feb 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).


Eligibility

Min Age: 3 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy called CNCT19 for children and teenagers whose acute lymphoblastic leukemia (ALL) — a type of blood cancer — has come back or stopped responding to treatment. CAR-T therapy uses a patient's own immune cells, which are reprogrammed in a lab to find and destroy cancer cells. **You may be eligible if...** - You are 3 to 18 years old and weigh at least 10 kg - You have relapsed or refractory ALL (cancer came back or didn't respond to treatment) - Your cancer cells test positive for a protein called CD19 - Your bone marrow has at least 5% cancer cells at the time of screening - You have adequate organ function (heart, liver, kidneys) **You may NOT be eligible if...** - You have uncontrolled active infections - You have received certain other experimental treatments recently - Your cancer does not have the CD19 marker - You have severe organ dysfunction 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

BIOLOGICALsingle dose of CNCT19

Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously. Lymphodepletion treatment: Drugs:Fludarabine Drugs: Cyclophosphamide


Locations(9)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

Union Hospital Tongji Medical College Huazhong University of Science of Technology

Wuhan, Hubei, China

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Affilicated Hospital of Nanchang University

Nanchang, Jiangxi, China

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05667506


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