Recruiting

CD19/CD22 CAR-T Cell Therapy for Children with MRD-Positive B-ALL

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What is being tested

CAR-T Therapy

Drug
Who is being recruted

Hematologic Diseases+8

+ Hemic and Lymphatic Diseases

+ Immune System Diseases

From 1 to 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorGuangzhou Women and Children's Medical Center
Study ContactHua Jiang, phd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on testing a new treatment called CAR-T cell therapy for children with a type of blood cancer known as B-lineage Acute Lymphoblastic Leukemia (B-ALL). Specifically, it targets those who still show signs of the disease after initial treatment, known as MRD-positive. The aim is to see if this treatment is safe and effective for these children, as current options might not fully eliminate cancer cells. Successful outcomes could lead to better treatment strategies for these young patients, potentially improving survival rates and quality of life. Participants in the study undergo a series of steps, starting with an initial screening to ensure they meet the criteria for treatment. After consenting, the child's own white blood cells are collected and modified in a lab to create CAR-T cells that target cancer cells. Before receiving the CAR-T cells through an intravenous infusion, participants undergo a preparatory treatment to reduce existing lymphocytes, using medications such as fludarabine and cyclophosphamide. The effectiveness of the treatment is assessed through tests measuring remaining cancer cells. Participants are closely monitored for side effects like CRS and ICANS, with follow-ups occurring frequently in the first month, gradually reducing to yearly check-ins over several years.

Official TitleClinical Study on the Safety and Efficacy of CD19/CD22 CAR-T Cell Therapy in MRD-Positive B-lineage Acute Lymphoblastic Leukemia in Children.
NCT06752785
Principal SponsorGuangzhou Women and Children's Medical Center
Study ContactHua Jiang, phd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Criteria

8 inclusion criteria required to participate
Parents or legal guardians fully understand, are informed of this study and sign the informed consent form (ICF); are willing to follow and can complete all test procedures.

Chinese children aged 1-18 years old at the time of screening, regardless of gender, with a body weight ≥ 10 kg.

Bone marrow examination confirms that MRD is still positive on the 46th day after induction remission.

Tumor cells in the bone marrow (BM) or peripheral blood (PB) express CD19/CD22 within 3 months before screening.

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11 exclusion criteria prevent from participating
Have genetic diseases, except Down syndrome.

Have a history of other malignancies or have other malignancies simultaneously.

Meet any of the following conditions: (1)hepatitis B surface antigen (HBsAg) positive or HBV DNA quantification higher than the upper limit of normal value; (2)hepatitis C antibody (HCV Ab) positive and HCV RNA quantification higher than the upper limit of normal value; (3)human immunodeficiency virus antibody (HIV-Ab) positive; (4)Treponema pallidum antibody (TP-Ab) positive; (5)EBV DNA higher than the upper limit of normal value; (6)cytomegalovirus DNA higher than the upper limit of normal value.

Have or are suspected to have uncontrolled or require intravenous drug treatment for fungal, bacterial, viral or other infections.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Children of MRD-Positive B-lineage Acute Lymphoblastic Leukemia; CD19/CD22 CAR-T

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Guangzhou Medical University Affiliated Women and Children's Medical Center

Guangzhou, ChinaOpen Guangzhou Medical University Affiliated Women and Children's Medical Center in Google Maps
Recruiting
One Study Center