Safety and Efficacy Study of CD19/CD22 CAR-T Cell Therapy
in Children with MRD-Positive B-lineage Acute Lymphoblastic Leukemia
Led by Guangzhou Women and Children's Medical Center · Updated on 2024-12-31
10
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
AI-Screening
Trial Site Locations
Research Team
How is the study designed?
Frequently Asked Questions
Published Results
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CD19/CD22 dual-target CAR-T cell therapy in children with minimal residual disease (MRD)-positive B-lineage acute lymphoblastic leukemia (B-ALL) who remain positive after induction remission. This phase 1, single-center, open-label study aims to improve outcomes by expanding the use of CAR-T cells in this patient population. The CAR-T cells used are retroviral vector-based tandem cells targeting CD19 and CD22, produced by Shenzhen Cell Valley, with encouraging prior results from Stanford University showing feasibility, safety, and clinical activity in similar blood cancers.
The treatment process involves screening patients to confirm eligibility, obtaining informed consent, and preparing CAR-T cells from the patient's own lymphocytes. Before infusion, patients receive lymphocyte depletion chemotherapy with fludarabine and cyclophosphamide. The CAR-T cells are then infused intravenously at a dose of 3 million cells per kilogram, with a permitted range between 2 and 4 million cells per kilogram. After one month of CAR-T treatment, patients continue chemotherapy according to the CCCG-ALL regimen starting from the second high-dose methotrexate consolidation phase. The study monitors adverse reactions such as cytokine release syndrome and neurotoxicity.
Participants undergo close follow-up after CAR-T infusion, including assessments on days 7, 14, 21, and 30 in the first month. Monthly follow-ups occur from months 2 to 6, then every three months up to 2 years, and yearly from 2 to 5 years, followed by long-term monitoring. Evaluations include MRD tests to measure treatment efficacy, organ function tests, and safety monitoring. The study aims to validate the treatment's impact one year after CAR-T therapy, involving comprehensive clinical and laboratory assessments throughout the participation period.
CONDITIONS
Official Title
CD19/CD22 CAR-T Cell Therapy in MRD-Positive B-lineage Acute Lymphoblastic Leukemia in Children.
Who Can Participate
Age: 1Year - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
Parents or legal guardians fully understand and agree to participate by signing the informed consent form.
Children aged 1 to 18 years, regardless of gender, weighing at least 10 kg.
Bone marrow examination shows MRD positive on day 46 after induction remission.
Tumor cells express CD19 or CD22 within 3 months before screening.
Good organ function: ALT ≤ 5 times upper normal limit; total bilirubin ≤ 2 times upper normal limit (≤ 3 times for Gilbert's syndrome); no more than grade 1 dyspnea without oxygen; oxygen saturation > 95%; left ventricular ejection fraction ≥ 50%; serum creatinine ≤ 1.5 times upper normal limit.
Karnofsky score ≥ 70 for those 16 years or older, Lansky score ≥ 50 for those under 16.
Expected survival of at least 12 weeks.
Sufficient venous access for blood collection and no contraindications for apheresis.
You will not qualify if you...
Presence of genetic diseases except Down syndrome.
History or presence of other cancers.
Positive for hepatitis B surface antigen or high HBV DNA; positive hepatitis C antibody with high HCV RNA; positive HIV antibody; positive Treponema pallidum antibody; elevated EBV or cytomegalovirus DNA.
Uncontrolled or requiring IV treatment for fungal, bacterial, viral, or other infections.
Use of long-acting G-CSF within 21 days or short-acting G-CSF within 7 days before screening.
Active central nervous system leukemia.
Allergy to albumin or aminoglycoside antibiotics.
Previous organ transplantation except hematopoietic stem cell transplant.
Participation in other interventional clinical studies within 3 months or planned anti-tumor treatments outside this protocol.
Unable to tolerate chemotherapy or cytokine storm due to organ dysfunction.
Other conditions deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
Guangzhou Medical University Affiliated Women and Children's Medical Center
Guangzhou, Guangdong, China, 510623
Actively Recruiting
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Research Team
H
Hua Jiang, phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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