Actively Recruiting
CD19/CD22 CAR-T Cell Therapy in MRD-Positive B-lineage Acute Lymphoblastic Leukemia in Children.
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
What this Trial Is About
In this study, CD19/CD22 dual-target CAR-T therapy will be carried out among children patients who are still positive after induction remission, and subsequent chemotherapy will continue after CAR-T cells exert their functions. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19/CD22 to treat MRD-positive ALL. The CAR-T cells were provided by Shenzhen Cell Valley. The results of the research team from Stanford University School of Medicine in the United States have already demonstrated the feasibility and safety of producing bispecific CD19/CD22.BB.z-CAR T cells in a closed system as well as the high clinical activity shown in the treatment of CAR19-resistant B-ALL (B-lineage acute lymphoblastic leukemia) and LBCL (Large B-cell lymphoma). The investigators look forward to expanding the application of CAR-T cells in MRD positive B-ALL through this clinical study on safety and efficacy and greatly improving the prognosis of children patients with this type of B-ALL.
CONDITIONS
Official Title
CD19/CD22 CAR-T Cell Therapy in MRD-Positive B-lineage Acute Lymphoblastic Leukemia in Children.
Who Can Participate
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
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Trial Site Locations
Total: 1 location
1
Guangzhou Medical University Affiliated Women and Children's Medical Center
Guangzhou, Guangdong, China, 510623
Actively Recruiting
Research Team
H
Hua Jiang, phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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