CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Oct 5, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called CD19CD22 CAR-T therapy for adults who have recently been diagnosed with high-risk B Acute Lymphoblastic Leukemia (B-ALL). The goal of the study is to see how safe and effective this therapy is when combined with a specific type of chemotherapy. Researchers are looking for participants aged 18 to 65 who have a specific type of leukemia and are expected to live for at least 12 weeks. It’s important that potential participants have leukemia cells that test positive for CD19 and CD22, and do not have certain health issues or infections that could complicate their treatment.

If you or someone you know meets these criteria and is interested in participating, they would receive the new CAR-T therapy after undergoing initial chemotherapy. During the trial, participants will be closely monitored for their safety and how well the treatment works. This study is currently recruiting participants, and those who take part will be contributing to important research that could help improve treatments for others with this type of leukemia in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age≥18 and ≤65 years old
• • 2. Newly diagnosed and high risk B-ALL according to the 2022 WHO classification
• • 3. The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;
• • 4. Anticipated survival time more than 12 weeks;
• • 5. Those who voluntarily participated in this trial and provided informed consent.
• Exclusion Criteria:
• • 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
• • 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• • 3. Pregnant (or lactating) women;
• • 4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• • 5. Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus
• • 6. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
• • 7. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
• • 8. Other uncontrolled diseases that were not suitable for this trial;
• • 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.