CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL). (NCT06078306) | Clinical Trial Compass
UnknownPhase 2
CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).
China20 participantsStarted 2024-04-20
Plain-language summary
Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age≥18 and ≤65 years old
✓. Newly diagnosed and high risk B-ALL according to the 2022 WHO classification
✓. The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;
✓. Anticipated survival time more than 12 weeks;
✓. Those who voluntarily participated in this trial and provided informed consent.
Exclusion criteria
✕. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
✕. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
✕. Pregnant (or lactating) women;
✕. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
✕. Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus
✕. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
✕. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
✕
What they're measuring
1
Complete Remission Rate
Timeframe: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
Trial details
NCT IDNCT06078306
SponsorThe First Affiliated Hospital of Soochow University