Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL
- Conditions
- B-Cell Acute Lymphoblastic Leukemia, Adult
- Interventions
- Drug: CAR-T cells targeting CD19 and CD22
- Registration Number
- NCT04740203
- Lead Sponsor
- Zhejiang University
- Brief Summary
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia
- Detailed Description
This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome negative B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Age≥15 years old
- Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification
- The immunophenotype of leukemia cells were CD19 and CD22 positive
- Ph- or Ph- like negative
- Anticipated survival time more than 12 weeks;
- Those who voluntarily participated in this trial and provided informed consent.
- 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);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
- 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;
- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CAR-T therapy CAR-T cells targeting CD19 and CD22 Administration of CD19 and CD22 CAR T-cells
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) Up to 2 years after CAR-T cells infusion Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Dose-limiting toxicity (DLT) Baseline up to 28 days after CAR-T cells infusion Adverse events assessed according to NCI-CTCAE v5.0 criteria
- Secondary Outcome Measures
Name Time Method Complete Remission Rate up to 28 days after CAR-T cells infusion Complete Remission Rate after CAR-T cell therapy
Overall survival (OS) Up to 2 years after CD19 CAR-T cells infusion From the first infusion of CD19 CAR-T cells to death or the last visit
Leukemia-free survival (LFS) Up to 2 years after CD19 CAR-T cells infusion From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit
Quality of life At Baseline, Month 1, 3, 6, 9 and 12 Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale \[For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome\] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12
Trial Locations
- Locations (1)
The First Affiliated Hospital, College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China