B-Cell Acute Lymphoblastic Leukemia, Adult
Conditions
Keywords
CD19 CAR-T, CD22 CAR-T, Ph Chromosome Negative, B-ALL, Newly diagnosed
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).
Interventions
Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
Sponsors
Yake Biotechnology Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
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); * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | Baseline up to 28 days after CAR-T cells infusion | Adverse events assessed according to NCI-CTCAE v5.0 criteria |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 2 years after CAR-T cells infusion | Incidence of treatment-emergent adverse events \[Safety and Tolerability\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactHe Huang, PhD
Backup ContactMingming Zhang, PhD
Outcome results
None listed