Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL
Study Details
Study Description
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 Positive B-cell Acute Lymphoblastic Leukemia
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
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 positive B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CAR-T therapy Administration of CD19 and CD22 CAR T-cells |
Drug: CAR-T cells targeting CD19 and CD22
Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
Ageā„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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310003 |
Sponsors and Collaborators
- Zhejiang University
- Yake Biotechnology Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CD19-006