Clinical trial NCT04740203: Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: B-Cell Acute Lymphoblastic Leukemia, Adult
Keywords: CD19 CAR-T
CD22 CAR-T
Ph Chromosome Negative
B-ALL
Newly diagnosed
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Yake Biotechnology Ltd.
First posted: 2021-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Baseline up to 28 days after CAR-T cells infusion
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 2 years after CAR-T cells infusion
Secondary outcomes:
measure: Complete Remission Rate
timeFrame: up to 28 days after CAR-T cells infusion
measure: Overall survival (OS)
timeFrame: Up to 2 years after CD19 CAR-T cells infusion
measure: Leukemia-free survival (LFS)
timeFrame: Up to 2 years after CD19 CAR-T cells infusion
measure: Quality of life
timeFrame: At Baseline, Month 1, 3, 6, 9 and 12
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: