Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL

Zhejiang University

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

B-Cell Acute Lymphoblastic Leukemia, Adult

Treatments

Drug: CAR-T cells targeting CD19 and CD22

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04740203

CD19-005

Details and patient eligibility

About

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

Full 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).

Enrollment

50 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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.