Status:
COMPLETED
Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Yake Biotechnology Ltd.
Conditions:
B-Cell Acute Lymphoblastic Leukemia, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
Detailed Description
This study was designed as a prospective, open-label, single-center study. It aims to evaluate the efficacy and safety of CD19 CAR-T cells in combination with dasatinib for the treatment of newly diag...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old;
- Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia;
- Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene;
- Leukemia cells were CD19 and CD22 positive;
- Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens;
- Serum total bilirubin ≤ 51 mol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L;
- Echocardiography showed a left ventricular ejection fraction (LVEF) ≥50%;
- Subjects had no active pulmonary infection and oxygen saturation ≥92% without oxygen;
- The prognosis for survival is more than 3 months;
- ECOG score 0-2;
- Subjects volunteered to participate in this trial and signed an informed consent form.
Exclusion
- Subjects with any of the following exclusion criteria were not eligible for enrollment in this trial:
- Those with a history of epilepsy or other central nervous system disorders;
- Those with a history of prolonged QT period or severe cardiac disease;
- Women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known);
- Those with uncontrolled active infection;
- Active hepatitis B or hepatitis C virus infection;
- Those who have previously used any gene therapy product;
- Those with insufficient amplification (\<5-fold) in response to CD3/CD28 co-stimulatory signals;
- Creatinine \> 2.5 mg/dl or ALT / AST \> 3 times the upper limit of the normal range or bilirubin \> 2.0 mg/dl;
- Those who suffer from other uncontrolled medical conditions that, in the opinion of the investigator, make them unsuitable for enrollment;
- HIV-infected persons;
- Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the test.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04788472
Start Date
March 5 2021
End Date
August 31 2024
Last Update
October 17 2024
Active Locations (1)
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1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003