CD19 CAR-T cells: Each subject receive CD19/CD22 CAR T-cells by intravenous infusion
Study summary
A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years old, gender not restricted;
2. Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;
3. Abnormal B cells positive for CD19 and CD22 by immunophenotyping;
4. Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing;
5. Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens;
6. Serum total bilirubin ≤ 51 μmol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal reference range, and serum creatinine ≤ 176.8 μmol/L;
7. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography;
8. Subjects with no active pulmonary infection and oxygen saturation ≥ 92% without oxygen supplementation;
9. Estimated survival time ≥ 3 months;
10. ECOG performance status score 0-2;
11. Females and males of childbearing potential must agree to use appropriate contraceptive measures before enrollment, during study participation, and within 6 months after infusion;
12. Subjects voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria:
* Subjects meeting any of the following exclusion criteria are ineligible for enrollment in this study:
1. Subjects with a history of epilepsy or other central nervous system diseases;
2. Subjects with a prior history of QT interval prolongation or severe cardiac diseases;
3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
4. Subjects with untreated active infections;
5. Subjects with serological evidence of chronic hepatitis B virus (HBV) infection who are unable or unwilling to receive standard prophylactic antiviral treatment, or have a detectable HBV viral DNA load; subjects with serological evidence of hepatitis C virus (HCV) infection who have not completed curative treatment or have a detectable HCV viral load;
6. Human immunodeficiency virus (HIV) antibody positive;
7. Syphilis antibody positive;
8. Subjects who have previously received any gene therapy products;
9. Subjects with other uncontrolled diseases who, in the investigator's judgment, are unsuitable for enrollment;
10. Any other conditions that, in the investigator's judgment, may increase the risk to the subject or interfere with the study results.
Primary outcome measure(s)
Complete Molecular Response Rate after CD19 CAR-T Cell Therapy — 28 days after infusion Laboratory tests
Trial sites (1)
Facility
City
Region
Status
The first affiliated hospital of medical college of zhejiang university
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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