Clinical Trials in China / NCT07252336
Recruiting
Phase 2
A Multicenter Study of CAR-T Cells in Primary Ph+All
NCT07252336 · tracked via the Priya Life Science China tracker
Condition(s) studied
ALL
Investigational drug(s) / intervention(s)
CD19 CAR-T cells
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
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 | Hangzhou | Zhejiang | Recruiting |
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Official registry record
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.
View NCT07252336 on ClinicalTrials.gov ↗ ← All trials in China