NCT07252336 A Multicenter Study of CAR-T Cells in Primary Ph+All
| NCT ID | NCT07252336 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhejiang University |
| Condition | ALL |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-11-30 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-11-30 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07252336 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07252336 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07252336 currently recruiting?
Yes, NCT07252336 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT07252336 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07252336 clinical trial?
NCT07252336 is sponsored by Zhejiang University. The trial plans to enroll 50 participants.