NCT07074496 Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
| NCT ID | NCT07074496 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-11-15 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-01-01 with a primary completion date of 2025-11-15.
⚠ 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
This is an Open, Prospective, Single-arm Study, which is designed to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Newly Diagnosed Ph-positive lymphoblastic leukemia.
Eligibility Criteria
Inclusion Criteria: 1. Male or non-pregnant, non-lactating female patients who are 18 years of age or older. 2. Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy. 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months. 4. Organ function as indicated by the following laboratory indicators must be met: 1\. Alanine aminotransferase (ALT) ≤ 5×upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 5×ULN; 2. Total bilirubin\<2×ULN; 3. 24-hour calculated creatinine clearance\>30 mL/min; 4. SpO2≥92%; 5. Cardiac ejection fraction (EF)≥40%; Exclusion Criteria: 1. Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Subjects with HBV-DNA \< 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.) ; 2. Uncontrolled active infection; 3. Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS; 4. Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \> 140mmHg and/or diastolic blood pressure \> 90mmHg); 5. Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is \>50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension; 6. Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL; 7. Patients who have any other malignant tumors that require treatment; 8. Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol/L); 9. Patients who are pregnant, planning to become pregnant or breastfeeding; 10. Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug; 11. Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures; 12. Patients who suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07074496 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. 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 NCT07074496 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07074496 currently recruiting?
Yes, NCT07074496 is actively recruiting participants. Contact the research team at chensuning@sina.com for enrollment information.
Where is the NCT07074496 trial being conducted?
This trial is being conducted at Suzhou, China, Suzhou, China.
Who is sponsoring the NCT07074496 clinical trial?
NCT07074496 is sponsored by The First Affiliated Hospital of Soochow University. The trial plans to enroll 20 participants.
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