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حالة التجربة السريرية NCT07330895 لـ CD19+ Relapse/Refractory B-ALL هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
Clinical Study of LV009 Injection in the Treatment of Recurrent/Refractory CD19 Positive Blood Tumors المرحلة الأولى المبكرة ١٩ تجربة مفتوحة بمبادرة الباحث
Eligible subjects who have signed the informed consent form will receive an infusion of LV009 Injection. Blood samples will be ...
عرض المزيدClinical Study of LV009 Injection in the Treatment of Recurrent/Refractory CD19 Positive Blood Tumors
- PG-012-10
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةOn the Safety, Tolerability, and Efficacy of LV009 Injection in the Treatment of Lymphoma Single dose, single arm trial, exploring the initial 28 day safety and eicacy of the investigational drug. | Biological: LV009 injection The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into0.3×10\^9 TU\~2.4×10\^9 TU cells. |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Primary Outcome Measure | Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), RCL, and lentiviral integration site status (according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0, NCI CTCAE v5.0) | 2 years |
Age ≥18 years, regardless of race.
Expected survival time exceeds 12 weeks.
ECOG score 0-2.
Meets the NCCN/CSCO guideline-defined criteria for relapsed/refractory disease and confirmed CD19-positive hematologic malignancy.
Liver, kidney, heart, and lung functions meet the following requirements:
- Creatinine ≤1.5×ULN;
- Left ventricular ejection fraction ≥45%;
- Oxygen saturation >91%;
- Total bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN.
Absolute lymphocyte count ≥0.5×10⁹/L; platelet count ≥50×10⁹/L; CD3-positive T cells ≥150/uL.
Prophylactic anti-allergy medications (e.g., promethazine, diphenhydramine) should be administered 15-30 minutes before investigational drug infusion to prevent cryoprotectant (e.g., DMSO)-related infusion reactions.
Subjects must have a body temperature ≤38°C within 24 hours before investigational drug infusion (excluding tumor fever).
Within 5 days prior to investigational drug infusion, subjects must not receive therapeutic doses of corticosteroids (>5mg/day prednisone or equivalent) or other immunosuppressive drugs.
Before investigational drug infusion, subjects must meet the required washout period per Appendix 3 (Drug/Treatment Discontinuation Schedule). (11) Capable of understanding the trial and having signed informed consent.
- Patients judged by investigators to require long-term use of immunosuppressants during screening.
- Occurrence of cerebrovascular accident or seizure within 3 months prior to signing informed consent.
- Presence of other active malignancies besides the studied disease, excluding carcinoma in situ.
- Peripheral blood hepatitis B virus (HBV) DNA titer exceeding normal reference range.
- Severe cardiac diseases including but not limited to: unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA class ≥III), severe arrhythmia.
- Unstable systemic diseases judged by investigators including but not limited to severe hepatic, renal or metabolic diseases requiring medication.
- Patients whose acute toxic effects from prior treatment have not yet resolved.
- Active or uncontrolled infections requiring systemic treatment (excluding mild genitourinary and upper respiratory infections).
- Female subjects of childbearing potential planning pregnancy within 2 years after investigational drug infusion; or male subjects whose partners plan pregnancy within 2 years after infusion.
- Prohibited use of investigational drug when following complications exist: clinical evidence of active infection, fluid overload or congestive heart failure, drug-uncontrolled arrhythmia, hypotension requiring vasopressor support.Other situations deemed unsuitable for enrollment/investigational drug infusion by investigators.
The First Affiliated Hospital with Nanjing Medical University